Trials / Terminated
TerminatedNCT03352453
A Study of Rapastinel for Rapid Treatment of Depression and Suicidality in Major Depressive Disorder
A Randomized, Double-blind, Placebo-controlled, Multicenter, Efficacy and Safety Study of Rapastinel for Rapid Treatment of Symptoms of Depression and Suicidality in Adult Patients With Major Depressive Disorder
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 138 (actual)
- Sponsor
- Naurex, Inc, an affiliate of Allergan plc · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
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
- 2017-12-15
- Primary completion
- 2019-06-21
- Completion
- 2019-06-21
- First posted
- 2017-11-24
- Last updated
- 2020-08-14
- Results posted
- 2020-08-14
Locations
17 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03352453. Inclusion in this directory is not an endorsement.