Trials / Completed
CompletedNCT02943564
A Study of Rapastinel as Adjunctive Therapy in Major Depressive Disorder (RAP-MD-02)
A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Rapastinel as Adjunctive Therapy in Major Depressive Disorder
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 658 (actual)
- Sponsor
- Naurex, Inc, an affiliate of Allergan plc · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Rapastinel | Rapastinel pre-filled syringes for weekly IV injections. |
| DRUG | Placebo | Placebo-matching rapastinel pre-filled syringes for weekly IV injections. |
Timeline
- Start date
- 2016-11-01
- Primary completion
- 2018-12-12
- Completion
- 2018-12-18
- First posted
- 2016-10-24
- Last updated
- 2019-12-27
- Results posted
- 2019-12-27
Locations
66 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02943564. Inclusion in this directory is not an endorsement.