← Back to Search

Corticosteroid

Brexanolone for Post-Traumatic Stress Disorder

Phase 4
Recruiting
Led By Donald J Newport, MD
Research Sponsored by Donald Jeffrey Newport
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject has a current diagnosis of PTSD associated with civilian trauma according to DSM-5 and confirmed by MINI at the screening visit
Subject is a premenopausal female between 18 and 50 years of age, inclusive
Must not have
History of seizure disorder
Previous treatment with specified medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study endpoint (week 12 / day 90)
Awards & highlights

Summary

This trial will test if brexanolone injection can reduce PTSD symptoms in 20 adult women. Researchers will measure safety, depression levels, and functional capacity.

Who is the study for?
This trial is for premenopausal women aged 18-50 with PTSD from civilian trauma, fluent in the test language, and in good health. Participants must not be pregnant or breastfeeding, have a stable psychotropic medication dose if any, and agree to use effective birth control during the study.Check my eligibility
What is being tested?
The study tests Brexanolone Injection [Zulresso], given intravenously over 60 hours to see if it reduces PTSD symptoms severity based on PCL-5 scores and improves sleepiness and depression scales without causing significant side effects.See study design
What are the potential side effects?
Potential side effects include changes in vital signs (like blood pressure), sleepiness as measured by the Stanford Sleepiness Scale, increased risk of suicidal thoughts assessed by Columbia Suicide Severity Rating Scale, and other adverse events that will be monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with PTSD from a civilian trauma.
Select...
I am a woman aged 18-50 and have not gone through menopause.
Select...
I am in good health with normal physical exams, heart tests, and lab results.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a history of seizures.
Select...
I have taken specific medications before.
Select...
I have kidney failure needing dialysis, severe liver failure, or low blood hemoglobin.
Select...
I am allergic to certain hormone medications.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study endpoint (week 12 / day 90)
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study endpoint (week 12 / day 90) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in PTSD Symptom Severity: PTSD Checklist for DSM-5 (PCL-5)
Secondary outcome measures
Change in Depressive Symptoms: Montgomery-Asberg Depression Rating Scale (MADRS)
Change in Functional Capacity: Sheehan Disability Scale (SDS)
Change in PTSD Subscale Symptoms: PTSD Checklist for DSM-5 (PCL-5)
Other outcome measures
Pulse Oximetry
Sedation: Stanford Sleepiness Scale (SSS)
Suicidal Ideation: Columbia Suicide Severity Rating Scale (C-SSRS)

Side effects data

From 2022 Phase 4 trial • 52 Patients • NCT05059600
12%
Fatigue
10%
Headache
7%
Somnolence
7%
Infusion site pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
ZULRESSO®

Trial Design

1Treatment groups
Experimental Treatment
Group I: Open-Label Infusion of BrexanoloneExperimental Treatment1 Intervention
This is a single arm pilot study of open label brexanolone delivered intravenously over a continuous 60-hour period. Infusions will be administered in a certified healthcare setting in accordance with the Zulresso™ dosing, administration and safety guidelines.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Brexanolone, a positive allosteric modulator of GABA-A receptors, enhances the inhibitory effects of GABA, the primary inhibitory neurotransmitter in the brain, which can help reduce the hyperarousal and anxiety symptoms associated with PTSD. This mechanism is crucial for PTSD patients as it directly targets the heightened state of arousal and stress response. Other common treatments include SSRIs and SNRIs, which work by increasing the levels of serotonin and norepinephrine in the brain, respectively. These neurotransmitters are involved in mood regulation and can help alleviate the depressive and anxiety symptoms of PTSD. Understanding these mechanisms is important for tailoring treatment to individual patient needs and improving overall symptom management.

Find a Location

Who is running the clinical trial?

Donald Jeffrey NewportLead Sponsor
Sage TherapeuticsIndustry Sponsor
49 Previous Clinical Trials
11,730 Total Patients Enrolled
Donald J Newport, MDPrincipal InvestigatorUniversity of Texas at Austin/ Dell Medical School

Media Library

Brexanolone Injection [Zulresso] (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT05254405 — Phase 4
Post-Traumatic Stress Disorder Research Study Groups: Open-Label Infusion of Brexanolone
Post-Traumatic Stress Disorder Clinical Trial 2023: Brexanolone Injection [Zulresso] Highlights & Side Effects. Trial Name: NCT05254405 — Phase 4
Brexanolone Injection [Zulresso] (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05254405 — Phase 4
~11 spots leftby Dec 2025