At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 617 enrolled
Drug / intervention
Rapastineldrug
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.
An Open-label, Long-term Safety Study of Rapastinel as Adjunctive Therapy in Patients With Major Depressive Disorder
In Brief
A Phase 3 clinical trial evaluating Rapastinel for Depressive Disorder, Major. Completed, enrolled 617 participants across 128 sites.
Detailed Summary
This study will evaluate the long-term safety and tolerability of rapastinel as an adjunctive to antidepressant therapy (ADT) in patients with major depressive disorder (MDD).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepressive Disorder, Major
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedDec 2016
Enrollment StartFeb 2017
Primary CompletionDec 2018
TodayJul 2026
First PostedDec 23, 2016
Enrollment StartFeb 3, 2017
Primary CompletionDec 6, 2018
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 9.5 years ago
Interventions
Rapastineldrug
Rapastinel pre-filled syringes for IV injections.