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Common antidepressant fluoxetine put to the test for PTSD relief

NCT ID NCT05948553

Symptom relief Sponsor: Global Coalition for Adaptive Research 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 This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 2 study is testing whether fluoxetine, a common antidepressant, can safely reduce PTSD symptoms in active-duty service members, veterans, and civilians. About 200 participants will receive either fluoxetine or a placebo for up to 12 weeks. The main goal is to see if PTSD severity decreases and to monitor any side effects, including suicidal thoughts.

What this could mean

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

Active substance
fluoxetine (an antidepressant)
What this could lead to
If successful, this could provide a well-tolerated, widely available treatment option to reduce PTSD symptoms.
What could go wrong
This is an early Phase 2 trial with only 200 participants, and the study is currently suspended. Fluoxetine is already used for depression, so its effect on PTSD may be modest or no better than placebo.

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

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2023

Expected to finish

May 2028

An estimate. End dates often move.

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 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: No additional inclusion criteria beyond the inclusion criteria specified in the Master Protocol (NCT05422612). Exclusion Criteria: The following exclusion criteria are in addition to the exclusion criteria specified in the Master Protocol (NCT05422612). 1\. Recent history of treatment for PTSD with fluoxetine at doses of 20 mg daily, for at least 4 weeks. A remote history of treatment with fluoxetine for non-PTSD symptoms will be discussed on a case-by-case basis with the contract research organization (CRO) Medical Monitor.

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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.

Post traumatic stress disorder

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    9 sites. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Advanced Discovery Research

    Atlanta, Georgia, 30318, United States

  • Alexander T. Augusta Military Medical Center (ATAMMC):

    Fort Belvoir, Virginia, 22060-5285, United States

  • Cincinnati Veteran's Affairs Medical Center

    Fort Thomas, Kentucky, 41075, United States

  • Homestead Associates in Research, Inc.

    Miami, Florida, 33032, United States

  • Madigan Army Medical Center

    Joint Base Lewis McChord, Washington, 98433, United States

  • Tripler Army Medical Center (TAMC)

    Tripler AMC, Hawaii, 96859, United States

  • Upstate Clinical Research Associates, LLC

    Williamsville, New York, 14221, United States

  • Walter Reed National Military Medical Center (WRNMC)

    Bethesda, Maryland, 20889-5632, United States

  • Wilford Hall Ambulatory Surgical Center (WHASC)

    San Antonio, Texas, 78236, United States

More trials for these conditions

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