Major Depressive Disorder
Conditions
Keywords
Major Depressive Disorder, MDD, Depression, Pediatrics, Child, Adolescent, SAGE-217, Zuranolone
Brief 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.
Interventions
DRUGZuranolone
Administered as capsules
Sponsors
Biogen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
12 Years to 17 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Concentrations of Zuranolone | At multiple timepoints post dose on Days 1, 8 and 15 | PK Parameters of Zuranolone will be assessed. |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants With at Least one Treatment Emergent Adverse Event (TEAE) | Up to 42 days |
Countries
United States
Outcome results
None listed