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Brexanolone for Post-Traumatic Stress Disorder
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 4 trial • 52 Patients • NCT05059600Trial Design
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- I have been diagnosed with PTSD from a non-military trauma.I have been diagnosed with PTSD from a civilian trauma.I am not starting any new mental health medications within 2 weeks of screening.I have a history of seizures.I am a woman aged 18-50 and have not gone through menopause.I am in good health with normal physical exams, heart tests, and lab results.I have taken specific medications before.I am willing to wait to start any new medications until after the initial study period.I have kidney failure needing dialysis, severe liver failure, or low blood hemoglobin.I am allergic to certain hormone medications.
- Group 1: Open-Label Infusion of Brexanolone
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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