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NCT04944017 · ClinicalTrials.gov registry record · Phase 2
Ketamine for the Treatment of Depression in Parkinson's Disease
A Phase 2 study of Depression and Parkinson's Disease, sponsored by Yale University.
- Completed
- Registry status
- Phase 2
- Development phase
- 51
- Enrollment target
- 1
- Study location
NCT04944017: Completed Phase 2 study of Depression and Parkinson's Disease, sponsored by Yale University.
NCT04944017 is a Phase 2 study of Depression and Parkinson's Disease that has completed, run by Yale University. The registered enrollment target is 51 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04944017, a Phase 2 study of Depression and Parkinson's Disease, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 51 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
The primary outcome of depression severity post-treatment will be compared between groups using a linear mixed model with group (ketamine, placebo) included as a between-subjects factor and time (baseline, weeks 1, 2, 3) included as a within-subjects factor. 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 patient
Conditions Studied
Interventions
- DRUG Ketamine Infusion
- OTHER Placebo - Saline Infusion
Study Locations (1)
Connecticut
- Yale New Haven Hospital - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2021-11-23 |
| Est. Completion | 2025-09-24 |
| Phase | Phase 2 |
What the finished NCT04944017 record still lists
NCT04944017 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 786-participant average among 679 other Depression trials with a reported enrollment target (94% lower).
The record links to 2 conditions, with Depression appearing as the primary indexed condition, and to 2 interventions - of which Ketamine Infusion is the first listed.
NCT04944017 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT04944017 about?
NCT04944017 is a clinical study titled "Ketamine for the Treatment of Depression in Parkinson's Disease". 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 d...
What is the current status of trial NCT04944017?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 51 participants. The study started on 2021-11-23. Estimated completion is 2025-09-24.
What conditions does trial NCT04944017 study?
This clinical trial studies the following conditions: Depression, Parkinson's Disease.
What interventions are being tested in trial NCT04944017?
The interventions under investigation include: Ketamine Infusion (DRUG), Placebo - Saline Infusion (OTHER).
Who is sponsoring clinical trial NCT04944017?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04944017 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Depression
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04944017's enrollment target sits among peer trials
51 466th of 679 higher than 213 of 679 other Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Depression trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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