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

Sponsor

Sage Therapeutics (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05655507

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder	Drug: SAGE-217	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

36 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase 1, 2-Part Study to Evaluate the Pharmacokinetics and Safety of SAGE-217 in Adolescents (Part A: 12 to 17 Years of Age) and Children (Part B: 7 to 11 Years of Age) With Major Depressive Disorder

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Apr 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Part A: SAGE-217 Adolescents (12-17 years of age) will be enrolled to receive SAGE-217 orally in the morning on Day 1 and in the evening on Days 2 to 14. Participants with a body weight of greater than or equal to 54 kilograms (kg) will receive 50 mg, and participants with a body weight less than 54 kg will receive 40 mg.	Drug: SAGE-217 Administered as capsules Other Names: Zuranolone
Experimental: Part B: SAGE-217 Children (7-11 years of age) will be enrolled to receive SAGE-217 orally in the morning on Day 1 and in the evening on Days 2 to 14. The dose to be administered will be determined after review of safety and PK data in Part A.	Drug: SAGE-217 Administered as capsules Other Names: Zuranolone

Arm

Intervention/Treatment

Experimental: Part A: SAGE-217

Adolescents (12-17 years of age) will be enrolled to receive SAGE-217 orally in the morning on Day 1 and in the evening on Days 2 to 14. Participants with a body weight of greater than or equal to 54 kilograms (kg) will receive 50 mg, and participants with a body weight less than 54 kg will receive 40 mg.

Drug: SAGE-217

Administered as capsules

Other Names:

Zuranolone

Experimental: Part B: SAGE-217

Children (7-11 years of age) will be enrolled to receive SAGE-217 orally in the morning on Day 1 and in the evening on Days 2 to 14. The dose to be administered will be determined after review of safety and PK data in Part A.

Drug: SAGE-217

Administered as capsules

Other Names:

Zuranolone

Outcome Measures

Primary Outcome Measures

Plasma Concentrations of SAGE-217 [At multiple timepoints post dose on Days 1, 8 and 15]
PK Parameters of SAGE-217 will be assessed.

Secondary Outcome Measures

Percentage of Participants With at Least one Treatment Emergent Adverse Event (TEAE) [Up to 42 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.