Long Term Follow Up KET-PD

This observational cohort study (n=40), conducted by Yale University, aims to explore the long-term effects of ketamine for treating depression in Parkinson’s disease (PD) and assess the impact of Cognitive Behaviour Therapy (CBT) on maintaining the effects of ketamine.

The study is a roll-out from the ongoing KET-PD trial (NCT04944017, HIC 2000030394). Participants across ketamine and placebo groups will be divided into two arms: one receiving treatment as usual (TAU) and the other receiving 3 months of CBT post-infusions. CBT is expected to yield a superior sustained antidepressant response compared to the TAU group in both ketamine and placebo arms. The study hypothesizes that the combination of ketamine and CBT will demonstrate the most superior antidepressant response during follow-up.

The trial commenced on October 18, 2023, with an estimated completion date of December 2025. It aims to enrol 40 participants and will evaluate the long-term change in depression severity using the Montgomery-Åsberg Depression Rating Scale (MADRS) at 3 and 6-month intervals.

Secondary outcome measures include changes in apathy, anxiety, Parkinson’s symptom severity, dyskinesia, pain, fatigue, and anhedonia. Recruitment is being conducted at Yale New Haven Hospital in Connecticut, United States, with participants aged between 40 and 80 years with PD and comorbid depression.

Topic Depression Neurocognitive Disorders
Compound Ketamine Placebo
Country United States of America
Visit trial
Status Enrolling by invitation
Results Published No
Start date 18 October 2023
End date 31 December 2025
Phase Not Applicable
Design Open
Type Observational
Generation First
Participants 40
Sex All
Age 40- 80
Therapy Yes

Trial Details

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.

Trial Number NCT06164756

Sponsors & Collaborators

Yale University
The Yale Psychedelic Science Group was established in 2016.

Data attribution

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