A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Rapastinel as Adjunctive Therapy in Major Depressive Disorder
Overview
- Phase
- Phase 3
- Intervention
- Rapastinel
- Conditions
- Depressive Disorder, Major
- Sponsor
- Naurex, Inc, an affiliate of Allergan plc
- Enrollment
- 465
- Locations
- 28
- Primary Endpoint
- Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at the End of Trial
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
This study will evaluate the efficacy, safety, and tolerability of rapastinel 450 mg compared to placebo adjunctive to antidepressant therapy (ADT) in patients with major depressive disorder (MDD) who have a partial response to ADT.
Investigators
Eligibility Criteria
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
- •Have no more than partial response (\< 50% improvement) to ongoing treatment with a protocol-allowed antidepressant
- •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 stess disorder
- •MDD with psychotic features
- •Significant suicide risk, as judged by the Investigator.
Arms & Interventions
Rapastinel 450 mg
Rapastinel 450 milligram (mg) weekly intravenous (IV) injections. Each participant will continue to take the same dose of antidepressant therapy the participant was receiving prior to entering this study throughout treatment.
Intervention: Rapastinel
Placebo
Placebo-matching rapastinel weekly IV injections. Each participant will continue to take the same dose of antidepressant therapy the participant was receiving prior to entering this study throughout treatment.
Intervention: Placebo
Outcomes
Primary Outcomes
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at the End of Trial
Time Frame: Baseline and 3 Weeks
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 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(Baseline and Day 8)
- Change From Baseline to Day 8 in MADRS Total Score for the Placebo Non-responders of mITT Population(Baseline and Day 8)
- Change From Baseline to Day 21 in MADRS Total Score for the Placebo Non-responders of mITT Population(Baseline and Day 21)