You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: May 28, 2024

~ Buy the ZULRESSO (brexanolone) Drug Profile, 2024 PDF Report in the Report Store ~

CLINICAL TRIALS PROFILE FOR ZULRESSO


✉ Email this page to a colleague

« Back to Dashboard


All Clinical Trials for Zulresso

Trial ID Title Status Sponsor Phase Start Date Summary
NCT04273191 ↗ A Study to Evaluate Multimodal Neuroimaging Parameters in Women With Postpartum Depression Who Are Receiving ZULRESSO™ (Brexanolone) Withdrawn Sage Therapeutics Phase 4 2020-02-01 In this Phase 4 study, women who have been prescribed commercial ZULRESSO™ (brexanolone) by a physician as standard of care for postpartum depression (PPD) and who are planning to receive the infusion per United States Prescribing Information (USPI) at a Risk Evaluation and Mitigation Strategy (REMS)-certified healthcare center are being asked to participate to collect data on multimodal neuroimaging parameters in order to evaluate the relationship between changes in depressive symptoms and changes in neuroimaging parameters.
NCT04537806 ↗ A Study of Brexanolone for Acute Respiratory Distress Syndrome Due to COVID-19 Terminated Sage Therapeutics Phase 3 2020-12-18 The purpose of this study is to evaluate the efficacy and safety of brexanolone in participants on ventilator support for acute respiratory distress syndrome (ARDS) due to COVID-19.
NCT05059600 ↗ A Study To Assess The Safe-Use Conditions For Administration of ZULRESSO® in a Home Setting Not yet recruiting Sage Therapeutics Phase 4 2021-11-01 The primary purpose of this study is to evaluate whether the safe-use conditions for administration of brexanolone (ZULRESSO®) can be implemented in a home setting.
NCT05223829 ↗ Utility of Brexanolone to Target Stress-induced Alcohol Use Among Men and Women With Posttraumatic Stress Disorder Not yet recruiting National Institute on Alcohol Abuse and Alcoholism (NIAAA) Phase 1 2022-03-01 For this protocol, the investigators plan to collect pilot data to: 1. establish the feasibility and safety of administering brexanolone to individuals with concurrent Posttraumatic Stress Disorder (PTSD) and Alcohol Use Disorder (AUD).
NCT05223829 ↗ Utility of Brexanolone to Target Stress-induced Alcohol Use Among Men and Women With Posttraumatic Stress Disorder Not yet recruiting Sage Therapeutics Phase 1 2022-03-01 For this protocol, the investigators plan to collect pilot data to: 1. establish the feasibility and safety of administering brexanolone to individuals with concurrent Posttraumatic Stress Disorder (PTSD) and Alcohol Use Disorder (AUD).
NCT05223829 ↗ Utility of Brexanolone to Target Stress-induced Alcohol Use Among Men and Women With Posttraumatic Stress Disorder Not yet recruiting Yale University Phase 1 2022-03-01 For this protocol, the investigators plan to collect pilot data to: 1. establish the feasibility and safety of administering brexanolone to individuals with concurrent Posttraumatic Stress Disorder (PTSD) and Alcohol Use Disorder (AUD).
NCT05254405 ↗ An Open Label Pilot Study of IV Brexanolone for the Treatment of Post-Traumatic Stress Disorder Not yet recruiting Sage Therapeutics Phase 4 2022-03-01 Open-label study of brexanolone infusion for the treatment of posttraumatic stress disorder in 20 adult women with PTSD. Primary Objective: To determine if brexanolone injection infused intravenously for 60 hours at up to 90 μg/kg/h reduces PTSD symptom severity in a group of non-veteran adult female subjects diagnosed with PTSD as assessed by the change from baseline in the PTSD Checklist for DSM-5 (PCL-5) total score and rate of remission at 12-weeks post infusion. Secondary Objectives - To evaluate the safety and tolerability profiles of brexanolone in this PTSD patient population as assessed by the incidence of adverse events (AEs), vital sign measurement, the Stanford Sleepiness Scale (SSS) and the Columbia Suicide Severity Rating Scale (C-SSRS). - To determine the effects of brexanolone in reducing depressive symptoms and improving functional capacity in PTSD patients as assessed by change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score and Sheehan Disability Scale scores
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Zulresso

Condition Name

Condition Name for Zulresso
Intervention Trials
Postpartum Depression 2
PTSD 1
Acute Respiratory Distress Syndrome 1
Alcohol Use Disorder 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for Zulresso
Intervention Trials
Stress Disorders, Post-Traumatic 2
Depressive Disorder 2
Depression, Postpartum 2
Depression 2
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for Zulresso

Trials by Country

Trials by Country for Zulresso
Location Trials
United States 12
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for Zulresso
Location Trials
North Carolina 2
California 2
Connecticut 1
Washington 1
Virginia 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for Zulresso

Clinical Trial Phase

Clinical Trial Phase for Zulresso
Clinical Trial Phase Trials
Phase 4 4
Phase 3 1
Phase 1 1
[disabled in preview] 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for Zulresso
Clinical Trial Phase Trials
Not yet recruiting 4
Recruiting 1
Terminated 1
[disabled in preview] 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for Zulresso

Sponsor Name

Sponsor Name for Zulresso
Sponsor Trials
Sage Therapeutics 6
Yale University 1
Donald Jeffrey Newport 1
[disabled in preview] 3
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for Zulresso
Sponsor Trials
Industry 6
Other 4
NIH 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.