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A Study to Assess the Safety and Efficacy of Brexanolone in the Treatment of Adolescent Female Subjects With Postpartum Depression

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ClinicalTrials.gov Identifier: NCT03665038
Recruitment Status : Recruiting
First Posted : September 11, 2018
Last Update Posted : October 2, 2019
Sponsor:
Information provided by (Responsible Party):
Sage Therapeutics

Study Description
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Brief Summary:
This study is a multi-center, double-blind, placebo-controlled study evaluating the efficacy, safety, tolerability, and pharmacokinetics of Brexanolone in the treatment of adolescent female subjects with postpartum depression.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy, 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 : June 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


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


Outcome Measures
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Primary Outcome Measures :
  1. Evaluate the effects of brexanolone on depressive symptoms as measured by the Hamilton Rating Scale for Depression (HAM-D) when administered to adolescent female subjects diagnosed with PPD. [ Time Frame: Hour 60 ]

Secondary Outcome Measures :
  1. Assess the effects of brexanolone on the Clinical Global Impression (CGI)-Improvement score. [ Time Frame: 90 days ]
  2. Evaluate the safety and tolerability of brexanolone based on adverse events and serious adverse events. [ Time Frame: 90 days ]
  3. Evaluate the safety and tolerability of brexanolone based on electrocardiograms (ECGs). [ Time Frame: 14 days ]
    Observed values and change from baseline in ECGs in patients with PPD.

  4. Evaluate the safety and tolerability of brexanolone based on physical examination findings. [ Time Frame: 90 days ]
    Observed values and changes fro baseline in physical examinations in patients with PPD.

  5. Evaluate the safety and tolerability of brexanolone based on concomitant medication use. [ Time Frame: 90 days ]
    Number of participants with concomitant medications usage in patients with PPD.

  6. Evaluate the safety and tolerability of brexanolone based on Columbia-Suicide Severity Rating Scale. [ Time Frame: 90 days ]
  7. Evaluate the safety and tolerability of brexanolone based on heart rate. [ Time Frame: 90 days ]
  8. Evaluate the safety and tolerability of brexanolone based on blood pressure. [ Time Frame: 90 days ]
  9. Evaluate the safety and tolerability of brexanolone based on respiratory rate. [ Time Frame: 90 days ]
  10. Evaluate the safety and tolerability of brexanolone based on oral temperature. [ Time Frame: 90 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. Subject 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. Subject 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


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
Chandler, Arizona, United States, 85226
Contact       clinicaltrialsinquiry@sagerx.com   
United States, Arkansas
Sage Investigational Site Recruiting
Rogers, 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
Pensacola, Florida, United States, 32502
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Pinellas Park, Florida, United States, 33782
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, Kansas
Sage Investigational Site Recruiting
Wichita, Kansas, United States, 67226
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   
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   
United States, Utah
Sage Investigational Site Recruiting
Salt Lake City, Utah, United States, 84124
Contact       clinicaltrialsinquiry@sagerx.com   
Sponsors and Collaborators
Sage Therapeutics
More Information
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Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

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Responsible Party: Sage Therapeutics
ClinicalTrials.gov Identifier: NCT03665038     History of Changes
Other Study ID Numbers: 547-PPD-304
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: October 2, 2019
Last Verified: October 2019

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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
Pregnanolone
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs