Long Term Follow Up KET-PD

NCT06164756 | Enrolling By Invitation

• 1 other identifier: 2000036071
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease; Depression

Keywords

Long Term Effect Ketamine Treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change in Apathy

  3 Months and 6 Months

• Change in Anxiety

  3 Months and 6 Months

• Change in Parkinson's Symptom Severity

  3 Months and 6 Months

• Change in Dyskinesia

  3 Months and 6 Months

• Change in Pain

  3 Months and 6 Months

Study Arms (2)

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); Other: Treatment As Usual (TAU)

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); Other: Treatment As Usual (TAU)

Interventions

Cognitive Behavior Therapy (CBT) OTHER

Participants will receive 10 weeks of CBT

Experimental: Ketamine Infusion; Placebo Comparator: Saline Infusion

Treatment As Usual (TAU) OTHER

Participants will receive standard of care treatment

Experimental: Ketamine Infusion; Placebo Comparator: Saline Infusion

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Yale University: lead
• Fox (Michael J.) Foundation for Parkinson's Research: collaborator
• Yale School of Medicine Center for Brain Mind Health: collaborator

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Depression

Interventions

Cognitive Behavioral Therapy; Therapeutics

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Sophie E. Holmes, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry

Study Record Dates

• First Submitted: December 1, 2023
• First Posted: December 11, 2023
• Study Start: October 18, 2023
• Primary Completion: December 21, 2025
• Study Completion: December 21, 2025
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)