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NCT02943564 · ClinicalTrials.gov registry record · Phase 3
A Study of Rapastinel as Adjunctive Therapy in Major Depressive Disorder (RAP-MD-02)
A Phase 3 study, sponsored by Naurex, Inc, an affiliate of Allergan.
- Completed
- Registry status
- Phase 3
- Development phase
- 658
- Enrollment target
NCT02943564: Completed Phase 3 study, sponsored by Naurex, Inc, an affiliate of Allergan.
NCT02943564 is a Phase 3 study that has completed, run by Naurex, Inc, an affiliate of Allergan. The registered enrollment target is 658 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (15% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02943564, a Phase 3 study, has completed, sponsored by Naurex, Inc, an affiliate of Allergan.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 658 participants
- Enrollment target
Study Summary
This study will evaluate the efficacy, safety, and tolerability of two doses of rapastinel, 225 milligrams (mg) and 450 mg, compared to placebo adjunctive to antidepressant therapy (ADT) in patients with major depressive disorder (MDD) who have a partial response to ADT.
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 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 | 658 participants |
| Start Date | 2016-11-01 |
| Est. Completion | 2018-12-18 |
| Phase | Phase 3 |
What the finished NCT02943564 record still lists
NCT02943564 is an interventional study that assigns participants to a tested intervention. The registered 658 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (15% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02943564 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02943564 about?
NCT02943564 is a clinical study titled "A Study of Rapastinel as Adjunctive Therapy in Major Depressive Disorder (RAP-MD-02)". This study will evaluate the efficacy, safety, and tolerability of two doses of rapastinel, 225 milligrams (mg) and 450 mg, compared to placebo adjunctive to antidepressant therapy (ADT) in patients with major depressive disorder (MDD) who have a partial response to ADT.
What is the current status of trial NCT02943564?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 658 participants. The study started on 2016-11-01. Estimated completion is 2018-12-18.
What interventions are being tested in trial NCT02943564?
The interventions under investigation include: Placebo (DRUG), Rapastinel (DRUG).
Who is sponsoring clinical trial NCT02943564?
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 NCT02943564's enrollment target sits among peer trials
658 563rd of 2000 higher than 1,437 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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