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Completed Phase 1 Interventional

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

ClinicalTrials.gov ID: NCT05655507

Public ClinicalTrials.gov record NCT05655507. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 22, 2026, 4:22 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official 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

Study identification

NCT ID
NCT05655507
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Biogen
Industry
Enrollment
19 participants

Conditions and interventions

Interventions

  • Zuranolone Drug

Drug

Eligibility (public fields only)

Age range
12 Years to 17 Years
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 18, 2023
Primary completion
Oct 17, 2024
Completion
Oct 17, 2024
Last update posted
Mar 25, 2025

2023 – 2024

United States locations

U.S. sites
4
U.S. states
3
U.S. cities
4
Facility City State ZIP Site status
Sage Investigational Site Atlanta Georgia 30331
Sage Investigational Site Decatur Georgia 30030
Sage Investigational Site Flowood Mississippi 39232
Sage Investigational Site Cincinnati Ohio 45219

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05655507, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 25, 2025 · Synced Jul 22, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05655507 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →