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A Study to Assess the Safety of Brexanolone in the Treatment of Adolescent Female Participants With Postpartum Depression (PPD)

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ClinicalTrials.gov Identifier: NCT03665038
Recruitment Status : Completed
First Posted : September 11, 2018
Last Update Posted : February 9, 2021
Sponsor:
Information provided by (Responsible Party):
Sage Therapeutics

Study Description
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Brief Summary:
This is a multi-center study evaluating the safety, tolerability, and pharmacokinetics of brexanolone in the treatment of adolescent female participants with postpartum depression.

Condition or disease Intervention/treatment Phase
Post Partum Depression Drug: Brexanolone Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-Label Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Brexanolone in the Treatment of Adolescent Female Subjects With Postpartum Depression
Actual Study Start Date : May 17, 2018
Actual Primary Completion Date : January 8, 2021
Actual Study Completion Date : January 8, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Brexanolone

Arms and Interventions
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Arm Intervention/treatment
Experimental: Brexanolone Drug: Brexanolone
Brexanolone


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Up to 30 days ]
    An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. A TEAE is an AE that occurs after the first administration of a study drug.


Secondary Outcome Measures :
  1. Area Under the Concentration-time Curve (AUC) from Time Zero to 60 Hours (AUC0-60) [ Time Frame: 3 days ]
  2. AUC from Time Zero to Infinity (AUC∞) [ Time Frame: 3 days ]
  3. Maximum (Peak) Plasma Concentration (Cmax) [ Time Frame: 3 days ]
  4. Time at Maximum (Peak) Plasma Concentration (tmax) [ Time Frame: 3 days ]
  5. Steady-state Drug Concentration in Plasma During Constant-rate Infusion (Css) [ Time Frame: 3 days ]
  6. Average Drug Concentration in Plasma at Steady State During a Dosing Interval (Cavg) [ Time Frame: 3 days ]

Eligibility Criteria
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Ages Eligible for Study:   15 Years to 17 Years   (Child)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  1. Participant has had a major depressive episode that began no earlier than the third trimester and no later than the first 4 weeks following delivery, as diagnosed by Structured Clinical Interview for DSM-5 Disorders (SCID-5).
  2. Participant is ≤6 months postpartum at screening.

Key Exclusion Criteria:

  1. Active psychosis
  2. Attempted suicide during current episode of PPD
  3. Medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.

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): NCT03665038


Locations
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United States, Arizona
Sage Investigational Site
Tempe, Arizona, United States, 85226
United States, Arkansas
Sage Investigational Site
North Little Rock, Arkansas, United States, 72758
United States, Florida
Sage Investigational Site
Miramar, Florida, United States, 33029
Sage Investigational Site
Orlando, Florida, United States, 32807
Sage Investigational Site
Pensacola, Florida, United States, 32502
Sage Investigational Site
Pinellas Park, Florida, United States, 33782
Sage Investigational Site
Pompano Beach, Florida, United States, 33060
United States, Georgia
Sage Investigational Site
Atlanta, Georgia, United States, 30331
Sage Investigational Site
Decatur, Georgia, United States, 30030
United States, Kentucky
Sage Investigational Site
Edgewood, Kentucky, United States, 41017
Sage Investigational Site
Owensboro, Kentucky, United States, 42303
United States, Mississippi
Sage Investigational Site
Flowood, Mississippi, United States, 39232
Sage Investigational Site
Jackson, Mississippi, United States, 39216
United States, North Carolina
Sage Investigational Site
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Sage Investigational Site
Middleburg Heights, Ohio, United States, 44130
United States, Texas
Sage Investigational Site
Houston, Texas, United States, 77058
Sage Investigational Site
League City, Texas, United States, 77573
Sponsors and Collaborators
Sage Therapeutics
More Information
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Additional Information:

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Responsible Party: Sage Therapeutics
ClinicalTrials.gov Identifier: NCT03665038    
Other Study ID Numbers: 547-PPD-304
2017-004356-34 ( EudraCT Number )
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: February 9, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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
Additional relevant MeSH terms:
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Depression, Postpartum
Depression
Depressive Disorder
Behavioral Symptoms
 Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications