NCT06164756

Long Term Follow Up KET-PD

Long-Term Follow-Up for Subjects Enrolled in the Ketamine for the Treatment of Depression in Parkinson's Disease (KET-PD) Trial

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Parkinson's Disease
• Depression

Interventions

Type	Name	Description
OTHER	Cognitive Behavior Therapy (CBT)	Participants will receive 10 weeks of CBT
OTHER	Treatment As Usual (TAU)	Participants will receive standard of care treatment

Timeline

• Start date: 2023-10-18
• Primary completion: 2025-12-21
• Completion: 2025-12-21
• First posted: 2023-12-11
• Last updated: 2025-07-11

Locations

1 site across 1 country: United States