Parkinson's disease (PD) is a devastating illness that has a growing impact on Veterans. One of the most disabling symptoms is depression, which is common in PD and linked to poor quality of life and higher risk of suicide. Unfortunately, there is a lack of effective treatments for depression in PD. Ketamine, which has rapid and potent antidepressant effects, is a potential option but has not been tested in Veterans with PD. Studies in rodents show that ketamine may not only improve depression in PD, it may target two of the underlying drivers of the disease: (1) reduced neuroplasticity, or the brain's ability to adapt and remodel itself; and (2) elevated inflammation. The investigators are conducting a randomized, placebo-controlled study to examine if a dose of intravenous (IV) ketamine improves depression in Veterans with PD. The investigators will also examine ketamine's effects on neuroplasticity and inflammation, which will help us understand how ketamine works in PD and if it can be a useful treatment for Veterans with the disease. This study will lay groundwork for a larger clinical trial across multiple VA sites.
This is a double-masked, active placebo-controlled, single dose randomized trial of intravenous (IV) ketamine versus remimazolam for depression in Veterans (N=80) with Parkinson's disease (PD). The investigators hypothesize that ketamine will have a strong safety and tolerability profile and improve depressive symptoms within 24 hours (Aim 1). Further, its antidepressant effects will be associated with modulation of both impaired neuroplasticity (Aim 2) and elevated inflammatory activity (Aim 3). To test these hypotheses, the investigators will use clinical assessments (of adverse events, tolerability, and depression), non-invasive brain stimulation techniques to quantify changes in LTP-like neuroplasticity, and blood-based cytokine measurement to quantify changes in systemic inflammation. This study will provide clinical efficacy data and elucidate ketamine's mechanisms of action in PD using accessible, neuroscience-informed markers of neuroplasticity and inflammation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
80
intravenous ketamine infusion 0.5 mg/kg
intravenous remimazolam infusion 0.03 mg/kg
San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, United States
RECRUITINGMontgomery-Asberg Depression Rating Scale (MADRS)
Changes in depression as measured by the Montgomery-Asberg Depression Rating Scale (MADRS) between baseline and 24 hours post-infusion. Overall score ranges from 0 to 60, where higher scores indicate more severe depression
Time frame: baseline and 24 hours post-infusion.
Montgomery-Asberg Depression Rating Scale (MADRS)
Changes in depression severity as measured by Montgomery-Asberg Depression Rating Scale scores. Overall score ranges from 0 to 60, where higher scores indicate more severe depression
Time frame: Baseline to 24 hours post-infusion, Day 3, Day 5, Day 7
Hamilton Depression Rating Scale-7 (HAMD-7)
Changes in core depressive symptoms as measured by the Hamilton Depression Rating Scale-7. Overall score ranges from 0 to 56, where higher scores indicate more severe depression
Time frame: Baseline to 24 hours post-infusion, Day 3, Day 5, Day 7
Patient- Reported Outcomes Measurement Information System (PROMIS®)
Changes in functional impairment related to PD as measured by the Patient- Reported Outcomes Measurement Information System (PROMIS®), where higher scores indicate more impairment
Time frame: Baseline to Day 7
Quality of Life in Neurological Disorders (Neuro-QoLTM)
Changes in quality of life measured by select measures on the Quality of Life in Neurological Disorders (Neuro-QoLTM), where higher scores indicate more impairment
Time frame: Baseline to Day 7
Incidence, severity, and frequency of Adverse Events (AEs) including Treatment- Emergent AEs (TEAEs) and Serious AEs (SAEs)
Incidence, severity, and frequency of Adverse Events (AEs) including Treatment- Emergent AEs (TEAEs) and Serious AEs (SAEs)
Time frame: Baseline to Day 7
Ketamine Side Effect Tool (KSET)
Incidence, severity and frequency of AEs using a study-specific adaptation of the Ketamine Side Effect Tool (KSET)
Time frame: Baseline to Day 7
Enhanced Scale for the Assessment of Positive Symptoms for Parkinson's Disease (eSAPS- PD)
Changes in clinician-rated psychotic symptoms assessed using the Enhanced Scale for the Assessment of Positive Symptoms for Parkinson's Disease (eSAPS- PD). Scores range from 25 to 125, where higher scores indicate more impairment
Time frame: Baseline to Day 7
Frequency, Intensity, Burden of Side Effects Rating Scale (FIBSER)
Tolerability as assessed by the Frequency, Intensity, Burden of Side Effects Rating Scale (FIBSER). Scores range from 0-6, where higher scores indicate more impairment
Time frame: Day 7
Hamilton Anxiety Rating Scale (HAM-A)
Changes in anxiety as measured by the Hamilton Anxiety Rating Scale (HAM-A); Overall score ranges from 0 to 56, where higher scores indicate more severe anxiety
Time frame: Baseline to 24 hours post-infusion, Day3, Day 7
Movement Disorder Society revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Changes in PD symptom severity measured by the Movement Disorder Society revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Time frame: Baseline to 4 hours post-infusion, 24 hours post-infusion, Day 3, Day 5, Day 7
transcranial magnetic stimulation (TMS)
Changes in brain structure as measured by transcranial magnetic stimulation (TMS)
Time frame: Baseline to 4 hours post-infusion
Changes in inflammatory index as measured by blood-based analysis
Changes in inflammatory index as measured by blood-based analysis
Time frame: Baseline to 4 hours post-infusion
transcranial magnetic stimulation (TMS)
Changes in brain function as measured by transcranial magnetic stimulation (TMS)
Time frame: Baseline to 4 hours post-infusion
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