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PTSD drug safety study halted early: what we know

NCT ID NCT04468360

Knowledge-focused Sponsor: Boston University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This small Phase 2 study aimed to test the safety and dosing of an intravenous drug called allopregnanolone (also known as brexanolone) in 11 people with chronic PTSD. The trial was terminated before completion, so results are limited. The main goal was to monitor sedation levels and vital signs, not to measure whether the drug reduces PTSD symptoms.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
allopregnanolone (brexanolone)
What this could lead to
If successful, this could help determine safe dosing for future studies testing whether allopregnanolone can improve PTSD treatment.
What could go wrong
This was a very small, early-stage safety study that was terminated. It does not test whether the drug actually helps PTSD symptoms.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

11 people

The number who actually took part.

Started

Mar 2022

Finished

Apr 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Chronic Posttraumatic Stress Disorder * Generally healthy and not on any prohibited medications (that could affect study outcomes) * Willing to abstain from alcohol for 2 weeks and from nicotine, marijuana or illicit drugs for 4 weeks before experimental procedures and throughout the study * Females: must have a menstrual cycle and not be on hormonal birth control (with a few exceptions; see below) * If gender non-conforming: must not be on hormone therapy Exclusion Criteria: * Bipolar I disorder, schizophreniform disorder, or clinically significant psychotic symptoms apart from the presence of trauma-related sensory hallucinations or negative beliefs * Moderate or severe substance use disorder within three months of screening * Sleep Apnea * History of a suicide attempt within 1 year of enrolling * Imminent risk to self or others or requiring clinical intervention to maintain safety * Unstable medical condition or condition that may affect outcomes * Moderate or severe traumatic brain injury (TBI) (mild TBI acceptable; moderate TBI allowed for PK study) * Using any medications or substances (per self-report or toxicology testing) that may increase the risk for IV Allo side effects or affect the experimental results. * Unable to tolerate IV placement or blood drawing by needle stick * Wear hearing aids or fail hearing test (not applicable to PK study) * Females: pregnant, breastfeeding, or if of childbearing potential, unwilling to use two forms of effective birth control \[except for hormonal contraceptives, unless intrauterine device (IUD) or a device like NuvaRing\] for one week before and one month after study drug administration

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Conditions

The condition(s) this trial relates to.

post-traumatic stress disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pharmacokinetic study Post-traumatic stress disorder

Contacts and locations

Locations

  • Boston University Chobanian & Avedisian School of Medicine

    Boston, Massachusetts, 02118, United States

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Other studies related to the condition(s) this trial covers.