A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Rapastinel as Adjunctive Therapy 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
- 1304
- Locations
- 131
- Primary Endpoint
- Time to First Relapse During the First 52 Weeks of the Double-Blind Treatment Period
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief 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).
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 Screening
- •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 Screening
- •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 450 mg Every 2 Weeks
Rapastinel 450 mg IV once a week during OLTP followed by rapastinel 450 mg IV once every 2 weeks during DBTP.
Intervention: Rapastinel
Rapastinel 450 mg Weekly
Rapastinel 450 milligrams (mg) intravenous (IV) once a week during OLTP followed by rapastinel 450 mg IV once a week during DBTP.
Intervention: Rapastinel
Placebo
Rapastinel 450 mg IV once a week during OLTP followed by placebo-matching rapastinel 450 mg IV once a week during DBTP.
Intervention: Placebo-matching Rapastinel
Outcomes
Primary Outcomes
Time to First Relapse During the First 52 Weeks of the Double-Blind Treatment Period
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.
Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS) Using 5-Point Scales
Time Frame: 104 Weeks
On the C-SSRS, the 5 types of suicidal ideation are: Type 1: "Wish to be dead" Type 2: Non-specific active suicidal thoughts Type 3: "Active suicidal ideation with any methods (not plan) without intent to act" Type 4: "Active suicidal ideation with some intent to act, without specific plan" Type 5: "Active suicidal ideation with specific plan and intent"
Secondary Outcomes
- Time to First Relapse During the Entire Double-Blind Treatment Period(104 Weeks)