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Study details
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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

About this study

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.

Based on ClinicalTrials.gov records.

What participants do

  • 1.Receive Brexanolone Injection [Zulresso]
PhasePhase 4
DrugBrexanolone Injection [Zulresso]
Routeinjection
Primary goalChange in PTSD Symptom Severity: PTSD Checklist for DSM-5 (PCL-5)

Participation effort

Estimated from trial records. Details can vary by site.

Time + visits
Low11%
Logistics
Moderate50%

Logistics difficulty varies by site location and availability.

Trial highlights

Treatment details

Auto-extracted from trial records to preview treatments and outcomes.

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