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Expanded Access Protocol of ZULRESSO™ (Brexanolone) Injection for Adult Patients With Postpartum Depression

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ClinicalTrials.gov Identifier: NCT03924492
Expanded Access Status : Approved for marketing
First Posted : April 23, 2019
Last Update Posted : June 28, 2019
Sponsor:
Information provided by (Responsible Party):
Sage Therapeutics

Study Description
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Brief Summary:
This is an expanded access program intended to provide access to ZULRESSO™ (brexanolone) injection for the treatment of a limited number of eligible women with postpartum depression during the period prior to commercial availability. Requests for access must be made by a healthcare provider for a specific patient based on a determination with patient that the benefits of treatment outweigh the risks and an assessment of eligibility based on program criteria. Sites with eligible patients must apply and meet requirements for participation in the expanded access program.

Condition or disease Intervention/treatment
Postpartum Depression Drug: ZULRESSO (brexanolone) injection

Study Design
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Study Type : Expanded Access
Expanded Access Type : Intermediate-size Population
Official Title: Expanded Access Protocol of ZULRESSO for Adult Patients With Postpartum Depression

Resource links provided by the National Library of Medicine

Drug Information available for: Brexanolone

Interventions
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Intervention Details:
  • Drug: ZULRESSO (brexanolone) injection
    ZULRESSO
    Other Names:
    • Brexanolone
    • SAGE-547
Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Criteria

Inclusion Criteria:

  1. Subject has signed an informed consent form prior to any study-specific procedures being performed
  2. Subject is an ambulatory female at least 18 years of age
  3. Subject agrees to adhere to the study requirements
  4. Subject agrees not to be the primary caregiver of any dependents during the infusion
  5. Subject must have a negative pregnancy test on Day 1 prior to the start of the ZULRESSO infusion
  6. Subject has a current diagnosis of PPD, as assessed by the Investigator

Exclusion Criteria:

  1. Subject has end stage renal disease
  2. Subject has a known allergy to progesterone or allopregnanolone
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Responsible Party: Sage Therapeutics
ClinicalTrials.gov Identifier: NCT03924492    
Other Study ID Numbers: 547-PPD-401
First Posted: April 23, 2019    Key Record Dates
Last Update Posted: June 28, 2019
Last Verified: June 2019
Keywords provided by Sage Therapeutics:
Expanded Access
Additional relevant MeSH terms:
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Depression, Postpartum
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications
Pregnanolone
 Brexanolone
Neurosteroids
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
GABA Modulators
GABA Agents
Anesthetics
Central Nervous System Depressants