Study of Adjunctive or Monotherapy Rapastinel Treatment in Patients With Major Depressive Disorder (MDD)

Inclusion Criteria:

- Completion of lead-in study

- Adequate therapeutic benefit in the lead-in study to justify continuation of treatment
with rapastinel in the judgement of the investigator

Exclusion Criteria:

- Suicide risk, as determined by meeting any of the following criteria:

1. A suicide attempt within the past year

2. Significant risk, as judged by the investigator, based on the psychiatric
interview or information collected in the Columbia- Suicide Severity Rating Scale
(C-SSRS) at any visit in the lead-in study

3. Montgomery-Asberg Depression Rating Scale (MADRS) Item 10 score ≥ 5 at any visit
during participation in the lead-in study where MADRS was conducted.

- At imminent risk of injuring self or others or causing significant damage to property,
as judged by the investigator

- Females who are pregnant, breastfeeding, or planning to become pregnant or breastfeed
during participation

- Females of childbearing potential and male partners of females of childbearing
potential, not using a reliable means of contraception