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Completed

NCT Number: NCT05655507

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

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

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Key information

Conditions

Major Depressive Disorder Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

12 year–17 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Sage Investigational Site, Atlanta, Georgia, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

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

Treatment and study plan

Zuranolone

Drug

Administered as capsules

Other names: SAGE-217, BIIB125

Primary outcomes

  1. Plasma Concentrations of Zuranolone

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

    PK Parameters of Zuranolone will be assessed.

Secondary outcomes

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

    Time frame: Up to 42 days

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study title

A Phase 1, Study to Evaluate the Pharmacokinetics and Safety of Zuranolone in Adolescents (12 to 17 Years of Age) With Major Depressive Disorder

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 19, 2022
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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