At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,304 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.
A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Rapastinel as Adjunctive Therapy in the Prevention of Relapse in Patients With Major Depressive Disorder
In Brief
A Phase 3 clinical trial evaluating Rapastinel and Placebo-matching Rapastinel for Depressive Disorder, Major. Completed, enrolled 1,304 participants across 137 sites.
Detailed Summary
This study will evaluate the efficacy, safety and tolerability of rapastinel 450 milligrams (mg) intravenous (IV) once weekly or once every 2 weeks versus placebo as an adjunctive treatment to ongoing anti-depressive therapy (ADT) in the prevention of relapse in participants with Major Depressive Disorder (MDD).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepressive Disorder, Major
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedNov 2016
Enrollment StartNov 2016
Primary CompletionFeb 2019
TodayJul 2026
First PostedNov 1, 2016
Enrollment StartNov 13, 2016
Primary CompletionFeb 22, 2019
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 9.7 years ago
Interventions
Rapastineldrug
Rapastinel pre-filled syringes for IV injections.
Placebo-matching Rapastineldrug
Placebo-matching rapastinel pre-filled syringes for weekly IV injections.