7 completed, 3 terminated, 1 active not recruiting, 1 not yet recruiting. 5 Phase 2, 2 Early Phase 1, 2 Phase 3, 2 Phase 4, 1 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 5 | Completed 3, Not yet recruiting 1, Terminated 1 |
| Early Phase 1 | 2 | Completed 2 |
| Phase 3 | 2 | Terminated 2 |
| Phase 4 | 2 | Terminated 1, Withdrawn 1 |
| Phase 1 | 1 | Active not recruiting 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Pregnenolone to Target Concurrent PTSD and Stress Induced Alcohol Use in Veterans: A Dose Finding Study Brexanolone - Alcohol Use Disorder (AUD), Post Traumatic Stress Disorder (PTSD) | Phase 2 | Not yet recruiting | Pharmacotherapies for Alcohol and Substance Use Disorders Alliance | 40 | 2027-01-15 | 2026-09-21 |
| Utility of Brexanolone to Target Stress-induced Alcohol Use Among Men and Women With Posttraumatic Stress Disorder Brexanolone - PTSD, Alcohol Use Disorder | Phase 1 | Active not recruiting | Yale University | 25 | 2023-08-01 | 2025-10-14 |
| An Open Label Pilot Study of IV Brexanolone for the Treatment of Post-Traumatic Stress Disorder Brexanolone Injection [Zulresso] - Post-Traumatic Stress Disorder | Phase 4 | Terminated | Donald Jeffrey Newport | 10 | 2023-06-01 | 2026-05-22 |
| Dynamic Neural Mechanisms of Brexanolone-induced Antidepressant Effects in Postpartum Depression Brexanolone - Postpartum Depression | Completed | University of North Carolina, Chapel Hill | 10 | 2022-08-05 | 2025-01-28 | |
| A Study to Evaluate the Long-term Safety and Tolerability of SAGE-324 in Participants With Essential Tremor SAGE-324 - Essential Tremor | Phase 2 / Phase 3 | Terminated | Sage Therapeutics | 97 | 2022-06-03 | 2025-08-01 |
| Effects of Ketamine on ERP/EEG Measures in Healthy Volunteers Ketamine - Healthy | Early Phase 1 | Completed | ERP Biomarker Qualification Consortium | 33 | 2022-05-26 | 2023-02-21 |
| Effects Zulresso on Postpartum Psychosis Brexanolone - Postpartum Psychosis | Early Phase 1 | Completed | University of North Carolina, Chapel Hill | 10 | 2022-02-23 | 2024-08-26 |
| Study to Evaluate SAGE-324 in Participants With Essential Tremor SAGE-324, SAGE-324 Matched Placebo - Essential Tremor | Phase 2 | Completed | Sage Therapeutics | 146 | 2022-01-05 | 2025-05-16 |
| A Study of Brexanolone for Acute Respiratory Distress Syndrome (ARDS) Due to Coronavirus Disease 2019 (COVID-19) Brexanolone, Placebo - Acute Respiratory Distress Syndrome, COVID-19 | Phase 3 | Terminated | Sage Therapeutics | 29 | 2020-12-18 | 2022-08-19 |
| A Study to Evaluate the Efficacy, Safety, and Tolerability of SAGE-324 in Participants With Essential Tremor SAGE-324, SAGE-324 Placebo - Essential Tremor | Phase 2 | Completed | Sage Therapeutics | 69 | 2020-05-19 | 2024-04-17 |
| A Study to Evaluate Multimodal Neuroimaging Parameters in Women With Postpartum Depression Who Are Receiving ZULRESSO™ (Brexanolone) Brexanolone - Postpartum Depression | Phase 4 | Withdrawn | Sage Therapeutics | 2020-02-01 | 2020-08-18 | |
| Event-Related Potential (ERP) Biomarkers in Subjects With Schizophrenia and Healthy Volunteer Subjects Event-Related Potentials (ERP) and Electroencephalogram (EEG) testing with the COGNISION® System - Schizophrenia | Completed | ERP Biomarker Qualification Consortium | 161 | 2019-10-07 | 2021-02-24 | |
| Evaluate SAGE-547 in Participants With Essential Tremor SAGE-547, Placebo - Essential Tremor | Phase 2 | Completed | Sage Therapeutics | 25 | 2014-09-23 | 2022-06-29 |
| National Pregnancy Registry for Psychiatric Medications Pregnant Women, Psychotropic Drugs | Recruiting | Massachusetts General Hospital | 5000 | 2008-11-01 | 2025-10-24 |
Essential Tremor (4) · Stress Disorders, Post-Traumatic (3) · Alcoholism (2) · Depression, Postpartum (2) · Alcohol Drinking (1) · Attention Deficit Disorder with Hyperactivity (1) · COVID-19 (1) · Respiratory Distress Syndrome (1) · Schizophrenia (1) · Wounds and Injuries (1)
brexanolone (8) · Electroencephalography (1) · Ketamine (1) · Pregnanolone (1)
United States (12)
Marco Cecchi, PhD (2) · Donald J Newport, MD (1) · Lee S Cohen, MD (1) · MacKenzie R Peltier, PhD (1) · MacKenzie R. Peltier, Ph.D. (1) · Robert Lasser, MD, MBA (1) · Samantha Meltzer-Brody, MD, MPH (1) · Susan Girdler, PhD (1)
PMID 25939066, PMID 28810177, PMID 30111186, PMID 33710399, PMID 34352165, PMID 35909254, PMID 36602927, PMID 36716275, PMID 36825887, PMID 37235505, PMID 38488388, PMID 41871269
U54AA027989 (1)