Long Term Follow Up KET-PD

N/AEnrolling By InvitationNCT06164756

Yale University40 enrolled

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Parkinson's Disease Depression

Interventions

Cognitive Behavior Therapy (CBT)OTHER

Participants will receive 10 weeks of CBT

Treatment As Usual (TAU)OTHER

Participants will receive standard of care treatment

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

Eligibility is determined in the ongoing parent clinical trial (KET-PD trial; NCT04944017, HIC 2000030394).

Locations (1)

Yale New Haven Hospital

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

Long-Term Change in Depression Severity

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.