Long Term Follow Up KET-PD

• Conditions: Parkinson's Disease; Depression
• Interventions: Other: Cognitive Behavior Therapy (CBT); Other: Treatment As Usual (TAU)

• Registration Number: NCT06164756
• Lead Sponsor: Yale University

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 Timeline

• Study Start: 2023-10-18
• Study First Submitted: 2023-12-01
• Study First Submitted QC: 2023-12-01
• Study First Posted: 2023-12-11
• Status Verified: 2024-10
• Last Update Submitted: 2024-11-08
• Last Update Posted: 2024-11-12
• Primary Completion: 2025-02
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Experimental: Ketamine Infusion	Cognitive Behavior Therapy (CBT)	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)
Experimental: Ketamine Infusion	Treatment As Usual (TAU)	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)
Placebo Comparator: Saline Infusion	Treatment As Usual (TAU)	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)
Placebo Comparator: Saline Infusion	Cognitive Behavior Therapy (CBT)	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)

Primary Outcome Measures

Name	Time	Method
Long-Term Change in Depression Severity	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 Outcome Measures

Name	Time	Method
Change in Dyskinesia	3 Months and 6 Months	Changes in dyskinesia determined by the Unified Dyskinesia Rating Scale (UDysRS) scale
Change in Fatigue	3 Months and 6 Months	Changes in fatigue determined by the Parkinson's Fatigue Scale (PFS)
Change in Anxiety	3 Months and 6 Months	Changes in anxiety determined by the State-Trait Anxiety Inventory (STAI) scale
Change in Pain	3 Months and 6 Months	Changes in pain determined by the King's PD Pain Scale
Change in Apathy	3 Months and 6 Months	Changes in apathy determined by the Starkstein Apathy Scale (SAS) scale
Change in Anhedonia	3 Months and 6 Months	Changes in anhedonia determined by the Snaith-Hamilton Pleasure Scale (SHAPS)
Change in Parkinson's Symptom Severity	3 Months and 6 Months	Changes in Parkinson's symptom severity determined by the Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) scale

Trial Locations

Locations (1)

Yale New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States