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NCT02932943 · ClinicalTrials.gov registry record · Phase 3
A Study of Rapastinel as Adjunctive Therapy in Major Depressive Disorder (RAP-MD-01)
A Phase 3 study of Depressive Disorder, Major, sponsored by Naurex, Inc, an affiliate of Allergan.
- Completed
- Registry status
- Phase 3
- Development phase
- 465
- Enrollment target
- 20
- Study locations
NCT02932943: Completed Phase 3 study of Depressive Disorder, Major, sponsored by Naurex, Inc, an affiliate of Allergan.
NCT02932943 is a Phase 3 study of Depressive Disorder, Major that has completed, run by Naurex, Inc, an affiliate of Allergan. The registered enrollment target is 465 participants, above the 233-participant average among 52 other Depressive Disorder, Major trials with a reported enrollment target (100% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02932943, a Phase 3 study of Depressive Disorder, Major, has completed, sponsored by Naurex, Inc, an affiliate of Allergan.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 465 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will evaluate the efficacy, safety, and tolerability of rapastinel 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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Rapastinel
Study Locations (20)
California
- Southern California Research LLC. - Beverly Hills
- ATP Clinical Research Inc. - Costa Mesa
- Pharmacology Research Institute - Encino
- Collaborative Neuroscience Network, LLC - Garden Grove
- Synergy San Diego - Lemon Grove
- Pharmacology Research Institute - Los Alamitos
- Excell Research - Oceanside
- Anderson Clinical Research - Redlands
- Thomas M. Shiovitz, M.D., Inc., DBA California Neuroscience Research Medical Group, Inc., - Sherman Oaks
- Viking Clinical Research - Temecula
- Pacific Clinical Research Medical - Upland
Florida
- Meridien Research - Bradenton
- MD Clinical - Hallandale
- Clinical Neuroscience Solutions, Inc - Jacksonville
- Meridien Research - Lakeland
Georgia
- Institute for Advanced Medical Research - Alpharetta
- Atlanta Center for Medical Research - Atlanta
Connecticut
- Comprehensive Psychiatric Care - Norwich
Massachusetts
- Adams Clinical Trials - Watertown
Nevada
- Altea Research - Las Vegas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 465 participants |
| Start Date | 2016-10-15 |
| Est. Completion | 2018-11-08 |
| Phase | Phase 3 |
What the finished NCT02932943 record still lists
NCT02932943 is an interventional study that assigns participants to a tested intervention. The registered 465 participants enrollment target is mid-sized for trials with a published cap, above the 233-participant average among 52 other Depressive Disorder, Major trials with a reported enrollment target (100% higher).
The record links to 1 condition, with Depressive Disorder, Major appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02932943 names 20 study sites across 6 states, led by California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT02932943 about?
NCT02932943 is a clinical study titled "A Study of Rapastinel as Adjunctive Therapy in Major Depressive Disorder (RAP-MD-01)". This study will evaluate the efficacy, safety, and tolerability of rapastinel 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 NCT02932943?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 465 participants. The study started on 2016-10-15. Estimated completion is 2018-11-08.
What conditions does trial NCT02932943 study?
This clinical trial studies the following conditions: Depressive Disorder, Major.
What interventions are being tested in trial NCT02932943?
The interventions under investigation include: Placebo (DRUG), Rapastinel (DRUG).
Who is sponsoring clinical trial NCT02932943?
This trial is sponsored by Naurex, Inc, an affiliate of Allergan, which has 18 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02932943 being conducted?
This trial has 20 study locations across California, Connecticut, Florida, Georgia, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Depressive Disorder, Major
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 NCT02932943's enrollment target sits among peer trials
465 12th of 52 higher than 41 of 52 other Depressive Disorder, Major trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Depressive Disorder, Major 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.
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