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Trials / Completed

CompletedNCT05655507

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

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

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
19 (actual)
Sponsor
Biogen · Industry
Sex
Female
Age
12 Years – 17 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DRUGZuranoloneAdministered as capsules

Timeline

Start date
2023-04-19
Primary completion
2024-10-18
Completion
2024-10-18
First posted
2022-12-19
Last updated
2025-03-26

Locations

4 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT05655507. Inclusion in this directory is not an endorsement.

Zuranolone Pharmacokinetics (PK) and Safety Study Adolescent Participants With Major Depressive Disorder (MDD) (NCT05655507) · Clinical Trials Directory