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Trial record 1 of 1 for:    547-PPD-304
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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 : Recruiting
First Posted : September 11, 2018
Last Update Posted : April 2, 2020
Sponsor:
Information provided by (Responsible Party):
Sage Therapeutics

Tracking Information
First Submitted Date  ICMJE April 30, 2018
First Posted Date  ICMJE September 11, 2018
Last Update Posted Date April 2, 2020
Actual Study Start Date  ICMJE May 17, 2018
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 14, 2020)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 6, 2018)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 14, 2020)
  • Area Under the Concentration-time Curve (AUC) from Time Zero to 60 Hours (AUC0-60) [ Time Frame: 3 days ]
  • AUC from Time Zero to Infinity (AUC∞) [ Time Frame: 3 days ]
  • Maximum (Peak) Plasma Concentration (Cmax) [ Time Frame: 3 days ]
  • Time at Maximum (Peak) Plasma Concentration (tmax) [ Time Frame: 3 days ]
  • Steady-state Drug Concentration in Plasma During Constant-rate Infusion (Css) [ Time Frame: 3 days ]
  • Average Drug Concentration in Plasma at Steady State During a Dosing Interval (Cavg) [ Time Frame: 3 days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2018)
  • Assess the effects of brexanolone on the Clinical Global Impression (CGI)-Improvement score. [ Time Frame: 90 days ]
  • Evaluate the safety and tolerability of brexanolone based on adverse events and serious adverse events. [ Time Frame: 90 days ]
  • 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.
  • 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.
  • 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.
  • Evaluate the safety and tolerability of brexanolone based on Columbia-Suicide Severity Rating Scale. [ Time Frame: 90 days ]
  • Evaluate the safety and tolerability of brexanolone based on heart rate. [ Time Frame: 90 days ]
  • Evaluate the safety and tolerability of brexanolone based on blood pressure. [ Time Frame: 90 days ]
  • Evaluate the safety and tolerability of brexanolone based on respiratory rate. [ Time Frame: 90 days ]
  • Evaluate the safety and tolerability of brexanolone based on oral temperature. [ Time Frame: 90 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Assess the Safety of Brexanolone in the Treatment of Adolescent Female Participants With Postpartum Depression (PPD)
Official Title  ICMJE A Multicenter, Open-Label Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Brexanolone in the Treatment of Adolescent Female Subjects With Postpartum Depression
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Post Partum Depression
Intervention  ICMJE Drug: Brexanolone
Brexanolone
Study Arms  ICMJE Experimental: Brexanolone
Intervention: Drug: Brexanolone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 14, 2020)
20
Original Estimated Enrollment  ICMJE
 (submitted: September 6, 2018)
40
Estimated Study Completion Date  ICMJE September 2020
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 15 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kemi Bankole, MD 617-299-8380 Kemi.Bankole@sagerx.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03665038
Other Study ID Numbers  ICMJE 547-PPD-304
2017-004356-34 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.
Responsible Party Sage Therapeutics
Study Sponsor  ICMJE Sage Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Sage Therapeutics
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP