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Brexanolone

DRUG9 trials

Sponsors

Supernus Pharmaceuticals, Inc., Sage Therapeutics, Yale University, University of North Carolina, Chapel Hill, Brigham and Women's Hospital

Conditions

Acute Respiratory Distress SyndromeAlcohol Use DisorderAlcohol Use Disorder (AUD)COVID-19DepressionPTSDPost Partum DepressionPost Traumatic Stress Disorder (PTSD)

Early Phase 1

Effects Zulresso on Postpartum Psychosis
CompletedNCT05314153
University of North Carolina, Chapel HillPostpartum Psychosis
Start: 2022-02-23End: 2024-06-01Updated: 2024-08-26

Phase 1

Utility of Brexanolone to Target Stress-induced Alcohol Use Among Men and Women With Posttraumatic Stress Disorder
Active, not recruitingNCT05223829
Yale UniversityAlcohol Use Disorder, PTSD
Start: 2023-08-01End: 2025-12-31Target: 25Updated: 2025-10-14

Phase 2

An Open-Label Study Evaluating Brexanolone in Adults With Tinnitus
CompletedNCT05645432
Supernus Pharmaceuticals, Inc.Tinnitus
Start: 2023-05-10End: 2023-11-21Updated: 2025-09-15
Brexanolone to Target Concurrent PTSD and Stress Induced Alcohol Use in Veterans: A Dose Finding Study
Not yet recruitingNCT06580444
Pharmacotherapies for Alcohol and Substance Use Disorders AllianceAlcohol Use Disorder (AUD), Post Traumatic Stress Disorder (PTSD)
Start: 2025-07-28End: 2027-03-19Target: 40Updated: 2025-05-31

Phase 3

A Study to Assess the Safety of Brexanolone in the Treatment of Adolescent Female Participants With Postpartum Depression (PPD)
CompletedNCT03665038
Supernus Pharmaceuticals, Inc.Post Partum Depression
Start: 2018-09-07End: 2021-01-08Updated: 2025-09-15
A Study of Brexanolone for Acute Respiratory Distress Syndrome (ARDS) Due to Coronavirus Disease 2019 (COVID-19)
TerminatedNCT04537806
Sage TherapeuticsAcute Respiratory Distress Syndrome, COVID-19
Start: 2020-12-18End: 2021-07-01Updated: 2022-08-19

Phase 4

A Study to Evaluate Multimodal Neuroimaging Parameters in Women With Postpartum Depression Who Are Receiving ZULRESSO™ (Brexanolone)
WithdrawnNCT04273191
Sage TherapeuticsPostpartum Depression
Start: 2020-02-29End: 2021-08-31Updated: 2020-08-18
Study on Allopregnanolone and Depression in Perimenopausal Women
TerminatedNCT05329779
Brigham and Women's HospitalDepression
Start: 2022-11-04End: 2023-07-18Updated: 2026-01-22

Unknown Phase

Dynamic Neural Mechanisms of Brexanolone-induced Antidepressant Effects in Postpartum Depression
CompletedNCT05543746
University of North Carolina, Chapel HillPostpartum Depression
Start: 2022-08-05End: 2023-11-15Updated: 2025-01-28

Related Papers

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