SAGE-217 Pharmacokinetics (PK) and Safety Study Pediatric Participants With Major Depressive Disorder (MDD)

• Status: Not yet recruiting
• Trial end date: 2024-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary purpose of this study is to evaluate the pharmacokinetics and safety of SAGE-217 in adolescents (ages 12 to 17 years) and children (ages 7 to 11 years) with MDD.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sage Therapeutics

Criteria

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 score greater than or equal to 40 at screening and Day 1.

• Participant's parent/caregiver is able to attend all scheduled study visits, oversee administration 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 index greater than fifth percentile and less than ninety-fifth percentile for age at Screening.

Exclusion Criteria:

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

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

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

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

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