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TerminatedNCT05254405

An Open Label Study of IV Brexanolone for PTSD

This study has public registry information. It focuses on PTSD and currently lists study information in the United States.

PTSDDrugFrom 18 Years to 50 Years
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Study ID: NCT05254405. We help you review the study, but cannot decide medical eligibility.
In plain English

Key information made simple

What is this study testing?

This study is testing whether IV Brexanolone may be useful for adults experiencing ptsd.

What would participation involve?

Participants may receive IV Brexanolone, complete questionnaires or follow-up assessments, attend study visits with the research team. The registry lists locations in the United States.

Who is it mainly for?

This study appears to be mainly for adults with ptsd.

What should you check before joining?

Ask about the dose, safety monitoring, and possible side effects, whether there is a comparison group, how many visits or travel steps are needed, the exact eligibility criteria.

What to expect

Your next step

The official record does not clearly describe the visit format, so the practical details are best checked directly in the source. Participation appears to involve study activities and follow-up chosen by the research team. The main fit and exclusions are best confirmed in the eligibility section of the official record. The phase details are not clearly stated here.

Before joining

Questions to ask before joining

Study clarity

Things to check before joining

Study start dateNot clearly listed
Recruitment status
Terminated
Estimated enrollment
10
Sponsor
Donald Jeffrey Newport
Sponsor type
Unknown or unclear
Study type
Drug
Intervention type
Medication / drug
Study phase
PHASE4Usually happens after approval, to monitor real-world use, safety, and longer-term outcomes.
Locations
United States
Age range
From 18 Years to 50 Years
Official registry ID
NCT05254405
Official title
An Open Label Pilot Study of IV Brexanolone for the Treatment of Post-Traumatic Stress Disorder
Official source
Official registry link

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Study ID: NCT05254405. We help you review the study, but cannot decide medical eligibility.
In practice

For you

Taking part may give access to a new approach being evaluated.

It requires regular follow-up, often through questionnaires or interviews.

Important

Not medical advice

Information from public sources. Are you the study sponsor? Contact us to update this page: hi@hopestage.com

FAQ

Questions about this study

What is this study trying to understand?

Based on the public registry summary, this study is trying to understand: Open-label study of brexanolone infusion for the treatment of posttraumatic stress disorder in 20 adult women with PTSD. Primary Objective: To determine if brexanolone injection infused intravenously for 24 hours at up to 60 μg/kg/h reduces PTSD symptom severity in a group of. The study team can confirm the exact objective and what it means for you.

Does this study involve a medication?

This appears to be a medication / drug study involving Brexanolone Injection [Zulresso]. The listed phase is PHASE4. Ask the study team what that means in practice for safety, monitoring, and criteria.

Who might this study be for?

This study may concern people with ptsd; age range: From 18 Years to 50 Years. The criteria appear fairly specific, but you should not assume you are eligible. The study team must confirm diagnosis, age, exclusions, available locations, and next steps.

What would I likely need to do?

You may need to take a study treatment and have regular medical follow-up. The listed study locations suggest that at least part of participation may involve a physical site. Ask whether some steps can be done remotely.

Will I need to change, stop, or stabilize my current treatment?

The public registry appears to mention rules about current treatment, stability, stopping treatment, or dose changes. Do not change your treatment for a study without medical guidance. Ask the study team and your clinician what is required, what is not allowed, and how safety is monitored.

Will I need to travel or attend in-person visits?

The listed study locations suggest that at least part of participation may involve a physical site. Ask which sites are open, how many visits are expected, whether any steps can be done remotely, and whether travel costs or compensation are listed.

Who is behind this study?

This study is sponsored by Donald Jeffrey Newport, which appears to be unknown or unclear. If available, it can be useful to check the sponsor website, collaborators, investigator affiliation, and the official registry before deciding. HopeStage does not judge the quality of a sponsor or researcher, but helps you identify what to verify.

Can I still join this study?

The registry indicates that this study is not currently recruiting. Check the official registry for the reason and latest status. The registry lists an estimated enrollment of 10 participants.

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