Long-Term Follow-Up for Subjects Enrolled in the Ketamine for the Treatment of Depression in Parkinson's Disease (KET-PD) Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Yale University
- Enrollment
- 49
- Locations
- 2
- Primary Endpoint
- Long-Term Change in Depression Severity
Study 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 40 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Eligibility is determined in the ongoing parent clinical trial (KET-PD trial; NCT04944017, HIC 2000030394).
Exclusion Criteria
- Not provided
Arms & Interventions
Experimental: Ketamine Infusion
Participants who received 6 infusions of ketamine (0.5 mg/kg IV, up to 60 mg total), administered over 40 minutes while on continuous cardiac monitoring and oximetry in the ongoing clinical trial (KET-PD trial; NCT04944017, HIC 2000030394)
Intervention: Cognitive Behavior Therapy (CBT) (Other)
Placebo Comparator: Saline Infusion
Participants who received 6 infusions of placebo (saline IV), administered over 40 minutes while on continuous cardiac monitoring and oximetry in the ongoing clinical trial (KET-PD trial; NCT04944017, HIC 2000030394)
Intervention: Cognitive Behavior Therapy (CBT) (Other)
Experimental: Ketamine Infusion
Participants who received 6 infusions of ketamine (0.5 mg/kg IV, up to 60 mg total), administered over 40 minutes while on continuous cardiac monitoring and oximetry in the ongoing clinical trial (KET-PD trial; NCT04944017, HIC 2000030394)
Intervention: Treatment As Usual (TAU) (Other)
Placebo Comparator: Saline Infusion
Participants who received 6 infusions of placebo (saline IV), administered over 40 minutes while on continuous cardiac monitoring and oximetry in the ongoing clinical trial (KET-PD trial; NCT04944017, HIC 2000030394)
Intervention: Treatment As Usual (TAU) (Other)
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 Anxiety(3 Months and 6 Months)
- Change in Dyskinesia(3 Months and 6 Months)
- Change in Fatigue(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)
Investigators
Study Sites (2)
Identifiers
- NCT ID
- NCT06164756
- Other Study IDs
- 2000036071
Dates
- First Submitted
- (2 years ago)
- First Posted
- (2 years ago)
- Primary Completion
- (6 months ago)
- Study Completion
- (6 months ago)
- Last Verified
- (29 days ago)
- Last updated
- (2 days ago)
Regulatory & Sharing
- FDA Regulated Drug
- No
- FDA Regulated Device
- No
- IPD Sharing Plan
- No
- Has Results
- No