A Study of Rapastinel for Rapid Treatment of Depression and Suicidality in Major Depressive Disorder

A Randomized, Double-blind, Placebo-controlled, Multicenter, Efficacy and Safety Study of Rapastinel for Rapid Treatment of Symptoms of Depression and Suicidality in Adult Patients With Major Depressive Disorder

The study will evaluate the efficacy, safety, and tolerability of 450 milligrams (mg) of Rapastinel, compared to placebo in adult patients with major depressive disorder (MDD) who are at imminent risk of suicide.

Inclusion Criteria:

• Meet Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5) criteria for MDD
• Current major Depressive episode of at least 4 weeks and not exceeding 24 months in duration at visit 1
• Have current, ongoing suicidality (ideation or behavior) of sufficient severity to warrant hospitalization based on the judgment of the investigator
• 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 1 month before Visit 1.

• Lifetime history or currently meet 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 homicidal ideation or at imminent risk of injuring others or causing significant damage to property, as judged by the investigator.

• Prior participation in any investigational study of rapastinel/GLYX-13