A Randomized, Double-blind, Placebo-controlled, Multi-center Study of Rapastinel in the Prevention of Relapse in Patients With Major Depressive Disorder
Overview
- Phase
- Phase 3
- Intervention
- Rapastinel
- Conditions
- Depressive Disorder, Major
- Sponsor
- Naurex, Inc, an affiliate of Allergan plc
- Enrollment
- 363
- Locations
- 52
- Primary Endpoint
- Time to First Relapse During the 52 Weeks of the Double-Blind Treatment Period (DBTP)
- Status
- Terminated
- Last Updated
- 5 years ago
Overview
Brief Summary
The study will evaluate the efficacy, safety, and tolerability of 450 milligrams (mg) or 225 mg of Rapastinel compared to placebo in the prevention of relapse in participants with major depressive disorder (MDD).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Completion of Study RAP-MD-30, RAP-MD-31, or RAP-MD-32
- •If female of childbearing potential, have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test
Exclusion Criteria
- •DSM-5-based diagnosis of any disorder other than MDD that was the primary focus of treatment within 6 months before Visit 1
- •Lifetime history of meeting DSM-5 criteria for:
- •1.Schizophrenia spectrum or other psychotic disorder
- •2.Bipolar or related disorder
- •3.Major neurocognitive disorder
- •4.Neurodevelopmental disorder of greater than mild severity or of a severity that impacts the participant's ability to consent, follow study directions, or otherwise safely participate in the study
- •5.Dissociative disorder
- •6.Posttraumatic stress disorder
- •7.MDD with psychotic features
- •Significant suicide risk, as judged by the Investigator
Arms & Interventions
Rapastinel weekly
Rapastinel 450 mg or 225 mg (prefilled syringe, weekly intravenous IV administration)
Intervention: Rapastinel
Rapastinel clinically driven schedule
Rapastinel 450 mg or 225 mg (prefilled syringe, clinically driven schedule IV administration, variable interval, placebo on intervening weeks)
Intervention: Rapastinel
Placebo weekly
Placebo (prefilled syringe, weekly IV administration)
Intervention: Placebo
Outcomes
Primary Outcomes
Time to First Relapse During the 52 Weeks of the Double-Blind Treatment Period (DBTP)
Time Frame: 52 Weeks
The time in days to first relapse is defined as the number of days from the date of randomization to the first relapse.