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Ketamine for the Treatment of Depression in Parkinson's Disease

NCT04944017 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2025-12-08

No results posted yet for this study

Summary

The main purpose of this study is to examine the efficacy and safety of a repeated dosing ketamine infusion paradigm compared to placebo in individuals with PD.

A subset of participants in each arm will undergo baseline and post-treatment PET and fMRI scans, to examine whether changes in synaptic density and reorganization of functional networks underlie ketamine's putative antidepressant effects in PD.

Conditions

Interventions

DRUG

Ketamine Infusion

Participants will receive 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

OTHER

Placebo - Saline Infusion

Participants will receive 6 infusions of saline administered over 40 minutes while on continuous cardiac monitoring and oximetry

Sponsors & Collaborators

  • Fox (Michael J.) Foundation for Parkinson's Research

    collaborator UNKNOWN

  • Yale University

    lead OTHER

Principal Investigators

  • Sophie E. Holmes, PhD · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-23
Primary Completion
2025-09-24
Completion
2025-09-24
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04944017 on ClinicalTrials.gov