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

NCT ID: NCT05655507

Last Updated: 2025-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-19
• Study Completion Date: 2024-10-18

Brief Summary

The primary purpose of this study is to evaluate the pharmacokinetics and safety of Zuranolone in adolescents (ages 12 to 17 years) with MDD.

Detailed Description

This study was previously posted by Sage Therapeutics. In December 2024, sponsorship of the trial was transferred to Biogen.

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Zuranolone

Participants will be enrolled to receive Zuranolone orally, during the daytime on Day 1 and in the evening on Days 2 to 14. The first 10 enrolled participants will receive 50 mg (participants with a body weight of 54 kg or greater) or 40 mg (participants with a body weight less than 54 kg) once daily. The remaining participants will receive 40 mg once daily with the opportunity to down titrate to 30 mg if 40 mg is not tolerated.

Group Type: EXPERIMENTAL

Zuranolone

Intervention Type: DRUG

Administered as capsules

Interventions

Zuranolone

Administered as capsules

Intervention Type: DRUG

Other Intervention Names

SAGE-217, BIIB125

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

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Biogen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Biogen

Locations

Sage Investigational Site

Atlanta, Georgia, United States

Sage Investigational Site

Decatur, Georgia, United States

Sage Investigational Site

Flowood, Mississippi, United States

Sage Investigational Site

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

NCT05655507

Identifier Type: OTHER

Identifier Source: secondary_id

217-CLP-118

Identifier Type: -

Identifier Source: org_study_id