Long Term Follow Up KET-PD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cognitive Behavior Therapy (CBT), Treatment As Usual (TAU).
- Who it may be relevant to
- Registry conditions: Parkinson's Disease, Depression. Basic parameters: 40 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Long-Term Follow-Up for Subjects Enrolled in the Ketamine for the Treatment of Depression in Parkinson's Disease (KET-PD) Trial
Overview
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.
Interventions
- Other Cognitive Behavior Therapy (CBT)
Participants will receive 10 weeks of CBT - Other Treatment As Usual (TAU)
Participants will receive standard of care treatment
Primary outcome measures
- Long-Term Change in Depression Severity [Time frame: 3 Months and 6 Months]
Secondary outcome measures (7)
- Change in Apathy [Time frame: 3 Months and 6 Months]
- Change in Anxiety [Time frame: 3 Months and 6 Months]
- Change in Parkinson's Symptom Severity [Time frame: 3 Months and 6 Months]
- Change in Dyskinesia [Time frame: 3 Months and 6 Months]
- Change in Pain [Time frame: 3 Months and 6 Months]
- Change in Fatigue [Time frame: 3 Months and 6 Months]
- Change in Anhedonia [Time frame: 3 Months and 6 Months]
Eligibility criteria
Eligibility is determined in the ongoing parent clinical trial (KET-PD trial; NCT04944017, HIC 2000030394).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Yale New Haven Hospital — New Haven
Identifiers
NCT: NCT06164756 · 2000036071