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

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Biogen
Study ID
NCT05655507
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
12 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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

Key Dates

Start date
Apr 19, 2023
Status verified
Mar 2025
Primary completion
Oct 18, 2024
Completion
Oct 18, 2024

Study Design

Enrollment
19 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Zuranolone
    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.

Primary Outcome Measure

Plasma Concentrations of Zuranolone [ Time Frame: At multiple timepoints post dose on Days 1, 8 and 15 ]

Locations (4)

FacilityCityStateZIPSite coordinators
Sage Investigational SiteAtlantaGeorgia30331-
Sage Investigational SiteDecaturGeorgia30030-
Sage Investigational SiteFlowoodMississippi39232-
Sage Investigational SiteCincinnatiOhio45219-

Find similar trials in Atlanta, GA

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
Sage Investigational Site· Atlanta, GASage Investigational Site· Decatur, GASage Investigational Site· Flowood, MSSage Investigational Site· Cincinnati, OH

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