CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 465 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/NCT02932943
NCT02932943Phase 3Completed
CompareCT.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 13, 2016·Updated Oct 11, 2019

In Brief

A Phase 3 clinical trial evaluating Rapastinel and Placebo for Depressive Disorder, Major. Completed, enrolled 465 participants across 31 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepressive Disorder, Major
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedOct 13, 2016
Enrollment StartOct 15, 2016
Primary CompletionSep 21, 2018
Study CompletionNov 8, 2018
TodayJul 2, 2026
Enrollment to primary: 1.9 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.