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

NCT05655507 | Completed Phase 1 DMC FDA Drug

• 2 other identifiers: 217-CLP-118NCT05655507
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 4

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.

Conditions

Major Depressive Disorder

Keywords

Major Depressive Disorder; MDD; Depression; Pediatrics; Child; Adolescent; SAGE-217; Zuranolone

Outcome Measures

Primary Outcomes (1)

• Plasma Concentrations of Zuranolone

  PK Parameters of Zuranolone will be assessed.

  At multiple timepoints post dose on Days 1, 8 and 15

Secondary Outcomes (1)

• Percentage of Participants With at Least one Treatment Emergent Adverse Event (TEAE)

  Up to 42 days

Study Arms (1)

Zuranolone

EXPERIMENTAL

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.

Drug: Zuranolone

Interventions

Zuranolone DRUG

Administered as capsules

Also known as: SAGE-217, BIIB125

Zuranolone

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogen: lead

Study Sites (4)

Sage Investigational Site

Atlanta, Georgia, 30331, United States

Location

Sage Investigational Site

Decatur, Georgia, 30030, United States

Location

Sage Investigational Site

Flowood, Mississippi, 39232, United States

Location

Sage Investigational Site

Cincinnati, Ohio, 45219, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

zuranolone

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2022
• First Posted: December 19, 2022
• Study Start: April 19, 2023
• Primary Completion: October 18, 2024
• Study Completion: October 18, 2024
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

US (4)