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Trial record 14 of 14 for:    Sage 217
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Zuranolone Pharmacokinetics (PK) and Safety Study Adolescent Participants With Major Depressive Disorder (MDD)

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ClinicalTrials.gov Identifier: NCT05655507
Recruitment Status : Recruiting
First Posted : December 19, 2022
Last Update Posted : December 8, 2023
Sponsor:
Collaborator:
Biogen
Information provided by (Responsible Party):
Sage Therapeutics

Study Description
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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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Zuranolone Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 19, 2023
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : October 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: Zuranolone
Administered as capsules
Other Name: SAGE-217, BIIB125


Outcome Measures
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Primary Outcome Measures :
  1. Plasma Concentrations of Zuranolone [ Time Frame: At multiple timepoints post dose on Days 1, 8 and 15 ]
    PK Parameters of Zuranolone will be assessed.


Secondary Outcome Measures :
  1. Percentage of Participants With at Least one Treatment Emergent Adverse Event (TEAE) [ Time Frame: Up to 42 days ]

Eligibility Criteria
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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05655507


Contacts
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Contact: Carrie Vaudreuil, MD 857-259-4766 carrie.vaudreuil@sagerx.com

Locations
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United States, Georgia
Sage Investigational Site Recruiting
Atlanta, Georgia, United States, 30331
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Decatur, Georgia, United States, 30030
Contact       clinicaltrialsinquiry@sagerx.com   
United States, Mississippi
Sage Investigational Site Recruiting
Flowood, Mississippi, United States, 39232
Contact       clinicaltrialsinquiry@sagerx.com   
United States, Ohio
Sage Investigational Site Recruiting
Cincinnati, Ohio, United States, 45219
Contact       clinicaltrialsinquiry@sagerx.com   
Sponsors and Collaborators
Sage Therapeutics
Biogen
More Information
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Responsible Party: Sage Therapeutics
ClinicalTrials.gov Identifier: NCT05655507    
Other Study ID Numbers: 217-CLP-118
First Posted: December 19, 2022    Key Record Dates
Last Update Posted: December 8, 2023
Last Verified: December 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sage Therapeutics:
Major Depressive Disorder
MDD
Depression
Pediatrics
 Child
Adolescent
SAGE-217
Zuranolone
Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
 Behavioral Symptoms
Zuranolone
Antidepressive Agents
Psychotropic Drugs