At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 429 enrolled

Drug / intervention

Rapastinel +1 moredrug

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02943577

NCT02943577Phase 3Completed

Compare CT.gov

A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Rapastinel as Adjunctive Therapy in Major Depressive Disorder

Naurex, Inc, an affiliate of Allergan plc·interventional·Posted Oct 24, 2016·Updated Nov 13, 2019

In Brief

A Phase 3 clinical trial evaluating Rapastinel and Placebo for Depressive Disorder, Major. Completed, enrolled 429 participants across 40 sites.

Detailed Summary

This study will evaluate the efficacy, safety, and tolerability of rapastinel 450 milligrams (mg) compared to placebo adjunctive to antidepressant therapy (ADT) in patients with major depressive disorder (MDD) who have a partial response to ADT.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsDepressive Disorder, Major

CountriesUnited States

Collaborators--

Timeline

Phase 3CompletedFinished

2017201820192020202120222023202420252026

First PostedOct 2016

Enrollment StartNov 2016

Primary CompletionOct 2018

Study CompletionNov 2018

TodayJul 2026

First PostedOct 24, 2016

Enrollment StartNov 2, 2016

Primary CompletionOct 26, 2018

Study CompletionNov 21, 2018

TodayJul 2, 2026

Enrollment to primary: 2.0 yearsPosted 9.7 years ago

Interventions

Rapastineldrug

Rapastinel pre-filled syringes for weekly IV injections.

Placebodrug

Placebo-matching rapastinel pre-filled syringes for weekly IV injections.