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NCT03352453 · ClinicalTrials.gov registry record · Phase 2
A Study of Rapastinel for Rapid Treatment of Depression and Suicidality in Major Depressive Disorder
A Phase 2 study, sponsored by Naurex, Inc, an affiliate of Allergan.
- Terminated
- Registry status
- Phase 2
- Development phase
- 138
- Enrollment target
NCT03352453: Clinical Trial Phase 2 study, sponsored by Naurex, Inc, an affiliate of Allergan.
NCT03352453 is a Phase 2 study that was terminated before completion, run by Naurex, Inc, an affiliate of Allergan. The registered enrollment target is 138 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03352453, a Phase 2 study, was terminated before completion, sponsored by Naurex, Inc, an affiliate of Allergan.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 138 participants
- Enrollment target
Study Summary
The study will evaluate the efficacy, safety, and tolerability of 450 milligrams (mg) of Rapastinel, compared to placebo in adult patients with major depressive disorder (MDD) who are at imminent risk of suicide.
Primary Outcome
The MADRS is a clinician-rated scale to assess depressive symptomatology during the preceding week. Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and a lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change score indicates improvement.
Interventions
- DRUG Placebo
- DRUG Rapastinel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 138 participants |
| Start Date | 2017-12-15 |
| Est. Completion | 2019-06-21 |
| Phase | Phase 2 |
Why NCT03352453 stopped before completion
NCT03352453 is an interventional study that assigns participants to a tested intervention. The registered 138 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03352453 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03352453 about?
NCT03352453 is a clinical study titled "A Study of Rapastinel for Rapid Treatment of Depression and Suicidality in Major Depressive Disorder". The study will evaluate the efficacy, safety, and tolerability of 450 milligrams (mg) of Rapastinel, compared to placebo in adult patients with major depressive disorder (MDD) who are at imminent risk of suicide.
What is the current status of trial NCT03352453?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 138 participants. The study started on 2017-12-15. Estimated completion is 2019-06-21.
What interventions are being tested in trial NCT03352453?
The interventions under investigation include: Placebo (DRUG), Rapastinel (DRUG).
Who is sponsoring clinical trial NCT03352453?
This trial is sponsored by Naurex, Inc, an affiliate of Allergan, which has 18 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03352453's enrollment target sits among peer trials
138 525th of 2000 higher than 1,474 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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