A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Rapastinel as Monotherapy in Patients With Major Depressive Disorder
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Sponsor
- Enrollment
- 50
- Locations
- 23
- Primary Endpoint
- Change From Baseline on Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at End of Double-blind Treatment (End of Week 6).
Study Overview
Brief Summary
The study will evaluate the efficacy, safety, and tolerability of 225 milligrams (mg) and 450 milligrams (mg) of Rapastinel, compared to placebo in participants with major depressive disorder (MDD).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for MDD
- •Current major depressive episode of at least 8 weeks and not exceeding 18 months in duration at Visit 1
- •Treatment naive in the current episode or have inadequate response to 1-3 antidepressant therapies given at adequate dose and duration in the current episode
- •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:
- •Schizophrenia spectrum or other psychotic disorder
- •Bipolar or related disorder
- •Major neurocognitive disorder
- •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
- •Dissociative disorder
- •Posttraumatic stress disorder
- •MDD with psychotic features
- •Significant suicide risk, as judged by the investigator
Arms & Interventions
Rapastinel 450mg
Rapastinel (prefilled syringe, weekly intravenous IV administration).
Intervention: Rapastinel (Drug)
Rapastinel 225mg
Rapastinel (prefilled syringe, weekly intravenous IV administration).
Intervention: Rapastinel (Drug)
Placebo
Placebo (prefilled syringe, weekly IV administration).
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Change From Baseline on Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at End of Double-blind Treatment (End of Week 6).
Time Frame: Baseline to end of Week 6
The MADRS is a clinician-rated scale to assess depressive symptomatology during the preceding week. Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and a lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change score indicates improvement.
Secondary Outcomes
- Change From Baseline in MADRS Total Score at 1 Day After First Dose of Treatment(Baseline to 1 Day post-first dose)