The proposed investigation will determine the therapeutic potential of aripiprazole augmentation to a stable antidepressant regimen for reducing posttraumatic stress disorder (PTSD) symptoms, cognitive symptoms, psychotic symptoms, and depressive symptoms in veterans with PTSD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
14
Aripiprazole: 5 mg taken once a day orally for 2 weeks, then Aripiprazole: 5-10 mg taken once a day orally for 2 weeks, then Aripiprazole: 5-15 mg taken once a day orally for 2 weeks, then Aripiprazole: 5-20 mg taken once a day orally for 2 weeks
Same as active drug.
Durham VAMC 508 Fulton Street
Durham, North Carolina, United States
Clinician Administered PTSD Scale (CAPS)
Mean change scores (Week 2 minus Week 6) in posttraumatic stress disorder symptoms. Scores may range from 0 (no symptoms) to 136 (severe symptoms; score of 136 is based on the first 17 CAPS items administered). A reduced CAPS score indicates a reduction in (improvement) PTSD symptoms, while an increase in CAPS score indicates an increase (worsening) in PTSD symptoms.
Time frame: Week 2 and Week 6
Brief Assessment of Cognition in Affective Disorders (BAC-A)
The BACS includes brief assessments of executive functions, verbal fluency, attention, verbal memory, working memory and motor speed. Z-scores are calculated from composite scores. Higher z-scores are indicative of better cognitive performance, lower z-scores are indicative of lower cognitive performance. Range of z-scores anticipated to be between -3 and 3. Mean change scores from week 2 and week 6 (Week 2 minus Week 6).
Time frame: Week 2 and Week 6
Positive and Negative Symptoms Scale (PANSS)
The PANSS is a widely used measure with several subdomains, including positive symptoms, negative symptoms, and general psychopathology of schizophrenia. Lower scores are indicative of fewer symptoms; higher scores are indicative of more symptoms. Total PANSS scores range from 0-20.Mean change scores from Week 2 and Week 6 (Week 2 minus Week 6)
Time frame: Week 2 and Week 6
Connor-Davidson Resilience Scale (CD-RISC)
This scale measures resilience. Range of scores (0-100). A score of 0 is suggestive of no resilience, a score of 100 is suggestive of high level of resilience. Change scores calculated at Week 2 and Week 6 (Week 2 minus Week 6).
Time frame: Week 2 and Week 6
Beck Depression Inventory, Second Edition (BDI-II)
The Beck Depression Inventory-II (BDI) is a very sensitive and widely used instrument used to detect depressive symptoms. It consists of 21 items that assess the intensity of depression in both clinical and non-clinical subjects. Each item is a list of four statements arranged in increasing severity regarding a particular symptom of depression. Scores range from 0 to 63 (higher scores suggest higher levels of depression). Change scores were calculated from Week 2 and Week 6 scores (Week 2 minus Week 6).
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Time frame: Week 2 and Week 6