Phase 3 Completed N=1,304 Randomized Triple-blind Treatment

A Study of Rapastinel as Adjunctive Therapy in the Prevention of Relapse in Patients With Major Depressive Disorder

Depressive Disorder, Major

Source: ClinicalTrials.gov NCT02951988 ↗

Enrolled (actual)

1,304

Serious AEs

2.1%

Results posted

Mar 2020

Primary outcomePrimary: Time to First Relapse During the First 52 Weeks of the Double-Blind Treatment Period — 232; 225; 336 Days — p=0.5305

◆ Published Evidence

No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

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).

Outcome Measures

Outcome	Result	p-value
PRIMARY Time to First Relapse During the First 52 Weeks of the Double-Blind Treatment Period	232; 225; 336	0.5305
PRIMARY Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS) Using 5-Point Scales	17; 25; 23; 0; 0; 1	—
SECONDARY Time to First Relapse During the Entire Double-Blind Treatment Period	232; 225; 336	0.6153

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02951988). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.