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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03665038
Recruitment Status : Recruiting
First Posted : September 11, 2018
Last Update Posted : April 2, 2020
Sponsor:
Information provided by (Responsible Party):
Sage Therapeutics

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Brexanolone Drug: Brexanolone
Brexanolone




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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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.


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


Contacts
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Contact: Kemi Bankole, MD 617-299-8380 Kemi.Bankole@sagerx.com

Locations
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United States, Arizona
Sage Investigational Site Recruiting
Tempe, Arizona, United States, 85226
Contact       clinicaltrialsinquiry@sagerx.com   
United States, Arkansas
Sage Investigational Site Recruiting
North Little Rock, Arkansas, United States, 72758
Contact       clinicaltrialsinquiry@sagerx.com   
United States, Florida
Sage Investigational Site Recruiting
Miramar, Florida, United States, 33029
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Orlando, Florida, United States, 32807
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Pensacola, Florida, United States, 32502
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Pinellas Park, Florida, United States, 33782
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Pompano Beach, Florida, United States, 33060
Contact       clinicaltrialsinquiry@sagerx.com   
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, Kentucky
Sage Investigational Site Recruiting
Edgewood, Kentucky, United States, 41017
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Owensboro, Kentucky, United States, 42303
Contact       clinicaltrialsinquiry@sagerx.com   
United States, Mississippi
Sage Investigational Site Recruiting
Flowood, Mississippi, United States, 39232
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Jackson, Mississippi, United States, 39216
Contact       clinicaltrialsinquiry@sagerx.com   
United States, North Carolina
Sage Investigational Site Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact       clinicaltrialsinquiry@sagerx.com   
United States, Ohio
Sage Investigational Site Recruiting
Middleburg Heights, Ohio, United States, 44130
Contact       clinicaltrialsinquiry@sagerx.com   
United States, Texas
Sage Investigational Site Recruiting
Houston, Texas, United States, 77058
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
League City, Texas, United States, 77573
Contact       clinicaltrialsinquiry@sagerx.com   
Sponsors and Collaborators
Sage Therapeutics
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: April 2, 2020
Last Verified: April 2020
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