Independent directory Public ClinicalTrials.gov records United States
ClinicalTrials.gov record
Completed Phase 1 Interventional

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

ClinicalTrials.gov ID: NCT05655507

Open the official record

This page only displays public information reproduced from the official ClinicalTrials.gov record NCT05655507. It adds no medical advice, opinions, or eligibility judgments. The official record remains the source of truth for eligibility criteria, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Nov 11, 2026, 10:01 PM EST

All trial information on this site comes from the official ClinicalTrials.gov public API (clinicaltrials.gov/api/v2), run by the U.S. National Library of Medicine. We only display that public information; we do not add opinions, endorsements, or any other intent. 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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

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

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 19, 2023 (Actual)
Primary completion
Oct 18, 2024 (Actual)
Completion
Oct 18, 2024 (Actual)
Last update posted
Mar 26, 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 26, 2025 · Synced Nov 11, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.