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Showing 1–24 of 26 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: Allopregnanolone Clear all
Completed Not applicable Interventional Results available

Augmentation of Treatment-Resistant Depression With An Analog of the Neuroactive Steroid Allopregnanolone

NCT02900092
View directory record Official record
Conditions
Major Depressive Disorder
Interventions
Ganaxolone
Drug
Lead sponsor
Massachusetts General Hospital
Other
Eligibility
50 Years to 75 Years · Female only
Enrollment
10 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2018
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Feb 17, 2019 · Synced Sep 4, 2026, 12:03 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 4, 2026, 12:03 AM EDT
Recruiting Phase 2 Interventional

Allopregnanolone (Zuranolone) in Post-stroke Depression

NCT06759558
View directory record Official record
Conditions
Post Stroke Depression
Interventions
Zuranolone
Drug
Lead sponsor
Duke University
Other
Eligibility
21 Years to 65 Years
Enrollment
6 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2027
U.S. locations
1
States / cities
Durham, North Carolina
Source: ClinicalTrials.gov public record
Updated Sep 2, 2026 · Synced Sep 4, 2026, 12:03 AM EDT
Completed Phase 2 Interventional Results available

Neurosteroids as Novel Therapeutic Agents for Chronic Pain in OEF/OIF Veterans

NCT01898013
View directory record Official record
Conditions
Lower Back Pain
Interventions
Pregnenolone, Placebo
Drug
Lead sponsor
Durham VA Medical Center
Federal
Eligibility
18 Years to 65 Years
Enrollment
94 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2017
U.S. locations
1
States / cities
Durham, North Carolina
Source: ClinicalTrials.gov public record
Updated Oct 2, 2018 · Synced Sep 4, 2026, 12:03 AM EDT
Recruiting Phase 2 Interventional

A Study to Evaluate the Efficacy and Safety of SPT-300 (GlyphAllo) in Participants With Major Depressive Disorder, With or Without Anxious Distress (BUOY-1 Study)

NCT07065240
View directory record Official record
Conditions
Major Depressive Disorder (MDD), Major Depressive Disorder With Anxious Distress
Interventions
SPT-300, Placebo
Drug
Lead sponsor
Seaport Therapeutics
Industry
Eligibility
18 Years to 65 Years
Enrollment
360 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2027
U.S. locations
30
States / cities
Chino, California • Garden Grove, California • Glendale, California + 26 more
Source: ClinicalTrials.gov public record
Updated Aug 16, 2026 · Synced Sep 4, 2026, 12:03 AM EDT
Completed No phase listed Observational Accepts healthy volunteers

Smoking, Stress & Allopregnanolone Response

NCT02087800
View directory record Official record
Conditions
Smoking Cessation
Interventions
F phase lab session, L phase lab session
Behavioral
Lead sponsor
University of Minnesota
Other
Eligibility
18 Years to 40 Years · Female only
Enrollment
43 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2014 – 2015
U.S. locations
1
States / cities
Minneapolis, Minnesota
Source: ClinicalTrials.gov public record
Updated Nov 29, 2015 · Synced Sep 4, 2026, 12:03 AM EDT
Completed Phase 1 Interventional Results available

Effect of Allopregnanolone on Stress-induced Craving

NCT04015869
View directory record Official record
Conditions
Alcohol Use Disorder
Interventions
Allopregnanolone, Placebos
Drug
Lead sponsor
Yale University
Other
Eligibility
21 Years to 50 Years
Enrollment
10 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2023
U.S. locations
1
States / cities
West Haven, Connecticut
Source: ClinicalTrials.gov public record
Updated Aug 21, 2025 · Synced Sep 4, 2026, 12:03 AM EDT
Completed Phase 1 Interventional

Allopregnanolone for Mild Cognitive Impairment Due to Alzheimer's Disease or Mild AD

NCT02221622
View directory record Official record
Conditions
Mild Cognitive Impairment, Alzheimer Disease
Interventions
Allopregnanolone injection (intravenous solution), Placebo injection (intravenous solution)
Drug
Lead sponsor
University of Southern California
Other
Eligibility
55 Years and older
Enrollment
24 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2018
U.S. locations
1
States / cities
Los Angeles, California
Source: ClinicalTrials.gov public record
Updated Jul 4, 2019 · Synced Sep 4, 2026, 12:03 AM EDT
Recruiting Phase 4 Interventional Accepts healthy volunteers

Allopregnanolone and Dynamic GABA-A Receptor Plasticity in Selective Serotonin Reuptake Inhibitor Responsive Premenstrual Dysphoric Disorder

NCT06704594
View directory record Official record
Conditions
Premenstrual Dysphoric Disorder (PMDD)
Interventions
sertraline 50 mg daily, Placebo Oral Tablet
Drug
Lead sponsor
Johns Hopkins University
Other
Eligibility
18 Years to 50 Years · Female only
Enrollment
288 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2025 – 2029
U.S. locations
2
States / cities
Baltimore, Maryland • Charlottesville, Virginia
Source: ClinicalTrials.gov public record
Updated May 6, 2026 · Synced Sep 4, 2026, 12:03 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 4, 2026, 12:03 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 4, 2026, 12:03 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 4, 2026, 12:03 AM EDT
Terminated Phase 1 Interventional

Allopregnanolone Regenerative Therapeutic for Early Alzheimer's Disease: Intramuscular Study

NCT03748303
View directory record Official record
Conditions
Alzheimer Dementia
Interventions
Allopregnanolone
Drug
Lead sponsor
University of Arizona
Other
Eligibility
55 Years and older
Enrollment
6 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2022
U.S. locations
1
States / cities
Los Angeles, California
Source: ClinicalTrials.gov public record
Updated Mar 12, 2026 · Synced Sep 4, 2026, 12:03 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 4, 2026, 12:03 AM EDT
Completed Phase 2 Interventional Results available

Allopregnanolone for the Treatment of Traumatic Brain Injury

NCT01673828
View directory record Official record
Conditions
Traumatic Brain Injury, Posttraumatic Epilepsy
Interventions
Allopregnanolone injection, Placebo injection
Drug
Lead sponsor
Michael A. Rogawski, MD, PhD
Other
Eligibility
16 Years to 65 Years
Enrollment
13 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2016
U.S. locations
1
States / cities
Sacramento, California
Source: ClinicalTrials.gov public record
Updated Jun 27, 2017 · Synced Sep 4, 2026, 12:03 AM EDT
Active, not recruiting Phase 2 Interventional

Allopregnanolone Regenerative Therapeutic for Mild Alzheimer's Disease

NCT04838301
View directory record Official record
Conditions
Alzheimer Dementia, Late Onset Alzheimer Disease, Neurodegenerative Diseases
Interventions
Allopregnanolone, Placebo
Drug · Other
Lead sponsor
University of Arizona
Other
Eligibility
55 Years to 80 Years
Enrollment
100 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2027
U.S. locations
9
States / cities
Scottsdale, Arizona • Tucson, Arizona • Costa Mesa, California + 5 more
Source: ClinicalTrials.gov public record
Updated Jun 29, 2026 · Synced Sep 4, 2026, 12:03 AM EDT
Enrolling by invitation Phase 2 Interventional

An Open-Label Extension Study to Evaluate the Safety and Tolerability of SPT-300 (GlyphAllo) in Participants With Major Depressive Disorder, With or Without Anxious Distress (BUOY-1 OLE Study)

NCT07161700
View directory record Official record
Conditions
Major Depressive Disorder (MDD), Major Depressive Disorder With Anxious Distress
Interventions
SPT-300
Drug
Lead sponsor
Seaport Therapeutics
Industry
Eligibility
18 Years to 66 Years
Enrollment
360 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2027
U.S. locations
19
States / cities
Chino, California • Garden Grove, California • Glendale, California + 16 more
Source: ClinicalTrials.gov public record
Updated Aug 16, 2026 · Synced Sep 4, 2026, 12:03 AM EDT
Recruiting Not applicable Interventional

Study on Allopregnanolone and Depression in Women Across the Menopause Transition

NCT06238700
View directory record Official record
Conditions
Depression
Interventions
pregnenolone, placebo
Dietary Supplement · Other
Lead sponsor
Beth Israel Deaconess Medical Center
Other
Eligibility
40 Years to 60 Years · Female only
Enrollment
80 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2027
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Aug 25, 2026 · Synced Sep 4, 2026, 12:03 AM EDT
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 4, 2026, 12:03 AM EDT
Not yet recruiting Phase 2 Interventional

Allopregnanolone in Chronic Complex Traumatic Brain Injury

NCT04003285
View directory record Official record
Conditions
Traumatic Brain Injury (TBI)
Interventions
Placebo, Allopregnanolone
Drug
Lead sponsor
VA Office of Research and Development
Federal
Eligibility
21 Years to 62 Years
Enrollment
132 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2027
U.S. locations
1
States / cities
Durham, North Carolina
Source: ClinicalTrials.gov public record
Updated Jun 3, 2026 · Synced Sep 4, 2026, 12:03 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 4, 2026, 12:03 AM EDT
Completed Phase 4 Interventional Accepts healthy volunteers

Neurotrophic Factors and Depression

NCT00812994
View directory record Official record
Conditions
Depression
Interventions
Escitalopram, Placebo
Drug
Lead sponsor
University of California, San Francisco
Other
Eligibility
22 Years to 55 Years · Male only
Enrollment
30 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2003 – 2008
U.S. locations
2
States / cities
San Francisco, California
Source: ClinicalTrials.gov public record
Updated Dec 21, 2008 · Synced Sep 4, 2026, 12:03 AM EDT
Completed No phase listed Observational Accepts healthy volunteers

Role of Hormones in Susceptibility to Seizures in Women With Epilepsy

NCT00044252
View directory record Official record
Conditions
Epilepsy
Interventions
Not listed
Lead sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Eligibility
18 Years to 45 Years · Female only
Enrollment
50 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2002 – 2008
U.S. locations
1
States / cities
Bethesda, Maryland
Source: ClinicalTrials.gov public record
Updated Jul 1, 2017 · Synced Sep 4, 2026, 12:03 AM EDT
Completed Phase 2 Interventional Results available

Neuroactive Steroids and Traumatic Brain Injury (TBI) in OEF/OIF Veterans

NCT01336413
View directory record Official record
Conditions
Brain Injuries, Traumatic
Interventions
Pregnenolone, Placebo
Drug
Lead sponsor
VA Office of Research and Development
Federal
Eligibility
21 Years to 55 Years
Enrollment
53 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2016
U.S. locations
1
States / cities
Durham, North Carolina
Source: ClinicalTrials.gov public record
Updated Jul 11, 2019 · Synced Sep 4, 2026, 12:03 AM EDT