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

NCT05254405 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-05-22

No results posted yet for this study

Summary

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 24 hours at up to 60 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 self-assessment Montgomery-Asberg Depression Rating Scale (MADRS-S) total score and Sheehan Disability Scale scores

Conditions

  • Post-Traumatic Stress Disorder

Interventions

DRUG

Brexanolone Injection [Zulresso]

Continuous infusion of brexanolone over 60 hours titrated to a maximal dose of 90 mcg/kg/hr.

Sponsors & Collaborators

  • Sage Therapeutics

    collaborator INDUSTRY

  • Donald Jeffrey Newport

    lead OTHER

Principal Investigators

  • Donald J Newport, MD · University of Texas at Austin/ Dell Medical School

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2025-12-30
Completion
2025-12-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05254405 on ClinicalTrials.gov