Skip to content
Study details
Enrolling now

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

Donald Jeffrey Newport
NCT IDNCT05254405ClinicalTrials.gov data as of Apr 2026
Phase

Phase 4

Target enrollment

20

Study length

about 2.8 years

Ages

18–50

Sex

Female only

Locations

1 site in TX

What this study is about

Researchers are testing a treatment called brexanolone, given as an injection into a vein, to see if it helps reduce symptoms of PTSD in adult women. The trial will last 1004 days and involve approximately 20 women with PTSD who are not veterans.

Simplified from trial records by PatientMatch.

What you may be asked to do

  • 1.Receive Brexanolone Injection [Zulresso]

Participation Burden

What's physically and logistically required of participants.

Logistics & Travel
In-person visits

Requires travel to a study site

Physical Intervention
Injection / IV

How treatment is administered

Treatment Assignment
All receive treatment

Everyone gets the investigational treatment.

Extracted study details

Pulled from the trial record to show what is being tested and what the study is measuring.

Drug classes

brexanolone

Drug routes

injection

Endpoints

Primary: Change in PTSD Symptom Severity: PTSD Checklist for DSM-5 (PCL-5)

Secondary: Change in Depressive Symptoms: Montgomery-Asberg Depression Rating Scale (MADRS), Change in PTSD Subscale Symptoms: PTSD Checklist for DSM-5 (PCL-5)

Body systems

Psychiatry / Mental Health