Long-Term Follow-Up for Subjects Enrolled in the Ketamine for the Treatment of Depression in Parkinson's Disease (KET-PD) Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Parkinson's Disease
- Sponsor
- Yale University
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Long-Term Change in Depression Severity
- Status
- Enrolling By Invitation
- Last Updated
- 9 months ago
Overview
Brief Summary
The purpose of this study is to examine a) the longer-term effects of ketamine for treating depression in Parkinson's disease (PD) and b) the effects of CBT on maintaining the effects of ketamine.
Detailed Description
This is a roll-out study from the ongoing clinical trial (KET-PD trial; NCT04944017, HIC 2000030394). We will adopt an implementation science approach to have participants across ketamine and placebo groups in one of two arms: a) follow-up with treatment as usual (TAU) (at 3 and 6 months post-infusions); b) follow-up with 3 months of Cognitive Behavior Therapy (CBT) post-infusions, delivered remotely once per week, with follow-up assessments at 3 and 6 month timepoints. CBT is expected to have a superior sustained antidepressant response to the TAU follow-up group in both ketamine and placebo arms. We hypothesize that ketamine + CBT will show the most superior antidepressant response at follow-up.
Investigators
Sophie Holmes
Assistant Professor of Psychiatry
Yale University
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Long-Term Change in Depression Severity
Time Frame: 3 Months and 6 Months
Change in MADRS score following course of ketamine vs. placebo treatment at 3 and 6 month timepoints; and change in MADRS across treatment (ketamine/placebo) and follow-up (CBT/TAU) arms at 3 and 6 month timepoints. The scale used to measure depression severity is called The Montgomery-Åsberg Depression Rating Scale (MADRS). The MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. The overall score ranges from 0 to 60, higher MADRS score indicates more severe depression.
Secondary Outcomes
- Change in Dyskinesia(3 Months and 6 Months)
- Change in Fatigue(3 Months and 6 Months)
- Change in Anxiety(3 Months and 6 Months)
- Change in Pain(3 Months and 6 Months)
- Change in Apathy(3 Months and 6 Months)
- Change in Anhedonia(3 Months and 6 Months)
- Change in Parkinson's Symptom Severity(3 Months and 6 Months)