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NCT03002077 · ClinicalTrials.gov registry record · Phase 3
Long-term Safety Study of Rapastinel as Adjunctive Therapy in Patients With Major Depressive Disorder
A Phase 3 study, sponsored by Naurex, Inc, an affiliate of Allergan.
- Completed
- Registry status
- Phase 3
- Development phase
- 617
- Enrollment target
NCT03002077: Completed Phase 3 study, sponsored by Naurex, Inc, an affiliate of Allergan.
NCT03002077 is a Phase 3 study that has completed, run by Naurex, Inc, an affiliate of Allergan. The registered enrollment target is 617 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03002077, a Phase 3 study, has completed, sponsored by Naurex, Inc, an affiliate of Allergan.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 617 participants
- Enrollment target
Study Summary
This study will evaluate the long-term safety and tolerability of rapastinel as an adjunctive to antidepressant therapy (ADT) in patients with major depressive disorder (MDD).
Primary Outcome
An AE is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Interventions
- DRUG Rapastinel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 617 participants |
| Start Date | 2017-02-03 |
| Est. Completion | 2018-12-06 |
| Phase | Phase 3 |
What the finished NCT03002077 record still lists
NCT03002077 is an interventional study that assigns participants to a tested intervention. The registered 617 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 (20% lower).
The record links to 0 conditions, and to 1 intervention - of which Rapastinel is the first listed.
NCT03002077 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03002077 about?
NCT03002077 is a clinical study titled "Long-term Safety Study of Rapastinel as Adjunctive Therapy in Patients With Major Depressive Disorder". This study will evaluate the long-term safety and tolerability of rapastinel as an adjunctive to antidepressant therapy (ADT) in patients with major depressive disorder (MDD).
What is the current status of trial NCT03002077?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 617 participants. The study started on 2017-02-03. Estimated completion is 2018-12-06.
What interventions are being tested in trial NCT03002077?
The interventions under investigation include: Rapastinel (DRUG).
Who is sponsoring clinical trial NCT03002077?
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 NCT03002077's enrollment target sits among peer trials
617 592nd of 2000 higher than 1,408 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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