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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Depression; Parkinson's Disease
• Intervention / Treatment: Other: Cognitive Behavior Therapy (CBT); Other: Treatment As Usual (TAU)

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 Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale New Haven Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

A total of n=56 participants with PD and comorbid depression, age 40-80, are being recruited under the parent clinical trial. As of July 2023, 20 participants have been enrolled. We aim to follow-up our remaining participants longitudinally and, within this, to have 20 prospective participants receive CBT, such that we will have 20 participants in each follow-up arm (CBT vs. TAU), and ultimately 10 in each group (ketamine + CBT, ketamine + TAU, placebo + CBT, placebo + TAU).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Experimental: Ketamine Infusion; 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)	Other: Cognitive Behavior Therapy (CBT); Participants will receive 10 weeks of CBT; Other: Treatment As Usual (TAU); Participants will receive standard of care treatment
Placebo Comparator: Saline Infusion; 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)	Other: Cognitive Behavior Therapy (CBT); Participants will receive 10 weeks of CBT; Other: Treatment As Usual (TAU); Participants will receive standard of care treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 Months and 6 Months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: Fox (Michael J.) Foundation for Parkinson's Research; Yale School of Medicine Center for Brain Mind Health
• Investigators: Principal Investigator: Sophie E. Holmes, PhD, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2023
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: December 1, 2023
• First Submitted That Met QC Criteria: December 1, 2023
• First Posted (Estimated): December 11, 2023

Study Record Updates

• Last Update Posted (Estimated): December 11, 2023
• Last Update Submitted That Met QC Criteria: December 1, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Long Term Effect Ketamine Treatment
• Additional Relevant MeSH Terms: Behavioral Symptoms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Depression; Parkinson Disease
• Other Study ID Numbers: 2000036071

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes