- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03924492
Expanded Access Protocol of ZULRESSO™ (Brexanolone) Injection for Adult Patients With Postpartum Depression
June 26, 2019 updated by: Sage Therapeutics
Expanded Access Protocol of ZULRESSO for Adult Patients With Postpartum Depression
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.
Study Overview
Status
Approved for marketing
Conditions
Intervention / Treatment
Study Type
Expanded Access
Expanded Access Type
- Intermediate-size Population
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Subject has signed an informed consent form prior to any study-specific procedures being performed
- Subject is an ambulatory female at least 18 years of age
- Subject agrees to adhere to the study requirements
- Subject agrees not to be the primary caregiver of any dependents during the infusion
- Subject must have a negative pregnancy test on Day 1 prior to the start of the ZULRESSO infusion
- Subject has a current diagnosis of PPD, as assessed by the Investigator
Exclusion Criteria:
- Subject has end stage renal disease
- Subject has a known allergy to progesterone or allopregnanolone
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
April 18, 2019
First Submitted That Met QC Criteria
April 18, 2019
First Posted (Actual)
April 23, 2019
Study Record Updates
Last Update Posted (Actual)
June 28, 2019
Last Update Submitted That Met QC Criteria
June 26, 2019
Last Verified
June 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Mood Disorders
- Pregnancy Complications
- Puerperal Disorders
- Depression
- Depressive Disorder
- Depression, Postpartum
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Anesthetics
- GABA Modulators
- GABA Agents
- Neurosteroids
- Brexanolone
- Pregnanolone
Other Study ID Numbers
- 547-PPD-401
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Postpartum Depression
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University of British ColumbiaCanadian Institutes of Health Research (CIHR); Women's Health Research Institute...CompletedPostpartum Depression | Perinatal Disorder | Postpartum Disorder | Perinatal Depression | Postpartum Anxiety | Postnatal DepressionCanada
-
University of CoimbraEnrolling by invitationPostPartum DepressionPortugal
-
University of MinnesotaNational Institute of Mental Health (NIMH)Completed
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Sage TherapeuticsCompletedSevere Postpartum DepressionUnited States
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Women's College HospitalCanadian Institutes of Health Research (CIHR); Michael Garron HospitalCompletedPostpartum Depression | Postpartum Anxiety | Postpartum Blues | Postpartum Mood DisorderCanada
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Gazi UniversityCompletedPostpartum Depression | Postpartum AdaptationTurkey
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British Columbia Children's HospitalActive, not recruiting
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University of RochesterMae Stone Goode FoundationCompletedPostpartum Depression | Postpartum AnxietyUnited States
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Hacettepe UniversityCompletedQuality of Life | Postpartum Depression | Nursing Caries | Nurse's Role | Postpartum Disorder | Postpartum AnxietyTurkey
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