Clinical trial NCT05655507: Zuranolone Pharmacokinetics (PK) and Safety Study Adolescent Participants With Major Depressive Disorder (MDD)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder
MDD
Depression
Pediatrics
Child
Adolescent
SAGE-217
Zuranolone
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2022-12-19
Enrollment: 19
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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/exclusion criteria may apply.

Primary outcomes:
measure: Plasma Concentrations of Zuranolone
timeFrame: At multiple timepoints post dose on Days 1, 8 and 15
Secondary outcomes:
measure: Percentage of Participants With at Least one Treatment Emergent Adverse Event (TEAE)
timeFrame: Up to 42 days
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Sage Investigational Site
state: Georgia
city: Decatur
country: United States
facility: Sage Investigational Site
state: Georgia
city: Flowood
country: United States
facility: Sage Investigational Site
state: Mississippi
city: Cincinnati
country: United States
facility: Sage Investigational Site
state: Ohio
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: