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Showing 1–21 of 21 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: Brexanolone Clear all
Completed Phase 4 Interventional Results available

A Study To Assess The Safe-Use Conditions For Administration of ZULRESSO® in a Home Setting

NCT05059600
View directory record Official record
Conditions
Postpartum Depression
Interventions
ZULRESSO®
Drug
Lead sponsor
Supernus Pharmaceuticals, Inc.
Industry
Eligibility
18 Years and older · Female only
Enrollment
52 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2022
U.S. locations
6
States / cities
Culver City, California • Miramar, Florida • Pompano Beach, Florida + 2 more
Source: ClinicalTrials.gov public record
Updated Sep 14, 2025 · Synced Sep 1, 2026, 10:42 AM EDT
Terminated Phase 4 Interventional Results available

Study on Allopregnanolone and Depression in Perimenopausal Women

NCT05329779
View directory record Official record
Conditions
Depression
Interventions
brexanolone, placebo
Drug
Lead sponsor
Brigham and Women's Hospital
Other
Eligibility
40 Years to 60 Years · Female only
Enrollment
2 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2023
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Jan 21, 2026 · Synced Sep 1, 2026, 10:42 AM EDT
Completed Phase 2 Interventional Results available

Evaluate SAGE-547 in Participants With Essential Tremor

NCT02277106
View directory record Official record
Conditions
Essential Tremor
Interventions
SAGE-547, Placebo
Drug
Lead sponsor
Sage Therapeutics
Industry
Eligibility
35 Years to 75 Years
Enrollment
25 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2015
U.S. locations
2
States / cities
Bingham Farms, Michigan • Raleigh, North Carolina
Source: ClinicalTrials.gov public record
Updated Jun 28, 2022 · Synced Sep 1, 2026, 10:42 AM EDT
Terminated Phase 4 Interventional

An Open Label Pilot Study of IV Brexanolone for the Treatment of Post-Traumatic Stress Disorder

NCT05254405
View directory record Official record
Conditions
Post-Traumatic Stress Disorder
Interventions
Brexanolone Injection [Zulresso]
Drug
Lead sponsor
Donald Jeffrey Newport
Other
Eligibility
18 Years to 50 Years · Female only
Enrollment
10 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2025
U.S. locations
1
States / cities
Austin, Texas
Source: ClinicalTrials.gov public record
Updated May 21, 2026 · Synced Sep 1, 2026, 10:42 AM EDT
Completed Early Phase 1 Interventional

Effects Zulresso on Postpartum Psychosis

NCT05314153
View directory record Official record
Conditions
Postpartum Psychosis
Interventions
Brexanolone
Drug
Lead sponsor
University of North Carolina, Chapel Hill
Other
Eligibility
18 Years to 45 Years · Female only
Enrollment
10 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2024
U.S. locations
1
States / cities
Chapel Hill, North Carolina
Source: ClinicalTrials.gov public record
Updated Aug 25, 2024 · Synced Sep 1, 2026, 10:42 AM EDT
Completed Phase 2 Interventional Results available

An Open-Label Study Evaluating Brexanolone in Adults With Tinnitus

NCT05645432
View directory record Official record
Conditions
Tinnitus
Interventions
Brexanolone
Drug
Lead sponsor
Supernus Pharmaceuticals, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
10 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023
U.S. locations
2
States / cities
Atlanta, Georgia • Iowa City, Iowa
Source: ClinicalTrials.gov public record
Updated Sep 14, 2025 · Synced Sep 1, 2026, 10:42 AM EDT
Completed Phase 3 Interventional

A Study to Assess the Safety and Efficacy of Oral LPCN 1154A in Women With Severe PPD

NCT06979544
View directory record Official record
Conditions
Depression, Postpartum, Depression, Post-Partum, Postpartum Depression (PPD), Post-Natal Depression, Peripartum Depression, Postnatal Depression
Interventions
LPCN 1154A, Placebo
Drug
Lead sponsor
Lipocine Inc.
Industry
Eligibility
15 Years to 45 Years · Female only
Enrollment
90 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2026
U.S. locations
18
States / cities
Anahiem, California • Canoga Park, California • Miami, Florida + 14 more
Source: ClinicalTrials.gov public record
Updated Feb 23, 2026 · Synced Sep 1, 2026, 10:42 AM EDT
Terminated Phase 3 Interventional Results available

A Study of Brexanolone for Acute Respiratory Distress Syndrome (ARDS) Due to Coronavirus Disease 2019 (COVID-19)

NCT04537806
View directory record Official record
Conditions
Acute Respiratory Distress Syndrome, COVID-19
Interventions
Brexanolone, Placebo
Drug
Lead sponsor
Sage Therapeutics
Industry
Eligibility
18 Years and older
Enrollment
29 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2021
U.S. locations
9
States / cities
Fresno, California • Augusta, Georgia • Boston, Massachusetts + 6 more
Source: ClinicalTrials.gov public record
Updated Aug 18, 2022 · Synced Sep 1, 2026, 10:42 AM EDT
Completed No phase listed Observational Accepts healthy volunteers Results available

Dynamic Neural Mechanisms of Brexanolone-induced Antidepressant Effects in Postpartum Depression

NCT05543746
View directory record Official record
Conditions
Postpartum Depression
Interventions
Brexanolone
Drug
Lead sponsor
University of North Carolina, Chapel Hill
Other
Eligibility
18 Years to 45 Years · Female only
Enrollment
10 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2022 – 2023
U.S. locations
1
States / cities
Chapel Hill, North Carolina
Source: ClinicalTrials.gov public record
Updated Jan 27, 2025 · Synced Sep 1, 2026, 10:42 AM EDT
Recruiting Phase 2 Interventional Accepts healthy volunteers

Facilitation of Extinction Retention and Reconsolidation Blockade by IV Allopregnanolone in PTSD.

NCT07079761
View directory record Official record
Conditions
Post Traumatic Stress Disorder
Interventions
Experiment 1. Three-day aversive conditioning, extinction, and extinction retention testing paradigm, Allopregnanolone (Allo) with 6% USP Dexolve (sulfobutyl ether-beta-cyclodextrin sodium salt) in 0.9% saline for IV infusion will be provided by the University of California, Davis, GMP manufacturer., Matching IV Placebo, Experiment 2. Three-day aversive conditioning, reconsolidation blockade, and testing paradigm
Behavioral · Drug · Other
Lead sponsor
Massachusetts General Hospital
Other
Eligibility
18 Years to 55 Years
Enrollment
96 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2025 – 2027
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Nov 4, 2025 · Synced Sep 1, 2026, 10:42 AM EDT
Completed Phase 3 Interventional Results available

A Study to Assess the Safety of Brexanolone in the Treatment of Adolescent Female Participants With Postpartum Depression (PPD)

NCT03665038
View directory record Official record
Conditions
Post Partum Depression
Interventions
Brexanolone
Drug
Lead sponsor
Supernus Pharmaceuticals, Inc.
Industry
Eligibility
15 Years to 17 Years · Female only
Enrollment
28 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2021
U.S. locations
17
States / cities
Tempe, Arizona • North Little Rock, Arkansas • Miramar, Florida + 14 more
Source: ClinicalTrials.gov public record
Updated Sep 14, 2025 · Synced Sep 1, 2026, 10:42 AM EDT
Completed Phase 2 Interventional Results available

Evaluate SAGE-547 in Female Participants With Severe Postpartum Depression

NCT02285504
View directory record Official record
Conditions
Postpartum Depression
Interventions
SAGE-547
Drug
Lead sponsor
Supernus Pharmaceuticals, Inc.
Industry
Eligibility
18 Years to 45 Years · Female only
Enrollment
4 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015
U.S. locations
1
States / cities
Chapel Hill, North Carolina
Source: ClinicalTrials.gov public record
Updated Sep 14, 2025 · Synced Sep 1, 2026, 10:42 AM EDT
Active, not recruiting Phase 1 Interventional

Utility of Brexanolone to Target Stress-induced Alcohol Use Among Men and Women With Posttraumatic Stress Disorder

NCT05223829
View directory record Official record
Conditions
PTSD, Alcohol Use Disorder
Interventions
Brexanolone
Drug
Lead sponsor
Yale University
Other
Eligibility
21 Years to 55 Years
Enrollment
25 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2025
U.S. locations
1
States / cities
New Haven, Connecticut
Source: ClinicalTrials.gov public record
Updated Oct 13, 2025 · Synced Sep 1, 2026, 10:42 AM EDT
Completed Phase 3 Interventional Results available

A Study to Evaluate Safety and Efficacy of SAGE-547 in Participants With Moderate Postpartum Depression (547-PPD-202C)

NCT02942017
View directory record Official record
Conditions
Postpartum Depression
Interventions
Placebo, SAGE-547 90 μg/kg/h
Drug
Lead sponsor
Supernus Pharmaceuticals, Inc.
Industry
Eligibility
18 Years to 45 Years · Female only
Enrollment
108 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2017
U.S. locations
32
States / cities
Chandler, Arizona • Rogers, Arkansas • Lemon Grove, California + 28 more
Source: ClinicalTrials.gov public record
Updated Sep 14, 2025 · Synced Sep 1, 2026, 10:42 AM EDT
Completed Phase 1Phase 2 Interventional Results available

Study to Evaluate SAGE-547 Injection as Adjunctive Therapy for the Treatment of Super-Refractory Status Epilepticus

NCT02052739
View directory record Official record
Conditions
Super-refractory Status Epilepticus
Interventions
SAGE-547
Drug
Lead sponsor
Supernus Pharmaceuticals, Inc.
Industry
Eligibility
2 Years and older
Enrollment
25 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2015
U.S. locations
17
States / cities
Birmingham, Alabama • Sarasota, Florida • Chicago, Illinois + 13 more
Source: ClinicalTrials.gov public record
Updated Sep 14, 2025 · Synced Sep 1, 2026, 10:42 AM EDT
Completed Phase 2 Interventional Results available

A Study to Evaluate SAGE-547 in Participants With Severe Postpartum Depression

NCT02614547
View directory record Official record
Conditions
Severe Postpartum Depression
Interventions
SAGE-547, Placebo
Drug
Lead sponsor
Supernus Pharmaceuticals, Inc.
Industry
Eligibility
18 Years to 45 Years · Female only
Enrollment
21 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2016
U.S. locations
4
States / cities
Atlanta, Georgia • Worcester, Massachusetts • Chapel Hill, North Carolina + 1 more
Source: ClinicalTrials.gov public record
Updated Sep 14, 2025 · Synced Sep 1, 2026, 10:42 AM EDT
Completed Phase 3 Interventional Results available

A Study to Evaluate Efficacy and Safety of SAGE-547 in Participants With Severe Postpartum Depression (547-PPD-202B)

NCT02942004
View directory record Official record
Conditions
Postpartum Depression
Interventions
Placebo, SAGE-547 60 μg/kg/h, SAGE-547 90 μg/kg/h
Drug
Lead sponsor
Supernus Pharmaceuticals, Inc.
Industry
Eligibility
18 Years to 45 Years · Female only
Enrollment
138 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2017
U.S. locations
32
States / cities
Chandler, Arizona • Rogers, Arkansas • Lemon Grove, California + 27 more
Source: ClinicalTrials.gov public record
Updated Oct 13, 2025 · Synced Sep 1, 2026, 10:42 AM EDT
Completed Phase 2 Interventional Results available

Treatment of Fragile-X Associated Tremor/Ataxia Syndrome (FXTAS) With Allopregnanolone

NCT02603926
View directory record Official record
Conditions
Fragile X-associated Tremor/Ataxia Syndrome
Interventions
Allopregnanolone
Drug
Lead sponsor
Randi J. Hagerman, MD
Other
Eligibility
50 Years to 85 Years
Enrollment
6 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2017
U.S. locations
1
States / cities
Sacramento, California
Source: ClinicalTrials.gov public record
Updated Dec 5, 2018 · Synced Sep 1, 2026, 10:42 AM EDT
Recruiting No phase listed Observational Accepts healthy volunteers

National Pregnancy Registry for Psychiatric Medications

NCT01246765
View directory record Official record
Conditions
Pregnant Women, Psychotropic Drugs
Interventions
Not listed
Lead sponsor
Massachusetts General Hospital
Other
Eligibility
18 Years to 45 Years · Female only
Enrollment
5,000 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2008 – 2033
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Oct 23, 2025 · Synced Sep 1, 2026, 10:42 AM EDT
Terminated Phase 2 Interventional Results available

Pharmacokinetic Study for IV Allopregnanolone

NCT04468360
View directory record Official record
Conditions
Pharmacokinetic Study, Post Traumatic Stress Disorder
Interventions
PK-1 Good Manufacturing Practices (GMP) allopregnanolone (Allo) with Dexolve in 0.9% saline for infusion manufactured by the University of California, Davis, PK-2 GMP allopregnanolone (Allo) with Dexolve in 0.9% saline for infusion manufactured by the University of California, Davis.
Drug
Lead sponsor
Boston University
Other
Eligibility
18 Years to 55 Years
Enrollment
11 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2025
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Jun 1, 2026 · Synced Sep 1, 2026, 10:42 AM EDT
Completed Phase 3 Interventional Results available

A Study With SAGE-547 for Super-Refractory Status Epilepticus

NCT02477618
View directory record Official record
Conditions
Super-Refractory Status Epilepticus
Interventions
SAGE-547, Placebo
Drug
Lead sponsor
Supernus Pharmaceuticals, Inc.
Industry
Eligibility
2 Years and older
Enrollment
132 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2017
U.S. locations
100
States / cities
Birmingham, Alabama • Mobile, Alabama • Phoenix, Arizona + 76 more
Source: ClinicalTrials.gov public record
Updated Oct 13, 2025 · Synced Sep 1, 2026, 10:42 AM EDT