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NCT03149991 · ClinicalTrials.gov registry record · Phase 4
A Study of Brexpiprazole Plus Ketamine in Treatment-Resistant Depression (TRD)
A Phase 4 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 51
- Enrollment target
NCT03149991: Completed Phase 4 study, sponsored by Massachusetts General Hospital.
NCT03149991 is a Phase 4 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 51 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03149991, a Phase 4 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 51 participants
- Enrollment target
Study Summary
This is a multi-site, double-blind, placebo-controlled study of the acute efficacy of brexpiprazole or placebo in combination with intranasal ketamine added to ongoing, stable, and adequate antidepressant therapy (ADT) in the treatment of adults with Major Depressive Disorder with Treatment Resistant Depression.
Primary Outcome
Superiority will be demonstrated by a statistically significant greater decrease (p\<0.05, 2 sided) on the SDQ total score for participants receiving brexpiprazole versus placebo therapy. Symptoms of Depression Questionnaire (SDQ): This validated self-rating instrument has 44 items on a scale of 1-6, measuring multiple depressive symptom domains, with higher scores indicating worse depression symptoms. Participants reported on their experiences over the past three days.
Interventions
- DRUG Placebo
- DRUG Ketamine
- DRUG Brexpiprazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2017-09-14 |
| Est. Completion | 2019-06-15 |
| Phase | Phase 4 |
What the finished NCT03149991 record still lists
NCT03149991 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 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03149991 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03149991 about?
NCT03149991 is a clinical study titled "A Study of Brexpiprazole Plus Ketamine in Treatment-Resistant Depression (TRD)". This is a multi-site, double-blind, placebo-controlled study of the acute efficacy of brexpiprazole or placebo in combination with intranasal ketamine added to ongoing, stable, and adequate antidepressant therapy (ADT) in the treatment of adults with Major Depressive Disorder with Treatment Resistan...
What is the current status of trial NCT03149991?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 51 participants. The study started on 2017-09-14. Estimated completion is 2019-06-15.
What interventions are being tested in trial NCT03149991?
The interventions under investigation include: Placebo (DRUG), Ketamine (DRUG), Brexpiprazole (DRUG).
Who is sponsoring clinical trial NCT03149991?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03149991's enrollment target sits among peer trials
51 1249th of 2000 higher than 746 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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