The purpose of this study is to determine whether deep brain stimulation of the basolateral nucleus (BLn) of the amygdala, on both sides of the brain, can safely reduce symptoms of post-traumatic stress disorder (PTSD) in combat veterans whose condition has not improved despite extensive treatment with currently available medication and psychotherapy interventions.
For this pilot feasibility study, combat veterans whose PTSD has been associated with severe symptomatic suffering and functional impairment, despite treatment with all currently available pharmacological and psychotherapeutic treatments, will be recruited from clinics at a large, academically affiliated VA facility. An extensive screening over an extended baseline by the study psychiatrist and neurosurgeon will be conducted using standard interviews and clinical rating scales. Eligible subjects are required to have a cohabiting significant other willing to participate in safety and function monitoring throughout the study. After successful completion of baseline eligibility requirements, comprehensive neuropsychological testing will be performed, as will structural MRI and FDG PET/CT of the amygdala, insula and medial Prefrontal cortex. PET/CT will be performed and analyzed by a nuclear medicine specialist collaborator familiar with this type of imaging research. Six consenting subjects meeting all eligibility criteria will then receive bilateral basolateral nucleus of the amygdala (BlnA) implantation of Medtronic Activa Primary Cell (PC) implantable deep brain stimulator systems (purchased through the VA Merit Review Grant) by functional neurosurgeons specialized in the procedure. This will be done during a 3-4 day inpatient stay on the VA Greater Los Angeles Neurosurgical Service. After a month of weekly safety monitoring with stimulators off, subjects will be will be hospitalized for 1 day on the Neurology Service's electroencephalography (EEG) telemetry unit, under the care and supervision of an epilepsy specialist neurologist who is a co-investigator in the study, for stimulator initiation. Stimulator settings will be adjusted by the study clinical neurophysiologist while patients are monitored by the study neurologist and psychiatrist. Only stimulator settings that do not cause epileptiform discharges, or potentially significant adverse psychiatric or medical (e.g., blood pressure, heart rate) changes will be used over the subsequent long-term follow-up. After the EEG telemetry safety check, subjects will be randomized (3/3) to either have their stimulators turned on then (Week 0), or 3 months later (week 12). This staggered onset double-blind design has been used in other DBS trials in psychiatry. After week 0, for the next 2 years, subjects will be followed at regular intervals (weekly for 5 months, then monthly for 7 months, then quarterly for 12 months) by a psychiatrist, neurosurgeon, neurologist and neurophysiologist who will conduct an extensive battery of psychiatric and neurological testing (including periodic EEG recordings), as well as significant other interviews, while stimulator settings are adjusted based on standardized rating scale outcomes and adverse effects so as to optimize treatment outcome. The principal study hypothesis is that the symptomatic and functional benefits of chronic stimulation will outweigh the risks and adverse-effects, and that symptomatic improvement will be greater, without unacceptable adverse effects, in subjects with week 0, compared to week 12 stimulator initiation. Neuropsychological testing will be repeated after 6 months of stimulation to assess changes in cognitive function. Functional neuroimaging with PET/CT will be repeated after a year of stimulation to assess changes in the activity of brain regions known to function abnormally in PTSD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Subjects undergo the placement of a Leksell (Elekta, Atlanta, GE) stereotactic frame. Electrode trajectory planned using stereotactic software (BrainLab, Germany). Traditional trans-frontal trajectory used to implant Medtronic #3387 DBS electrodes bilaterally in the BLn. A curvilinear incision will be made 3 cm lateral to midline and 1 cm in front of the coronal suture. A burr hole will be placed with a high-speed drill for placement of a Stimloc device to hold the electrode in place. The dura will be opened, coagulated back and the cortex exposed, coagulated, and pierced. The electrode will be introduced using a cannula. Each electrode contact will be stimulated up to 7 V to confirm the absence of immediate side effects; first left, then right. Electrode wires will be tunneled under skin to upper chest and connected to Medtronic Activa PC dual channel pulse generator. Both groups keep stimulators off until week 0, then this group has stimulators turned on.
Subjects undergo the placement of a Leksell (Elekta, Atlanta, GE) stereotactic frame. Electrode trajectory planned using stereotactic software (BrainLab, Germany). Traditional trans-frontal trajectory used to implant Medtronic #3387 DBS electrodes bilaterally in the BLn. A curvilinear incision will be made 3 cm lateral to midline and 1 cm in front of the coronal suture. A burr hole will be placed with a high-speed drill for placement of a Stimloc device to hold the electrode in place. The dura will be opened, coagulated back and the cortex exposed, coagulated, and pierced. The electrode will be introduced using a cannula. Each electrode contact will be stimulated up to 7 V to confirm the absence of immediate side effects; first left, then right. Electrode wires will be tunneled under skin to upper chest and connected to Medtronic Activa PC dual channel pulse generator. Both groups keep stimulators off until week 0. This group has stimulators turned on at week 12.
VA Greater Los Angeles Healthcare System
Los Angeles, California, United States
The Clinician-Administered PTSD scale (CAPS) will be the primary outcome measure. A clinical response will be defined as a reduction of 30 % in CAPSSx from baseline to 12 months post-stimulation, without adverse events leading to stopping stimulation.
This is a standardized structured, clinician administered interview that includes both questions confirming the diagnosis of PTSD (CAPSDx) as well as symptom severity over specified time periods (lifetime, past week or past month) based on the 17 symptoms of PTSD in DSM-III/II-R and IV across clusters of recurrence, avoidance/numbing and hyper-arousal symptoms (CAPS1-17 or CAPSSx).
Time frame: 12 months
The Clinician-Administered PTSD scale (CAPS) change from week 0
This is a standardized structured, clinician administered interview that includes both questions confirming the diagnosis of PTSD (CAPSDx) as well as symptom severity over specified time periods (lifetime, past week or past month) based on the 17 symptoms of PTSD in DSM-III/II-R and IV across clusters of recurrence, avoidance/numbing and hyper-arousal symptoms (CAPS1-17 or CAPSSx).
Time frame: 1 month
The Clinician-Administered PTSD scale (CAPS) change from week 0
This is a standardized structured, clinician administered interview that includes both questions confirming the diagnosis of PTSD (CAPSDx) as well as symptom severity over specified time periods (lifetime, past week or past month) based on the 17 symptoms of PTSD in DSM-III/II-R and IV across clusters of recurrence, avoidance/numbing and hyper-arousal symptoms (CAPS1-17 or CAPSSx).
Time frame: 2months
The Clinician-Administered PTSD scale (CAPS) change from week 0
This is a standardized structured, clinician administered interview that includes both questions confirming the diagnosis of PTSD (CAPSDx) as well as symptom severity over specified time periods (lifetime, past week or past month) based on the 17 symptoms of PTSD in DSM-III/II-R and IV across clusters of recurrence, avoidance/numbing and hyper-arousal symptoms (CAPS1-17 or CAPSSx).
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Time frame: 3 months
The Clinician-Administered PTSD scale (CAPS) change from week 0
This is a standardized structured, clinician administered interview that includes both questions confirming the diagnosis of PTSD (CAPSDx) as well as symptom severity over specified time periods (lifetime, past week or past month) based on the 17 symptoms of PTSD in DSM-III/II-R and IV across clusters of recurrence, avoidance/numbing and hyper-arousal symptoms (CAPS1-17 or CAPSSx).
Time frame: 4 months
The Clinician-Administered PTSD scale (CAPS) change from week 0
This is a standardized structured, clinician administered interview that includes both questions confirming the diagnosis of PTSD (CAPSDx) as well as symptom severity over specified time periods (lifetime, past week or past month) based on the 17 symptoms of PTSD in DSM-III/II-R and IV across clusters of recurrence, avoidance/numbing and hyper-arousal symptoms (CAPS1-17 or CAPSSx).
Time frame: 5 months
The Clinician-Administered PTSD scale (CAPS) change from week 0
This is a standardized structured, clinician administered interview that includes both questions confirming the diagnosis of PTSD (CAPSDx) as well as symptom severity over specified time periods (lifetime, past week or past month) based on the 17 symptoms of PTSD in DSM-III/II-R and IV across clusters of recurrence, avoidance/numbing and hyper-arousal symptoms (CAPS1-17 or CAPSSx).
Time frame: 6 months
The Clinician-Administered PTSD scale (CAPS) change from week 0
This is a standardized structured, clinician administered interview that includes both questions confirming the diagnosis of PTSD (CAPSDx) as well as symptom severity over specified time periods (lifetime, past week or past month) based on the 17 symptoms of PTSD in DSM-III/II-R and IV across clusters of recurrence, avoidance/numbing and hyper-arousal symptoms (CAPS1-17 or CAPSSx).
Time frame: 7 months
The Clinician-Administered PTSD scale (CAPS) change from week 0
This is a standardized structured, clinician administered interview that includes both questions confirming the diagnosis of PTSD (CAPSDx) as well as symptom severity over specified time periods (lifetime, past week or past month) based on the 17 symptoms of PTSD in DSM-III/II-R and IV across clusters of recurrence, avoidance/numbing and hyper-arousal symptoms (CAPS1-17 or CAPSSx).
Time frame: 8 months
The Clinician-Administered PTSD scale (CAPS) change from week 0
This is a standardized structured, clinician administered interview that includes both questions confirming the diagnosis of PTSD (CAPSDx) as well as symptom severity over specified time periods (lifetime, past week or past month) based on the 17 symptoms of PTSD in DSM-III/II-R and IV across clusters of recurrence, avoidance/numbing and hyper-arousal symptoms (CAPS1-17 or CAPSSx).
Time frame: 9 months
The Clinician-Administered PTSD scale (CAPS) change from week 0
This is a standardized structured, clinician administered interview that includes both questions confirming the diagnosis of PTSD (CAPSDx) as well as symptom severity over specified time periods (lifetime, past week or past month) based on the 17 symptoms of PTSD in DSM-III/II-R and IV across clusters of recurrence, avoidance/numbing and hyper-arousal symptoms (CAPS1-17 or CAPSSx).
Time frame: 10 months
The Clinician-Administered PTSD scale (CAPS) change from week 0
This is a standardized structured, clinician administered interview that includes both questions confirming the diagnosis of PTSD (CAPSDx) as well as symptom severity over specified time periods (lifetime, past week or past month) based on the 17 symptoms of PTSD in DSM-III/II-R and IV across clusters of recurrence, avoidance/numbing and hyper-arousal symptoms (CAPS1-17 or CAPSSx).
Time frame: 11 months
The Clinician-Administered PTSD scale (CAPS) change from week 0
This is a standardized structured, clinician administered interview that includes both questions confirming the diagnosis of PTSD (CAPSDx) as well as symptom severity over specified time periods (lifetime, past week or past month) based on the 17 symptoms of PTSD in DSM-III/II-R and IV across clusters of recurrence, avoidance/numbing and hyper-arousal symptoms (CAPS1-17 or CAPSSx).
Time frame: 13 months
The Clinician-Administered PTSD scale (CAPS) change from week 0
This is a standardized structured, clinician administered interview that includes both questions confirming the diagnosis of PTSD (CAPSDx) as well as symptom severity over specified time periods (lifetime, past week or past month) based on the 17 symptoms of PTSD in DSM-III/II-R and IV across clusters of recurrence, avoidance/numbing and hyper-arousal symptoms (CAPS1-17 or CAPSSx).
Time frame: 14 months
The Clinician-Administered PTSD scale (CAPS) change from week 0
This is a standardized structured, clinician administered interview that includes both questions confirming the diagnosis of PTSD (CAPSDx) as well as symptom severity over specified time periods (lifetime, past week or past month) based on the 17 symptoms of PTSD in DSM-III/II-R and IV across clusters of recurrence, avoidance/numbing and hyper-arousal symptoms (CAPS1-17 or CAPSSx).
Time frame: 15 months
The Clinician-Administered PTSD scale (CAPS) change from week 0
This is a standardized structured, clinician administered interview that includes both questions confirming the diagnosis of PTSD (CAPSDx) as well as symptom severity over specified time periods (lifetime, past week or past month) based on the 17 symptoms of PTSD in DSM-III/II-R and IV across clusters of recurrence, avoidance/numbing and hyper-arousal symptoms (CAPS1-17 or CAPSSx).
Time frame: 18 months
The Clinician-Administered PTSD scale (CAPS) change from week 0
This is a standardized structured, clinician administered interview that includes both questions confirming the diagnosis of PTSD (CAPSDx) as well as symptom severity over specified time periods (lifetime, past week or past month) based on the 17 symptoms of PTSD in DSM-III/II-R and IV across clusters of recurrence, avoidance/numbing and hyper-arousal symptoms (CAPS1-17 or CAPSSx).
Time frame: 21 months
The Clinician-Administered PTSD scale (CAPS) change from week 0
This is a standardized structured, clinician administered interview that includes both questions confirming the diagnosis of PTSD (CAPSDx) as well as symptom severity over specified time periods (lifetime, past week or past month) based on the 17 symptoms of PTSD in DSM-III/II-R and IV across clusters of recurrence, avoidance/numbing and hyper-arousal symptoms (CAPS1-17 or CAPSSx).
Time frame: 24 months
Hamilton Anxiety Rating Scale (HAM-A) change from week 0
Clinician administered scale to rate cross-sectional severity of generalized anxiety symptoms
Time frame: 3 months
Hamilton Anxiety Rating Scale (HAM-A) change from week 0
Clinician administered scale to rate cross-sectional severity of generalized anxiety symptoms
Time frame: 6 months
Hamilton Anxiety Rating Scale (HAM-A) change from week 0
Clinician administered scale to rate cross-sectional severity of generalized anxiety symptoms
Time frame: 9 months
Hamilton Anxiety Rating Scale (HAM-A) change from week 0
Clinician administered scale to rate cross-sectional severity of generalized anxiety symptoms
Time frame: 12 months
Hamilton Anxiety Rating Scale (HAM-A) change from week 0
Clinician administered scale to rate cross-sectional severity of generalized anxiety symptoms
Time frame: 15 months
Hamilton Anxiety Rating Scale (HAM-A) change from week 0
Clinician administered scale to rate cross-sectional severity of generalized anxiety symptoms
Time frame: 18 months
Hamilton Anxiety Rating Scale (HAM-A) change from week 0
Clinician administered scale to rate cross-sectional severity of generalized anxiety symptoms
Time frame: 21 months
Hamilton Anxiety Rating Scale (HAM-A) change from week 0
Clinician administered scale to rate cross-sectional severity of generalized anxiety symptoms
Time frame: 24 months
Montgomery Asberg Depression Rating Scale (MADRS) change from week 0
The MADRS is a 10 item clinician administered rating instrument with each item rated on a 7 point (0-6) scale to evaluate the severity of depressive symptoms in patients diagnosed with a depressive disorder. It is designed to evaluate for change in depressive state during treatment. Total scores range from 0-52 with score interpretation of: 7 recovered, 15 mild depression, 25 moderate depression, 31 severe and 44 very severe depression.
Time frame: 1 month
Montgomery Asberg Depression Rating Scale (MADRS) change from week 0
The MADRS is a 10 item clinician administered rating instrument with each item rated on a 7 point (0-6) scale to evaluate the severity of depressive symptoms in patients diagnosed with a depressive disorder. It is designed to evaluate for change in depressive state during treatment. Total scores range from 0-52 with score interpretation of: 7 recovered, 15 mild depression, 25 moderate depression, 31 severe and 44 very severe depression.
Time frame: 3 months
Montgomery Asberg Depression Rating Scale (MADRS) change from week 0
The MADRS is a 10 item clinician administered rating instrument with each item rated on a 7 point (0-6) scale to evaluate the severity of depressive symptoms in patients diagnosed with a depressive disorder. It is designed to evaluate for change in depressive state during treatment. Total scores range from 0-52 with score interpretation of: 7 recovered, 15 mild depression, 25 moderate depression, 31 severe and 44 very severe depression.
Time frame: 4 months
Montgomery Asberg Depression Rating Scale (MADRS) change from week 0
The MADRS is a 10 item clinician administered rating instrument with each item rated on a 7 point (0-6) scale to evaluate the severity of depressive symptoms in patients diagnosed with a depressive disorder. It is designed to evaluate for change in depressive state during treatment. Total scores range from 0-52 with score interpretation of: 7 recovered, 15 mild depression, 25 moderate depression, 31 severe and 44 very severe depression.
Time frame: 5 months
Montgomery Asberg Depression Rating Scale (MADRS) change from week 0
The MADRS is a 10 item clinician administered rating instrument with each item rated on a 7 point (0-6) scale to evaluate the severity of depressive symptoms in patients diagnosed with a depressive disorder. It is designed to evaluate for change in depressive state during treatment. Total scores range from 0-52 with score interpretation of: 7 recovered, 15 mild depression, 25 moderate depression, 31 severe and 44 very severe depression.
Time frame: 6 months
Montgomery Asberg Depression Rating Scale (MADRS) change from week 0
The MADRS is a 10 item clinician administered rating instrument with each item rated on a 7 point (0-6) scale to evaluate the severity of depressive symptoms in patients diagnosed with a depressive disorder. It is designed to evaluate for change in depressive state during treatment. Total scores range from 0-52 with score interpretation of: 7 recovered, 15 mild depression, 25 moderate depression, 31 severe and 44 very severe depression.
Time frame: 7 months
Montgomery Asberg Depression Rating Scale (MADRS) change from week 0
The MADRS is a 10 item clinician administered rating instrument with each item rated on a 7 point (0-6) scale to evaluate the severity of depressive symptoms in patients diagnosed with a depressive disorder. It is designed to evaluate for change in depressive state during treatment. Total scores range from 0-52 with score interpretation of: 7 recovered, 15 mild depression, 25 moderate depression, 31 severe and 44 very severe depression.
Time frame: 8 months
Montgomery Asberg Depression Rating Scale (MADRS) change from week 0
The MADRS is a 10 item clinician administered rating instrument with each item rated on a 7 point (0-6) scale to evaluate the severity of depressive symptoms in patients diagnosed with a depressive disorder. It is designed to evaluate for change in depressive state during treatment. Total scores range from 0-52 with score interpretation of: 7 recovered, 15 mild depression, 25 moderate depression, 31 severe and 44 very severe depression.
Time frame: 9 months
Montgomery Asberg Depression Rating Scale (MADRS) change from week 0
The MADRS is a 10 item clinician administered rating instrument with each item rated on a 7 point (0-6) scale to evaluate the severity of depressive symptoms in patients diagnosed with a depressive disorder. It is designed to evaluate for change in depressive state during treatment. Total scores range from 0-52 with score interpretation of: 7 recovered, 15 mild depression, 25 moderate depression, 31 severe and 44 very severe depression.
Time frame: 10 months
Montgomery Asberg Depression Rating Scale (MADRS) change from week 0
The MADRS is a 10 item clinician administered rating instrument with each item rated on a 7 point (0-6) scale to evaluate the severity of depressive symptoms in patients diagnosed with a depressive disorder. It is designed to evaluate for change in depressive state during treatment. Total scores range from 0-52 with score interpretation of: 7 recovered, 15 mild depression, 25 moderate depression, 31 severe and 44 very severe depression.
Time frame: 11 months
Montgomery Asberg Depression Rating Scale (MADRS) change from week 0
The MADRS is a 10 item clinician administered rating instrument with each item rated on a 7 point (0-6) scale to evaluate the severity of depressive symptoms in patients diagnosed with a depressive disorder. It is designed to evaluate for change in depressive state during treatment. Total scores range from 0-52 with score interpretation of: 7 recovered, 15 mild depression, 25 moderate depression, 31 severe and 44 very severe depression.
Time frame: 12 months
Montgomery Asberg Depression Rating Scale (MADRS) change from week 0
The MADRS is a 10 item clinician administered rating instrument with each item rated on a 7 point (0-6) scale to evaluate the severity of depressive symptoms in patients diagnosed with a depressive disorder. It is designed to evaluate for change in depressive state during treatment. Total scores range from 0-52 with score interpretation of: 7 recovered, 15 mild depression, 25 moderate depression, 31 severe and 44 very severe depression.
Time frame: 13 months
Montgomery Asberg Depression Rating Scale (MADRS) change from week 0
The MADRS is a 10 item clinician administered rating instrument with each item rated on a 7 point (0-6) scale to evaluate the severity of depressive symptoms in patients diagnosed with a depressive disorder. It is designed to evaluate for change in depressive state during treatment. Total scores range from 0-52 with score interpretation of: 7 recovered, 15 mild depression, 25 moderate depression, 31 severe and 44 very severe depression.
Time frame: 14 months
Montgomery Asberg Depression Rating Scale (MADRS) change from week 0
The MADRS is a 10 item clinician administered rating instrument with each item rated on a 7 point (0-6) scale to evaluate the severity of depressive symptoms in patients diagnosed with a depressive disorder. It is designed to evaluate for change in depressive state during treatment. Total scores range from 0-52 with score interpretation of: 7 recovered, 15 mild depression, 25 moderate depression, 31 severe and 44 very severe depression.
Time frame: 15 months
Montgomery Asberg Depression Rating Scale (MADRS) change from week 0
The MADRS is a 10 item clinician administered rating instrument with each item rated on a 7 point (0-6) scale to evaluate the severity of depressive symptoms in patients diagnosed with a depressive disorder. It is designed to evaluate for change in depressive state during treatment. Total scores range from 0-52 with score interpretation of: 7 recovered, 15 mild depression, 25 moderate depression, 31 severe and 44 very severe depression.
Time frame: 18 months
Montgomery Asberg Depression Rating Scale (MADRS) change from week 0
The MADRS is a 10 item clinician administered rating instrument with each item rated on a 7 point (0-6) scale to evaluate the severity of depressive symptoms in patients diagnosed with a depressive disorder. It is designed to evaluate for change in depressive state during treatment. Total scores range from 0-52 with score interpretation of: 7 recovered, 15 mild depression, 25 moderate depression, 31 severe and 44 very severe depression.
Time frame: 21 months
Montgomery Asberg Depression Rating Scale (MADRS) change from week 0
The MADRS is a 10 item clinician administered rating instrument with each item rated on a 7 point (0-6) scale to evaluate the severity of depressive symptoms in patients diagnosed with a depressive disorder. It is designed to evaluate for change in depressive state during treatment. Total scores range from 0-52 with score interpretation of: 7 recovered, 15 mild depression, 25 moderate depression, 31 severe and 44 very severe depression.
Time frame: 24 months
Young Mania Rating Scale (YMRS) change from week 0
The YMRS is an 11-item clinician-administered cross-sectional rating instrument used to assess the severity of mania in patients with a diagnosis of bipolar disorder. The 11 items are: Elevated Mood, Increased Motor Activity/Energy, Sexual Interest, Sleep, Irritability, Speech (Rate and Amount), Language - Thought Disorder, Content, Disruptive/Aggressive Behaviour, Appearance and Insight. Ratings are based on patient self-reporting, combined with clinician observation (accorded greater score).
Time frame: 1 month
Young Mania Rating Scale (YMRS) change from week 0
The YMRS is an 11-item clinician-administered cross-sectional rating instrument used to assess the severity of mania in patients with a diagnosis of bipolar disorder. The 11 items are: Elevated Mood, Increased Motor Activity/Energy, Sexual Interest, Sleep, Irritability, Speech (Rate and Amount), Language - Thought Disorder, Content, Disruptive/Aggressive Behaviour, Appearance and Insight. Ratings are based on patient self-reporting, combined with clinician observation (accorded greater score).
Time frame: 2 months
Young Mania Rating Scale (YMRS) change from week 0
The YMRS is an 11-item clinician-administered cross-sectional rating instrument used to assess the severity of mania in patients with a diagnosis of bipolar disorder. The 11 items are: Elevated Mood, Increased Motor Activity/Energy, Sexual Interest, Sleep, Irritability, Speech (Rate and Amount), Language - Thought Disorder, Content, Disruptive/Aggressive Behaviour, Appearance and Insight. Ratings are based on patient self-reporting, combined with clinician observation (accorded greater score).
Time frame: 3 months
Young Mania Rating Scale (YMRS) change from week 0
The YMRS is an 11-item clinician-administered cross-sectional rating instrument used to assess the severity of mania in patients with a diagnosis of bipolar disorder. The 11 items are: Elevated Mood, Increased Motor Activity/Energy, Sexual Interest, Sleep, Irritability, Speech (Rate and Amount), Language - Thought Disorder, Content, Disruptive/Aggressive Behaviour, Appearance and Insight. Ratings are based on patient self-reporting, combined with clinician observation (accorded greater score).
Time frame: 4 months
Young Mania Rating Scale (YMRS) change from week 0
The YMRS is an 11-item clinician-administered cross-sectional rating instrument used to assess the severity of mania in patients with a diagnosis of bipolar disorder. The 11 items are: Elevated Mood, Increased Motor Activity/Energy, Sexual Interest, Sleep, Irritability, Speech (Rate and Amount), Language - Thought Disorder, Content, Disruptive/Aggressive Behaviour, Appearance and Insight. Ratings are based on patient self-reporting, combined with clinician observation (accorded greater score).
Time frame: 5 months
Young Mania Rating Scale (YMRS) change from week 0
The YMRS is an 11-item clinician-administered cross-sectional rating instrument used to assess the severity of mania in patients with a diagnosis of bipolar disorder. The 11 items are: Elevated Mood, Increased Motor Activity/Energy, Sexual Interest, Sleep, Irritability, Speech (Rate and Amount), Language - Thought Disorder, Content, Disruptive/Aggressive Behaviour, Appearance and Insight. Ratings are based on patient self-reporting, combined with clinician observation (accorded greater score).
Time frame: 6 months
Young Mania Rating Scale (YMRS) change from week 0
The YMRS is an 11-item clinician-administered cross-sectional rating instrument used to assess the severity of mania in patients with a diagnosis of bipolar disorder. The 11 items are: Elevated Mood, Increased Motor Activity/Energy, Sexual Interest, Sleep, Irritability, Speech (Rate and Amount), Language - Thought Disorder, Content, Disruptive/Aggressive Behaviour, Appearance and Insight. Ratings are based on patient self-reporting, combined with clinician observation (accorded greater score).
Time frame: 7 months
Young Mania Rating Scale (YMRS) change from week 0
The YMRS is an 11-item clinician-administered cross-sectional rating instrument used to assess the severity of mania in patients with a diagnosis of bipolar disorder. The 11 items are: Elevated Mood, Increased Motor Activity/Energy, Sexual Interest, Sleep, Irritability, Speech (Rate and Amount), Language - Thought Disorder, Content, Disruptive/Aggressive Behaviour, Appearance and Insight. Ratings are based on patient self-reporting, combined with clinician observation (accorded greater score).
Time frame: 8 months
Young Mania Rating Scale (YMRS) change from week 0
The YMRS is an 11-item clinician-administered cross-sectional rating instrument used to assess the severity of mania in patients with a diagnosis of bipolar disorder. The 11 items are: Elevated Mood, Increased Motor Activity/Energy, Sexual Interest, Sleep, Irritability, Speech (Rate and Amount), Language - Thought Disorder, Content, Disruptive/Aggressive Behaviour, Appearance and Insight. Ratings are based on patient self-reporting, combined with clinician observation (accorded greater score).
Time frame: 9 months
Young Mania Rating Scale (YMRS) change from week 0
The YMRS is an 11-item clinician-administered cross-sectional rating instrument used to assess the severity of mania in patients with a diagnosis of bipolar disorder. The 11 items are: Elevated Mood, Increased Motor Activity/Energy, Sexual Interest, Sleep, Irritability, Speech (Rate and Amount), Language - Thought Disorder, Content, Disruptive/Aggressive Behaviour, Appearance and Insight. Ratings are based on patient self-reporting, combined with clinician observation (accorded greater score).
Time frame: 10 months
Young Mania Rating Scale (YMRS) change from week 0
The YMRS is an 11-item clinician-administered cross-sectional rating instrument used to assess the severity of mania in patients with a diagnosis of bipolar disorder. The 11 items are: Elevated Mood, Increased Motor Activity/Energy, Sexual Interest, Sleep, Irritability, Speech (Rate and Amount), Language - Thought Disorder, Content, Disruptive/Aggressive Behaviour, Appearance and Insight. Ratings are based on patient self-reporting, combined with clinician observation (accorded greater score).
Time frame: 11 months
Young Mania Rating Scale (YMRS) change from week 0
The YMRS is an 11-item clinician-administered cross-sectional rating instrument used to assess the severity of mania in patients with a diagnosis of bipolar disorder. The 11 items are: Elevated Mood, Increased Motor Activity/Energy, Sexual Interest, Sleep, Irritability, Speech (Rate and Amount), Language - Thought Disorder, Content, Disruptive/Aggressive Behaviour, Appearance and Insight. Ratings are based on patient self-reporting, combined with clinician observation (accorded greater score).
Time frame: 12 months
Young Mania Rating Scale (YMRS) change from week 0
The YMRS is an 11-item clinician-administered cross-sectional rating instrument used to assess the severity of mania in patients with a diagnosis of bipolar disorder. The 11 items are: Elevated Mood, Increased Motor Activity/Energy, Sexual Interest, Sleep, Irritability, Speech (Rate and Amount), Language - Thought Disorder, Content, Disruptive/Aggressive Behaviour, Appearance and Insight. Ratings are based on patient self-reporting, combined with clinician observation (accorded greater score).
Time frame: 13 months
Young Mania Rating Scale (YMRS) change from week 0
The YMRS is an 11-item clinician-administered cross-sectional rating instrument used to assess the severity of mania in patients with a diagnosis of bipolar disorder. The 11 items are: Elevated Mood, Increased Motor Activity/Energy, Sexual Interest, Sleep, Irritability, Speech (Rate and Amount), Language - Thought Disorder, Content, Disruptive/Aggressive Behaviour, Appearance and Insight. Ratings are based on patient self-reporting, combined with clinician observation (accorded greater score).
Time frame: 14 months
Young Mania Rating Scale (YMRS) change from week 0
The YMRS is an 11-item clinician-administered cross-sectional rating instrument used to assess the severity of mania in patients with a diagnosis of bipolar disorder. The 11 items are: Elevated Mood, Increased Motor Activity/Energy, Sexual Interest, Sleep, Irritability, Speech (Rate and Amount), Language - Thought Disorder, Content, Disruptive/Aggressive Behaviour, Appearance and Insight. Ratings are based on patient self-reporting, combined with clinician observation (accorded greater score).
Time frame: 15 months
Young Mania Rating Scale (YMRS) change from week 0
The YMRS is an 11-item clinician-administered cross-sectional rating instrument used to assess the severity of mania in patients with a diagnosis of bipolar disorder. The 11 items are: Elevated Mood, Increased Motor Activity/Energy, Sexual Interest, Sleep, Irritability, Speech (Rate and Amount), Language - Thought Disorder, Content, Disruptive/Aggressive Behaviour, Appearance and Insight. Ratings are based on patient self-reporting, combined with clinician observation (accorded greater score).
Time frame: 18 months
Young Mania Rating Scale (YMRS) change from week 0
The YMRS is an 11-item clinician-administered cross-sectional rating instrument used to assess the severity of mania in patients with a diagnosis of bipolar disorder. The 11 items are: Elevated Mood, Increased Motor Activity/Energy, Sexual Interest, Sleep, Irritability, Speech (Rate and Amount), Language - Thought Disorder, Content, Disruptive/Aggressive Behaviour, Appearance and Insight. Ratings are based on patient self-reporting, combined with clinician observation (accorded greater score).
Time frame: 21 months
Young Mania Rating Scale (YMRS) change from week 0
The YMRS is an 11-item clinician-administered cross-sectional rating instrument used to assess the severity of mania in patients with a diagnosis of bipolar disorder. The 11 items are: Elevated Mood, Increased Motor Activity/Energy, Sexual Interest, Sleep, Irritability, Speech (Rate and Amount), Language - Thought Disorder, Content, Disruptive/Aggressive Behaviour, Appearance and Insight. Ratings are based on patient self-reporting, combined with clinician observation (accorded greater score).
Time frame: 24 months
Columbia-Suicide Severity Rating Scale (C-SSRS) change from week 0
The C-SSRS is a semi-structured clinical interview that utilizes a set of prompts and questions to help an interviewer assess the full range of suicidal ideation and behavior, and the intensity of ideation, which helps an interviewer get more complete information on suicide risk.
Time frame: 1 month
Columbia-Suicide Severity Rating Scale (C-SSRS) change from week 0
The C-SSRS is a semi-structured clinical interview that utilizes a set of prompts and questions to help an interviewer assess the full range of suicidal ideation and behavior, and the intensity of ideation, which helps an interviewer get more complete information on suicide risk.
Time frame: 2 months
Columbia-Suicide Severity Rating Scale (C-SSRS) change from week 0
The C-SSRS is a semi-structured clinical interview that utilizes a set of prompts and questions to help an interviewer assess the full range of suicidal ideation and behavior, and the intensity of ideation, which helps an interviewer get more complete information on suicide risk.
Time frame: 3 months
Columbia-Suicide Severity Rating Scale (C-SSRS) change from week 0
The C-SSRS is a semi-structured clinical interview that utilizes a set of prompts and questions to help an interviewer assess the full range of suicidal ideation and behavior, and the intensity of ideation, which helps an interviewer get more complete information on suicide risk.
Time frame: 4 months
Columbia-Suicide Severity Rating Scale (C-SSRS) change from week 0
The C-SSRS is a semi-structured clinical interview that utilizes a set of prompts and questions to help an interviewer assess the full range of suicidal ideation and behavior, and the intensity of ideation, which helps an interviewer get more complete information on suicide risk.
Time frame: 5 months
Columbia-Suicide Severity Rating Scale (C-SSRS) change from week 0
The C-SSRS is a semi-structured clinical interview that utilizes a set of prompts and questions to help an interviewer assess the full range of suicidal ideation and behavior, and the intensity of ideation, which helps an interviewer get more complete information on suicide risk.
Time frame: 6 months
Columbia-Suicide Severity Rating Scale (C-SSRS) change from week 0
The C-SSRS is a semi-structured clinical interview that utilizes a set of prompts and questions to help an interviewer assess the full range of suicidal ideation and behavior, and the intensity of ideation, which helps an interviewer get more complete information on suicide risk.
Time frame: 9 months
Columbia-Suicide Severity Rating Scale (C-SSRS) change from week 0
The C-SSRS is a semi-structured clinical interview that utilizes a set of prompts and questions to help an interviewer assess the full range of suicidal ideation and behavior, and the intensity of ideation, which helps an interviewer get more complete information on suicide risk.
Time frame: 12 months
Columbia-Suicide Severity Rating Scale (C-SSRS) change from week 0
The C-SSRS is a semi-structured clinical interview that utilizes a set of prompts and questions to help an interviewer assess the full range of suicidal ideation and behavior, and the intensity of ideation, which helps an interviewer get more complete information on suicide risk.
Time frame: 15 months
Columbia-Suicide Severity Rating Scale (C-SSRS) change from week 0
The C-SSRS is a semi-structured clinical interview that utilizes a set of prompts and questions to help an interviewer assess the full range of suicidal ideation and behavior, and the intensity of ideation, which helps an interviewer get more complete information on suicide risk.
Time frame: 18 months
Columbia-Suicide Severity Rating Scale (C-SSRS) change from week 0
The C-SSRS is a semi-structured clinical interview that utilizes a set of prompts and questions to help an interviewer assess the full range of suicidal ideation and behavior, and the intensity of ideation, which helps an interviewer get more complete information on suicide risk.
Time frame: 21 months
Columbia-Suicide Severity Rating Scale (C-SSRS) change from week 0
The C-SSRS is a semi-structured clinical interview that utilizes a set of prompts and questions to help an interviewer assess the full range of suicidal ideation and behavior, and the intensity of ideation, which helps an interviewer get more complete information on suicide risk.
Time frame: 24 months
Clinical Global Impression and Improvement Scales (CGI-S and CGI-I) change from week 0
Standardized clinician-administered, cross-sectional assessment of global severity (CGI-S) of PTSD symptomatic status and improvement (CGI-I) from baseline on ordinal 7 point scale.
Time frame: 1 month
Clinical Global Impression and Improvement Scales (CGI-S and CGI-I) change from week 0
Standardized clinician-administered, cross-sectional assessment of global severity (CGI-S) of PTSD symptomatic status and improvement (CGI-I) from baseline on ordinal 7 point scale.
Time frame: 2 months
Clinical Global Impression and Improvement Scales (CGI-S and CGI-I) change from week 0
Standardized clinician-administered, cross-sectional assessment of global severity (CGI-S) of PTSD symptomatic status and improvement (CGI-I) from baseline on ordinal 7 point scale.
Time frame: 3 months
Clinical Global Impression and Improvement Scales (CGI-S and CGI-I) change from week 0
Standardized clinician-administered, cross-sectional assessment of global severity (CGI-S) of PTSD symptomatic status and improvement (CGI-I) from baseline on ordinal 7 point scale.
Time frame: 4 months
Clinical Global Impression and Improvement Scales (CGI-S and CGI-I) change from week 0
Standardized clinician-administered, cross-sectional assessment of global severity (CGI-S) of PTSD symptomatic status and improvement (CGI-I) from baseline on ordinal 7 point scale.
Time frame: 5 months
Clinical Global Impression and Improvement Scales (CGI-S and CGI-I) change from week 0
Standardized clinician-administered, cross-sectional assessment of global severity (CGI-S) of PTSD symptomatic status and improvement (CGI-I) from baseline on ordinal 7 point scale.
Time frame: 6 months
Clinical Global Impression and Improvement Scales (CGI-S and CGI-I) change from week 0
Standardized clinician-administered, cross-sectional assessment of global severity (CGI-S) of PTSD symptomatic status and improvement (CGI-I) from baseline on ordinal 7 point scale.
Time frame: 7 months
Clinical Global Impression and Improvement Scales (CGI-S and CGI-I) change from week 0
Standardized clinician-administered, cross-sectional assessment of global severity (CGI-S) of PTSD symptomatic status and improvement (CGI-I) from baseline on ordinal 7 point scale.
Time frame: 8 months
Clinical Global Impression and Improvement Scales (CGI-S and CGI-I) change from week 0
Standardized clinician-administered, cross-sectional assessment of global severity (CGI-S) of PTSD symptomatic status and improvement (CGI-I) from baseline on ordinal 7 point scale.
Time frame: 9 months
Clinical Global Impression and Improvement Scales (CGI-S and CGI-I) change from week 0
Standardized clinician-administered, cross-sectional assessment of global severity (CGI-S) of PTSD symptomatic status and improvement (CGI-I) from baseline on ordinal 7 point scale.
Time frame: 11 months
Clinical Global Impression and Improvement Scales (CGI-S and CGI-I) change from week 0
Standardized clinician-administered, cross-sectional assessment of global severity (CGI-S) of PTSD symptomatic status and improvement (CGI-I) from baseline on ordinal 7 point scale.
Time frame: 12 months
Clinical Global Impression and Improvement Scales (CGI-S and CGI-I) change from week 0
Standardized clinician-administered, cross-sectional assessment of global severity (CGI-S) of PTSD symptomatic status and improvement (CGI-I) from baseline on ordinal 7 point scale.
Time frame: 13 months
Clinical Global Impression and Improvement Scales (CGI-S and CGI-I) change from week 0
Standardized clinician-administered, cross-sectional assessment of global severity (CGI-S) of PTSD symptomatic status and improvement (CGI-I) from baseline on ordinal 7 point scale.
Time frame: 14 months
Clinical Global Impression and Improvement Scales (CGI-S and CGI-I) change from week 0
Standardized clinician-administered, cross-sectional assessment of global severity (CGI-S) of PTSD symptomatic status and improvement (CGI-I) from baseline on ordinal 7 point scale.
Time frame: 15 months
Clinical Global Impression and Improvement Scales (CGI-S and CGI-I) change from week 0
Standardized clinician-administered, cross-sectional assessment of global severity (CGI-S) of PTSD symptomatic status and improvement (CGI-I) from baseline on ordinal 7 point scale.
Time frame: 18 months
Clinical Global Impression and Improvement Scales (CGI-S and CGI-I) change from week 0
Standardized clinician-administered, cross-sectional assessment of global severity (CGI-S) of PTSD symptomatic status and improvement (CGI-I) from baseline on ordinal 7 point scale.
Time frame: 21 months
Clinical Global Impression and Improvement Scales (CGI-S and CGI-I) change from week 0
Standardized clinician-administered, cross-sectional assessment of global severity (CGI-S) of PTSD symptomatic status and improvement (CGI-I) from baseline on ordinal 7 point scale.
Time frame: 24 months
Veterans Quality of Life Assessment Scale (SF-36v) change from week 0
Standardized, patient-rated cross-sectional scale measuring subjective physical and emotional health across 8 domains: general health (GH), physical function (PF), role limitations due to physical health (RP), bodily pain (BP), mental health (MH), role limitations due to emotional problems (RE), energy/vitality (VT), and social functioning (SF). The RP and RE scales have been modified in the veterans version from yes/no responses to five point ordinal choices. Otherwise the scale is comparable to the Medical Outcomes SF-36 functional assessment scale.
Time frame: 3 months
Veterans Quality of Life Assessment Scale (SF-36v) change from week 0
Standardized, patient-rated cross-sectional scale measuring subjective physical and emotional health across 8 domains: general health (GH), physical function (PF), role limitations due to physical health (RP), bodily pain (BP), mental health (MH), role limitations due to emotional problems (RE), energy/vitality (VT), and social functioning (SF). The RP and RE scales have been modified in the veterans version from yes/no responses to five point ordinal choices. Otherwise the scale is comparable to the Medical Outcomes SF-36 functional assessment scale.
Time frame: 6 months
Veterans Quality of Life Assessment Scale (SF-36v) change from week 0
Standardized, patient-rated cross-sectional scale measuring subjective physical and emotional health across 8 domains: general health (GH), physical function (PF), role limitations due to physical health (RP), bodily pain (BP), mental health (MH), role limitations due to emotional problems (RE), energy/vitality (VT), and social functioning (SF). The RP and RE scales have been modified in the veterans version from yes/no responses to five point ordinal choices. Otherwise the scale is comparable to the Medical Outcomes SF-36 functional assessment scale.
Time frame: 9 months
Veterans Quality of Life Assessment Scale (SF-36v) change from week 0
Standardized, patient-rated cross-sectional scale measuring subjective physical and emotional health across 8 domains: general health (GH), physical function (PF), role limitations due to physical health (RP), bodily pain (BP), mental health (MH), role limitations due to emotional problems (RE), energy/vitality (VT), and social functioning (SF). The RP and RE scales have been modified in the veterans version from yes/no responses to five point ordinal choices. Otherwise the scale is comparable to the Medical Outcomes SF-36 functional assessment scale.
Time frame: 12 months
Veterans Quality of Life Assessment Scale (SF-36v) change from week 0
Standardized, patient-rated cross-sectional scale measuring subjective physical and emotional health across 8 domains: general health (GH), physical function (PF), role limitations due to physical health (RP), bodily pain (BP), mental health (MH), role limitations due to emotional problems (RE), energy/vitality (VT), and social functioning (SF). The RP and RE scales have been modified in the veterans version from yes/no responses to five point ordinal choices. Otherwise the scale is comparable to the Medical Outcomes SF-36 functional assessment scale.
Time frame: 15 months
Veterans Quality of Life Assessment Scale (SF-36v) change from week 0
Standardized, patient-rated cross-sectional scale measuring subjective physical and emotional health across 8 domains: general health (GH), physical function (PF), role limitations due to physical health (RP), bodily pain (BP), mental health (MH), role limitations due to emotional problems (RE), energy/vitality (VT), and social functioning (SF). The RP and RE scales have been modified in the veterans version from yes/no responses to five point ordinal choices. Otherwise the scale is comparable to the Medical Outcomes SF-36 functional assessment scale.
Time frame: 18 months
Veterans Quality of Life Assessment Scale (SF-36v) change from week 0
Standardized, patient-rated cross-sectional scale measuring subjective physical and emotional health across 8 domains: general health (GH), physical function (PF), role limitations due to physical health (RP), bodily pain (BP), mental health (MH), role limitations due to emotional problems (RE), energy/vitality (VT), and social functioning (SF). The RP and RE scales have been modified in the veterans version from yes/no responses to five point ordinal choices. Otherwise the scale is comparable to the Medical Outcomes SF-36 functional assessment scale.
Time frame: 21 months
Veterans Quality of Life Assessment Scale (SF-36v) change from week 0
Standardized, patient-rated cross-sectional scale measuring subjective physical and emotional health across 8 domains: general health (GH), physical function (PF), role limitations due to physical health (RP), bodily pain (BP), mental health (MH), role limitations due to emotional problems (RE), energy/vitality (VT), and social functioning (SF). The RP and RE scales have been modified in the veterans version from yes/no responses to five point ordinal choices. Otherwise the scale is comparable to the Medical Outcomes SF-36 functional assessment scale.
Time frame: 24 months
Davidson Trauma Scale (DTS) change from week 0
The DTS is a 17 item self rated scale with each item corresponding to the 17 DSM-IV-TR symptoms of PTSD. Those 17 items comprise 3 clusters: Intrusive, Avoidance/Numbing, and Hyperarousal. The severity and frequency of each symptom is rated along with the distress associated with those symptoms.
Time frame: 3 months
Davidson Trauma Scale (DTS) change from week 0
The DTS is a 17 item self rated scale with each item corresponding to the 17 DSM-IV-TR symptoms of PTSD. Those 17 items comprise 3 clusters: Intrusive, Avoidance/Numbing, and Hyperarousal. The severity and frequency of each symptom is rated along with the distress associated with those symptoms.
Time frame: 6 months
Davidson Trauma Scale (DTS) change from week 0
The DTS is a 17 item self rated scale with each item corresponding to the 17 DSM-IV-TR symptoms of PTSD. Those 17 items comprise 3 clusters: Intrusive, Avoidance/Numbing, and Hyperarousal. The severity and frequency of each symptom is rated along with the distress associated with those symptoms.
Time frame: 9 months
Davidson Trauma Scale (DTS) change from week 0
The DTS is a 17 item self rated scale with each item corresponding to the 17 DSM-IV-TR symptoms of PTSD. Those 17 items comprise 3 clusters: Intrusive, Avoidance/Numbing, and Hyperarousal. The severity and frequency of each symptom is rated along with the distress associated with those symptoms.
Time frame: 12 months
Davidson Trauma Scale (DTS) change from week 0
The DTS is a 17 item self rated scale with each item corresponding to the 17 DSM-IV-TR symptoms of PTSD. Those 17 items comprise 3 clusters: Intrusive, Avoidance/Numbing, and Hyperarousal. The severity and frequency of each symptom is rated along with the distress associated with those symptoms.
Time frame: 15 months
Davidson Trauma Scale (DTS) change from week 0
The DTS is a 17 item self rated scale with each item corresponding to the 17 DSM-IV-TR symptoms of PTSD. Those 17 items comprise 3 clusters: Intrusive, Avoidance/Numbing, and Hyperarousal. The severity and frequency of each symptom is rated along with the distress associated with those symptoms.
Time frame: 18 months
Davidson Trauma Scale (DTS) change from week 0
The DTS is a 17 item self rated scale with each item corresponding to the 17 DSM-IV-TR symptoms of PTSD. Those 17 items comprise 3 clusters: Intrusive, Avoidance/Numbing, and Hyperarousal. The severity and frequency of each symptom is rated along with the distress associated with those symptoms.
Time frame: 21 months
Davidson Trauma Scale (DTS) change from week 0
The DTS is a 17 item self rated scale with each item corresponding to the 17 DSM-IV-TR symptoms of PTSD. Those 17 items comprise 3 clusters: Intrusive, Avoidance/Numbing, and Hyperarousal. The severity and frequency of each symptom is rated along with the distress associated with those symptoms.
Time frame: 24 months
Global Assessment of Functioning Scale (GAF) change from week 0
Clinician-rated, overall assessment of functional capacity related to psychiatric diagnosis that forms Axis V of DSM-IV TR multiaxial diagnostic assessment. It is designed to rate overall psychological, social and occupational functioning, but does not include any physical or environmental impairments. The patient is rated at the end of a diagnostic interview on a single score scale of 1-100, with the scale being divided into ten ranges of functioning.
Time frame: 3 months
Global Assessment of Functioning Scale (GAF) change from week 0
Clinician-rated, overall assessment of functional capacity related to psychiatric diagnosis that forms Axis V of DSM-IV TR multiaxial diagnostic assessment. It is designed to rate overall psychological, social and occupational functioning, but does not include any physical or environmental impairments. The patient is rated at the end of a diagnostic interview on a single score scale of 1-100, with the scale being divided into ten ranges of functioning.
Time frame: 6 months
Global Assessment of Functioning Scale (GAF) change from week 0
Clinician-rated, overall assessment of functional capacity related to psychiatric diagnosis that forms Axis V of DSM-IV TR multiaxial diagnostic assessment. It is designed to rate overall psychological, social and occupational functioning, but does not include any physical or environmental impairments. The patient is rated at the end of a diagnostic interview on a single score scale of 1-100, with the scale being divided into ten ranges of functioning.
Time frame: 9 months
Global Assessment of Functioning Scale (GAF) change from week 0
Clinician-rated, overall assessment of functional capacity related to psychiatric diagnosis that forms Axis V of DSM-IV TR multiaxial diagnostic assessment. It is designed to rate overall psychological, social and occupational functioning, but does not include any physical or environmental impairments. The patient is rated at the end of a diagnostic interview on a single score scale of 1-100, with the scale being divided into ten ranges of functioning.
Time frame: 12 months
Global Assessment of Functioning Scale (GAF) change from week 0
Clinician-rated, overall assessment of functional capacity related to psychiatric diagnosis that forms Axis V of DSM-IV TR multiaxial diagnostic assessment. It is designed to rate overall psychological, social and occupational functioning, but does not include any physical or environmental impairments. The patient is rated at the end of a diagnostic interview on a single score scale of 1-100, with the scale being divided into ten ranges of functioning.
Time frame: 15 months
Global Assessment of Functioning Scale (GAF) change from week 0
Clinician-rated, overall assessment of functional capacity related to psychiatric diagnosis that forms Axis V of DSM-IV TR multiaxial diagnostic assessment. It is designed to rate overall psychological, social and occupational functioning, but does not include any physical or environmental impairments. The patient is rated at the end of a diagnostic interview on a single score scale of 1-100, with the scale being divided into ten ranges of functioning.
Time frame: 18 months
Global Assessment of Functioning Scale (GAF) change from week 0
Clinician-rated, overall assessment of functional capacity related to psychiatric diagnosis that forms Axis V of DSM-IV TR multiaxial diagnostic assessment. It is designed to rate overall psychological, social and occupational functioning, but does not include any physical or environmental impairments. The patient is rated at the end of a diagnostic interview on a single score scale of 1-100, with the scale being divided into ten ranges of functioning.
Time frame: 21 months
Global Assessment of Functioning Scale (GAF) change from week 0
Clinician-rated, overall assessment of functional capacity related to psychiatric diagnosis that forms Axis V of DSM-IV TR multiaxial diagnostic assessment. It is designed to rate overall psychological, social and occupational functioning, but does not include any physical or environmental impairments. The patient is rated at the end of a diagnostic interview on a single score scale of 1-100, with the scale being divided into ten ranges of functioning.
Time frame: 24 months
Wechsler Adult Intelligence Scale III (WAIS-III)-Digit Span Subtest change from baseline
Standardized, two-part test of working memory consisting of digits forward, which measures subjects ability to repeat sequences of 3 to 9 digits; and digits backward in which subjects are asked to repeat two to eight numbers in reverse order.
Time frame: 6 months
Wechsler Adult Intelligence Scale III (WAIS-III)-Digit Span Subtest change from baseline
Standardized, two-part test of working memory consisting of digits forward, which measures subjects ability to repeat sequences of 3 to 9 digits; and digits backward in which subjects are asked to repeat two to eight numbers in reverse order.
Time frame: 24 months
Controlled Oral Word Association Test (COWAT) change from baseline
This test is a brief and sensitive measure of verbal association fluency and executive cognitive dysfunction. It measures the spontaneous production of words beginning with a given letter (phonetic association) or given class of words (semantic association) and the subjects are asked to produce as many words as possible within the time limits. F, A and S are the most commonly used letters and a common category is animals. Administration takes approximately 5-10 minutes.
Time frame: 6 months
Controlled Oral Word Association Test (COWAT) change from baseline
This test is a brief and sensitive measure of verbal association fluency and executive cognitive dysfunction. It measures the spontaneous production of words beginning with a given letter (phonetic association) or given class of words (semantic association) and the subjects are asked to produce as many words as possible within the time limits. F, A and S are the most commonly used letters and a common category is animals. Administration takes approximately 5-10 minutes.
Time frame: 24 months
The Clinician-Administered PTSD scale (CAPS) change from week 0
This is a standardized structured, clinician administered interview that includes both questions confirming the diagnosis of PTSD (CAPSDx) as well as symptom severity over specified time periods (lifetime, past week or past month) based on the 17 symptoms of PTSD in DSM-III/II-R and IV across clusters of recurrence, avoidance/numbing and hyper-arousal symptoms (CAPS1-17 or CAPSSx).
Time frame: 12 months
Clinical Global Impression and Improvement Scales (CGI-S and CGI-I) change from week 0
Standardized clinician-administered, cross-sectional assessment of global severity (CGI-S) of PTSD symptomatic status and improvement (CGI-I) from baseline on ordinal 7 point scale.
Time frame: 10 months
Ruff Figural Fluency Test (RFFT) change from baseline
This test measures the production of novel designs under time constraints and is intended to assess the capacity for fluid and divergent thinking, flexibility in shifting thinking, planning strategies and the ability to coordinate a process. Five dot stimuli are presented in 35 contiguous squares and subjects are asked to draw as many unique designs as possible by connecting the dots within each rectangle.
Time frame: 6 months
Ruff Figural Fluency Test (RFFT) change from baseline
This test measures the production of novel designs under time constraints and is intended to assess the capacity for fluid and divergent thinking, flexibility in shifting thinking, planning strategies and the ability to coordinate a process. Five dot stimuli are presented in 35 contiguous squares and subjects are asked to draw as many unique designs as possible by connecting the dots within each rectangle.
Time frame: 24 months
Hopkins Verbal Learning Test - Revised (HVLT-R) change from baseline
This test assesses immediate and delayed recall along with delayed recognition. The subject is provided 3 learning trials to remember an orally presented 12-word list (four nouns from each of 3 semantic categories). Following a 20-25 minute interval, delayed recall and yes/no recognition are assessed. The yes/no recognition is where subjects are also asked to identify the words from a word list (12 target words and 12 non-target words) that is presented verbally. The test takes about 15 minutes excluding the delay interval which is preferably filled with intervening visuospatial tasks. Administration time is approximately 5-10 minutes excluding the 25 minute delay.
Time frame: 6 months
Hopkins Verbal Learning Test - Revised (HVLT-R) change from baseline
This test assesses immediate and delayed recall along with delayed recognition. The subject is provided 3 learning trials to remember an orally presented 12-word list (four nouns from each of 3 semantic categories). Following a 20-25 minute interval, delayed recall and yes/no recognition are assessed. The yes/no recognition is where subjects are also asked to identify the words from a word list (12 target words and 12 non-target words) that is presented verbally. The test takes about 15 minutes excluding the delay interval which is preferably filled with intervening visuospatial tasks. Administration time is approximately 5-10 minutes excluding the 25 minute delay.
Time frame: 24 months
Brief Visual Memory Test - Revised (BVMT-R) change from baseline
This test is used to assess visual memory and consists of six alternate forms that give measures of recognition, rate of acquisition, immediate recall, and delayed recall. For 10 seconds, a subject is given a stimulus form consisting of six geometric figures in a 2 x 3 matrix. The tasks consist of immediately drawing as many of the figures as possible in their correct location and this task is repeated 25 minutes later. This is followed by a recognition trial in which the subject is asked to identify which six of the 12 presented figures were on the original form. About 15 minutes are required for the test, excluding the delay interval.
Time frame: 6 months
Brief Visual Memory Test - Revised (BVMT-R) change from baseline
This test is used to assess visual memory and consists of six alternate forms that give measures of recognition, rate of acquisition, immediate recall, and delayed recall. For 10 seconds, a subject is given a stimulus form consisting of six geometric figures in a 2 x 3 matrix. The tasks consist of immediately drawing as many of the figures as possible in their correct location and this task is repeated 25 minutes later. This is followed by a recognition trial in which the subject is asked to identify which six of the 12 presented figures were on the original form. About 15 minutes are required for the test, excluding the delay interval.
Time frame: 24 months
Boston Naming Test (BNT) change from baseline
The BNT assesses the ability to name pictured objects with 60 line drawings that are presented one at a time. Words range from common (tree) to low frequency/rare (abacus). Scores include number correct and the need for various types of cueing as two prompting cues are allowed (phonemic cue, stimulus cue). Scores can be compared with age-based norms. This test requires approximately 10-20 minutes.
Time frame: 6 months
Boston Naming Test (BNT) change from baseline
The BNT assesses the ability to name pictured objects with 60 line drawings that are presented one at a time. Words range from common (tree) to low frequency/rare (abacus). Scores include number correct and the need for various types of cueing as two prompting cues are allowed (phonemic cue, stimulus cue). Scores can be compared with age-based norms. This test requires approximately 10-20 minutes.
Time frame: 24 months
Hooper Visual Organization Test (VOT) change from baseline
This tests the ability of the subject to conceptually organize visual stimuli (pictures) that have been disarranged and allows the assessor to detect neurological impairment. The test consists of 30 line drawings of common objects that have been cut into pieces. These pieces are scattered and the task is to identify what the object would be if the pieces were put back correctly. Total test time is approximately 10-15 minutes.
Time frame: 6 months
Hooper Visual Organization Test (VOT) change from baseline
This tests the ability of the subject to conceptually organize visual stimuli (pictures) that have been disarranged and allows the assessor to detect neurological impairment. The test consists of 30 line drawings of common objects that have been cut into pieces. These pieces are scattered and the task is to identify what the object would be if the pieces were put back correctly. Total test time is approximately 10-15 minutes.
Time frame: 24 months
Rey-Osterrieth Complex Figure (CFT) change from baseline
The purpose of this test is to assess visuospatial perception, attention, planning, and visual and working memory, by the construction of a complex figure and then remembering it for later recall (3 minutes and a 30 minute delayed recall). Total test time is approximately 10-15 minutes, excluding the delay.
Time frame: 6 months
Rey-Osterrieth Complex Figure (CFT) change from baseline
The purpose of this test is to assess visuospatial perception, attention, planning, and visual and working memory, by the construction of a complex figure and then remembering it for later recall (3 minutes and a 30 minute delayed recall). Total test time is approximately 10-15 minutes, excluding the delay.
Time frame: 24 months
Clock Drawing Test change from baseline
This is a screening test for visuospatial and cognitive dysfunction. The subject is given an unlined sheet of paper and asked to construct a clock containing all the numbers and with the hands set to a specified time. Abnormal drawings can be a result of psychiatric conditions as well as other medical conditions. This test can be completed in about 5 minutes. Several standardized, quantitative scoring systems exist.
Time frame: 6 months
Clock Drawing Test change from baseline
This is a screening test for visuospatial and cognitive dysfunction. The subject is given an unlined sheet of paper and asked to construct a clock containing all the numbers and with the hands set to a specified time. Abnormal drawings can be a result of psychiatric conditions as well as other medical conditions. This test can be completed in about 5 minutes. Several standardized, quantitative scoring systems exist.
Time frame: 24 months
Wisconsin Card Sorting Test (WCST) change from baseline
This test measures the ability to form concepts, utilize feedback and "set-shift", which is the ability to display flexibility in the face of changing conditions. Four stimulus cards are placed in front of the subject who then is given two packs of response cards with 64 cards in each set. No instructions are given as to how to match the response cards to the stimulus - by color, design or quantity of symbols. Feedback is given each time a correct or incorrect selection is made. During the test the matching rules are altered and the subject must adjust by learning the new rules. The approximate time to complete this test is 15-30 minutes. Assesses dorsolateral prefrontal-subcortical circuit function
Time frame: 6 months
Wisconsin Card Sorting Test (WCST) change from baseline
This test measures the ability to form concepts, utilize feedback and "set-shift", which is the ability to display flexibility in the face of changing conditions. Four stimulus cards are placed in front of the subject who then is given two packs of response cards with 64 cards in each set. No instructions are given as to how to match the response cards to the stimulus - by color, design or quantity of symbols. Feedback is given each time a correct or incorrect selection is made. During the test the matching rules are altered and the subject must adjust by learning the new rules. The approximate time to complete this test is 15-30 minutes. Assesses dorsolateral prefrontal-subcortical circuit function
Time frame: 24 months
Stroop Color and Word Test (STROOP) change from baseline
This test is a measure of reaction time, selective attention, cognitive flexibility in terms of shifting perception to changing demands, and the ability to suppress a habitual response in favor of an unusual one. It is based upon the fact that we can read words faster than we can name colors. There are 3 parts to the test. In Part 1 (Color Reading), the subject has to read the word of the colors, (red, green, blue) which are printed either in black ink or in the color that corresponds to the printed word. In the Part 2 (Color Naming), the print color of the words does not correspond to the color name and the subject must name the printed word. In Part 3, the subject must name the color in which the color names are printed and disregard reading the word. An increased interference effect can occur in a variety of disorders which include mental disease. The entire test can be completed in about 5 minutes. Assesses dorsolateral prefrontal-subcortical circuit function
Time frame: 6 months
Stroop Color and Word Test (STROOP) change from baseline
This test is a measure of reaction time, selective attention, cognitive flexibility in terms of shifting perception to changing demands, and the ability to suppress a habitual response in favor of an unusual one. It is based upon the fact that we can read words faster than we can name colors. There are 3 parts to the test. In Part 1 (Color Reading), the subject has to read the word of the colors, (red, green, blue) which are printed either in black ink or in the color that corresponds to the printed word. In the Part 2 (Color Naming), the print color of the words does not correspond to the color name and the subject must name the printed word. In Part 3, the subject must name the color in which the color names are printed and disregard reading the word. An increased interference effect can occur in a variety of disorders which include mental disease. The entire test can be completed in about 5 minutes. Assesses dorsolateral prefrontal-subcortical circuit function
Time frame: 24 months
Iowa Gambling Task (IGT) change from baseline
This test simulates a real-life decision-making situation and assesses the subjects decision making under ambiguity as well as classifying the subjects decision-making behavior in terms of risk taking and risk aversion. Subjects are given 4 card decks with the goal of maximizing winnings. They are told that sometimes they will win and sometimes they will lose but they are not informed that 2 of the decks are "risky" because they are associated with large wins, but also large losses. It has been found that subjects with orbitofrontal cortex dysfunction continue to persevere with the risky decks.
Time frame: 6 months
Iowa Gambling Task (IGT) change from baseline
This test simulates a real-life decision-making situation and assesses the subjects decision making under ambiguity as well as classifying the subjects decision-making behavior in terms of risk taking and risk aversion. Subjects are given 4 card decks with the goal of maximizing winnings. They are told that sometimes they will win and sometimes they will lose but they are not informed that 2 of the decks are "risky" because they are associated with large wins, but also large losses. It has been found that subjects with orbitofrontal cortex dysfunction continue to persevere with the risky decks.
Time frame: 24 months
Mini Mental State Exam (MMSE) change from baseline
The purpose of this test is to provide a rapid "bedside" grade of severity of cognitive impairment. Over the course of approximately 10 minutes, it samples orientation, memory, concentration, language and visuospatial function via simple questions and problems. The maximum score is 30 and any score \> 25 is considered to be normal functioning.
Time frame: 6 months
Mini Mental State Exam (MMSE) change from baseline
The purpose of this test is to provide a rapid "bedside" grade of severity of cognitive impairment. Over the course of approximately 10 minutes, it samples orientation, memory, concentration, language and visuospatial function via simple questions and problems. The maximum score is 30 and any score \> 25 is considered to be normal functioning.
Time frame: 24 months
Change in PET CT 18-fluorodeoxyglucose metabolism from baseline
Pre-operatively, patients will undergo a provocative PET CT scan using fluorodeoxyglucose (FDG) assessing activity of the amygdalae, insulae and medial PFC regions. The provocation will consist of re-exposure of the patient to the initial trauma that caused PTSD using script-driven imagery as in prolonged exposure therapy. Baseline and 15 month scans will be compared both for resting and post-provocation metabolism. The hypothesis is that DBS reduces amygdala hyperactivity in PTSD patients. The PET CT scan data will be processed with a statistical parametric mapping method using SPM99 (Wellcome Department of Neurology, London, England). PET data in each voxel will be normalized and fitted in a linear statistical model. Hypotheses will be evaluated as contrasts where the linear compounds of the model parameters will be evaluated with t-tests transformed into a z-score. We will consider z\>3.09 (P\<0.001 one tail, uncorrected) as statistically significant.
Time frame: 15 months