Zuranolone Pharmacokinetics (PK) and Safety Study Adolescent Participants With Major Depressive Disorder (MDD)

Inclusion Criteria:

• Participant meets Kiddie Schedule for Affective Disorders and Schizophrenia -Present and Lifetime DSM-5 (KSADS-PL DSM-5) criteria for MDD.

• Participant has a Children's Depression Rating Scale-Revised (CDRS-R) total scoregreater than or equal to 40 at screening and Day 1.

• Participant's parent/caregiver is able to attend all scheduled study visits, overseeadministration of study drug and complete assessments per the protocol.

• Participant has a body weight greater than or equal to 20 kg and a body mass indexgreater than fifth percentile and less than ninety-fifth percentile for age atScreening.

• Participant is a post-pubertal (has experienced menarche) female (sex assigned atbirth), 12 to 17 years of age, inclusive, at the time informed consent/assent isobtained.

Exclusion Criteria:

• Participant has a history of psychosis, bipolar disorder, autism, seizures, or otherrestricted comorbid psychiatric or neurological conditions and hastreatment-resistant depression.

• Participant has a known diagnosis of intellectual disability or is unable tocommunicate with the study investigator or research team.

• Participant has a history of suicidal behavior or is currently at risk of suicide inthe opinion of the investigator.

• Participant has a recent history of Diagnostic and Statistical Manual of MentalDisorders, 5th Edition (DSM 5) alcohol or drug use disorder or has clinicallysignificant alcohol or drug misuse as judged by the investigator.

Note: Other protocol-defined inclusion/exclusion criteria may apply.