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

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