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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study endpoint (week 12 / day 90)

Awards & highlights

Study 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

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I have been diagnosed with PTSD from a civilian trauma.

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I am a woman aged 18-50 and have not gone through menopause.

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I am in good health with normal physical exams, heart tests, and lab results.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study endpoint (week 12 / day 90)

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

Somnolence

Infusion site pain

100%

80%

60%

40%

20%

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.

0 / 3Eligibility criteria met

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Who is running the clinical trial?

Donald Jeffrey NewportLead Sponsor

Sage TherapeuticsIndustry Sponsor

49 Previous Clinical Trials

11,741 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research affording the opportunity for individuals aged 40 and above to participate?

"This medical trial has a strict age limit of 18-50 years for enrolment. There are 40 studies available that cater to younger patients, while 324 trials exist for those above the senior citizen threshold."

Answered by AI

Could you assess the risks of Open-Label Infusion of Brexanolone for participants?

"Considering the Phase 4 trial status of Open-Label Infusion of Brexanolone, our team at Power assigned it a 3 out of 3 for safety. This implies that this treatment is approved and has been tested multiple times with favourable results."

Answered by AI

Which cohort of participants would be best suited for this research?

"The criteria for patient selection in this clinical trial requires that applicants have PTSD and are between 18 to 50 years of age. Currently, the research team is looking for up to 20 individuals who fit these qualifications."

Answered by AI

How many test subjects are partaking in this experiment?

"Affirmative. The information posted on clinicaltrials.gov demonstrates that this medical trial is actively recruiting volunteers. It was first announced on June 1, 2023 and its listings were last updated four days later. Twenty participants need to be recruited from a single location for the experiment to commence."

Answered by AI

Are there any unfilled vacancies for participants in this research?

"The clinical trial is currently open to participants, as evidenced by the information hosted on clinicaltrials.gov. This medical study was initially posted on June 1st 2023 and edited for the last time four days later."

Answered by AI