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

Major Depressive Disorder Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05655507
• Other study ID #: 217-CLP-118
• Status: Recruiting
• Phase: Phase 1
• Start date: April 19, 2023
• Est. completion date: October 2024

Study information

• Verified date: December 2023
• Source: Sage Therapeutics
• Contact: Carrie Vaudreuil, MD
• Phone: 857-259-4766
• Email: carrie.vaudreuil[@]sagerx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: October 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 12 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• Zuranolone
Administered as capsules

Locations

Country	Name	City	State
United States	Sage Investigational Site	Atlanta	Georgia
United States	Sage Investigational Site	Cincinnati	Ohio
United States	Sage Investigational Site	Decatur	Georgia
United States	Sage Investigational Site	Flowood	Mississippi

Sponsors (2)

Lead Sponsor	Collaborator
Sage Therapeutics	Biogen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma Concentrations of Zuranolone	PK Parameters of Zuranolone will be assessed.	At multiple timepoints post dose on Days 1, 8 and 15
Secondary	Percentage of Participants With at Least one Treatment Emergent Adverse Event (TEAE)		Up to 42 days