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SAGE-217 Pharmacokinetics (PK) and Safety Study Pediatric Participants With Major Depressive Disorder (MDD)

Primary Purpose

Major Depressive Disorder

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SAGE-217
Sponsored by
Sage Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Major Depressive Disorder, MDD, Depression, Pediatrics, Child, Adolescent, SAGE-217, Zuranolone

Eligibility Criteria

7 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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. 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.

Sites / Locations

  • Sage Investigational SiteRecruiting
  • Sage Investigational SiteRecruiting
  • Sage Investigational SiteRecruiting
  • Sage Investigational SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Part A: SAGE-217

Part B: SAGE-217

Arm Description

Adolescents (12-17 years of age) will be enrolled to receive SAGE-217 orally, during the daytime on Day 1 and in the evening on Days 2 to 14. Participants with a body weight greater than or equal to 54 kilograms (kg) will receive 50 mg, and participants with a body weight less than 54 kg will receive 40 mg.

Children (7-11 years of age) will be enrolled to receive SAGE-217 orally, during the daytime on Day 1 and in the evening on Days 2 to 14. The dose to be administered will be determined after review of safety and PK data in Part A.

Outcomes

Primary Outcome Measures

Plasma Concentrations of SAGE-217
PK Parameters of SAGE-217 will be assessed.

Secondary Outcome Measures

Percentage of Participants With at Least one Treatment Emergent Adverse Event (TEAE)

Full Information

First Posted
December 9, 2022
Last Updated
June 22, 2023
Sponsor
Sage Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT05655507
Brief Title
SAGE-217 Pharmacokinetics (PK) and Safety Study Pediatric Participants With Major Depressive Disorder (MDD)
Official Title
A Phase 1, 2-Part Study to Evaluate the Pharmacokinetics and Safety of SAGE-217 in Adolescents (Part A: 12 to 17 Years of Age) and Children (Part B: 7 to 11 Years of Age) With Major Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 19, 2023 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sage Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary purpose of this study is to evaluate the pharmacokinetics and safety of SAGE-217 in adolescents (ages 12 to 17 years) and children (ages 7 to 11 years) with MDD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Major Depressive Disorder, MDD, Depression, Pediatrics, Child, Adolescent, SAGE-217, Zuranolone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Part A: SAGE-217
Arm Type
Experimental
Arm Description
Adolescents (12-17 years of age) will be enrolled to receive SAGE-217 orally, during the daytime on Day 1 and in the evening on Days 2 to 14. Participants with a body weight greater than or equal to 54 kilograms (kg) will receive 50 mg, and participants with a body weight less than 54 kg will receive 40 mg.
Arm Title
Part B: SAGE-217
Arm Type
Experimental
Arm Description
Children (7-11 years of age) will be enrolled to receive SAGE-217 orally, during the daytime on Day 1 and in the evening on Days 2 to 14. The dose to be administered will be determined after review of safety and PK data in Part A.
Intervention Type
Drug
Intervention Name(s)
SAGE-217
Other Intervention Name(s)
Zuranolone
Intervention Description
Administered as capsules
Primary Outcome Measure Information:
Title
Plasma Concentrations of SAGE-217
Description
PK Parameters of SAGE-217 will be assessed.
Time Frame
At multiple timepoints post dose on Days 1, 8 and 15
Secondary Outcome Measure Information:
Title
Percentage of Participants With at Least one Treatment Emergent Adverse Event (TEAE)
Time Frame
Up to 42 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carrie Vaudreuil, MD
Phone
857-259-4766
Email
carrie.vaudreuil@sagerx.com
Facility Information:
Facility Name
Sage Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.

Learn more about this trial

SAGE-217 Pharmacokinetics (PK) and Safety Study Pediatric Participants With Major Depressive Disorder (MDD)

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