CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 658 enrolled
Drug / intervention
Rapastinel +1 moredrug
Likely dose
Rapastinel pre-filled syringes for weekly IV injectionsAI-extracted
Key inclusion· 3
  • ✓Meet DSM-5 criteria for major depressive disorder (MDD)
  • ✓Current major depressive episode lasting 8 weeks to 18 months
  • ✓Partial response only (<50% improvement) to ongoing protocol-allowed antidepressant
Key exclusion· 8
  • ✕Lifetime history of schizophrenia spectrum or other psychotic disorder
  • ✕Lifetime history of bipolar or related disorder
  • ✕Lifetime history of major neurocognitive disorder
  • ✕Lifetime history of neurodevelopmental disorder of greater than mild severity that impacts ability to consent or participate

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

Search/NCT02943564
NCT02943564Phase 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 24, 2016·Updated Dec 27, 2019

In Brief

A Phase 3 clinical trial evaluating Rapastinel and Placebo for Depressive Disorder, Major. Completed, enrolled 658 participants across 66 sites.

Detailed 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.

Study Details

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

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedOct 24, 2016
Enrollment StartNov 1, 2016
Primary CompletionDec 12, 2018
Study CompletionDec 18, 2018
TodayJul 2, 2026
Enrollment to primary: 2.1 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.