Ignite Creation Date:
2025-12-24 @ 3:20 PM
Ignite Modification Date:
2026-01-03 @ 8:14 PM
Study NCT ID:
NCT03924492
Status:
APPROVED_FOR_MARKETING
Last Update Posted:
2025-09-15
First Post:
2019-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Expanded Access Protocol of ZULRESSO™ (Brexanolone) Injection for Adult Patients With Postpartum Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019052', 'term': 'Depression, Postpartum'}], 'ancestors': [{'id': 'D011644', 'term': 'Puerperal Disorders'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000625635', 'term': 'brexanolone'}, {'id': 'D007267', 'term': 'Injections'}], 'ancestors': [{'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'intermediate': True}}, 'statusModule': {'overallStatus': 'APPROVED_FOR_MARKETING', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'lastUpdateSubmitDate': '2025-09-11', 'studyFirstSubmitDate': '2019-04-18', 'studyFirstSubmitQcDate': '2019-04-18', 'lastUpdatePostDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-04-23', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['Expanded Access'], 'conditions': ['Postpartum Depression']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subject has signed an informed consent form prior to any study-specific procedures being performed\n2. Subject is an ambulatory female at least 18 years of age\n3. Subject agrees to adhere to the study requirements\n4. Subject agrees not to be the primary caregiver of any dependents during the infusion\n5. Subject must have a negative pregnancy test on Day 1 prior to the start of the ZULRESSO infusion\n6. Subject has a current diagnosis of PPD, as assessed by the Investigator\n\nExclusion Criteria:\n\n1. Subject has end stage renal disease\n2. Subject has a known allergy to progesterone or allopregnanolone'}, 'identificationModule': {'nctId': 'NCT03924492', 'briefTitle': 'Expanded Access Protocol of ZULRESSO™ (Brexanolone) Injection for Adult Patients With Postpartum Depression', 'organization': {'class': 'INDUSTRY', 'fullName': 'Supernus Pharmaceuticals, Inc.'}, 'officialTitle': 'Expanded Access Protocol of ZULRESSO for Adult Patients With Postpartum Depression', 'orgStudyIdInfo': {'id': '547-PPD-401'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ZULRESSO (brexanolone) injection', 'type': 'DRUG', 'otherNames': ['Brexanolone', 'SAGE-547'], 'description': 'ZULRESSO'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Supernus Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}