Evaluating fluoxetine for treating PTSD
A Phase 2, Multi-center, Multi-arm, Randomized, Placebo-controlled, Double-blind, Adaptive Platform Study to Evaluate the Safety, Tolerability, and Efficacy of Potential Pharmacotherapeutic Interventions in Active-Duty Service Members and Veterans With PTSD
PHASE2 · Global Coalition for Adaptive Research · NCT05948553
This study is testing if fluoxetine can help people with PTSD feel better compared to a placebo over 12 weeks.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Global Coalition for Adaptive Research (other) |
| Locations | 10 sites (Phoenix, Arizona and 9 other locations) |
| Trial ID | NCT05948553 on ClinicalTrials.gov |
What this trial studies
This Phase 2 randomized, double-blinded, placebo-controlled trial assesses the safety and efficacy of fluoxetine in individuals diagnosed with Post Traumatic Stress Disorder (PTSD). Participants will undergo a 30-day screening period followed by a 12-week treatment phase where they will be randomly assigned to receive either fluoxetine or a placebo. The study utilizes an adaptive platform design, allowing for the comparison of multiple interventions against a common control group. The trial aims to gather data on fluoxetine's effectiveness in alleviating PTSD symptoms.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with PTSD who have not recently been treated with fluoxetine.
Not a fit: Patients who have a recent history of fluoxetine treatment for PTSD may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for patients suffering from PTSD.
How similar studies have performed: Other studies utilizing adaptive platform trial designs have shown promise in evaluating multiple interventions, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Phoenix, Arizona and 9 other locations
- Phoenix VA Healthcare System — Phoenix, Arizona, United States (RECRUITING)
- Homestead Associates in Research, Inc. — Miami, Florida, United States (RECRUITING)
- Advanced Discovery Research — Atlanta, Georgia, United States (RECRUITING)
- Tripler Army Medical Center (TAMC) — Tripler AMC, Hawaii, United States (RECRUITING)
- Cincinnati Veteran's Affairs Medical Center — Fort Thomas, Kentucky, United States (RECRUITING)
- Walter Reed National Military Medical Center (WRNMC) — Bethesda, Maryland, United States (RECRUITING)
- Upstate Clinical Research Associates, LLC — Williamsville, New York, United States (RECRUITING)
- Wilford Hall Ambulatory Surgical Center (WHASC) — San Antonio, Texas, United States (RECRUITING)
- Alexander T. Augusta Military Medical Center (ATAMMC): — Fort Belvoir, Virginia, United States (RECRUITING)
- Madigan Army Medical Center — Joint Base Lewis McChord, Washington, United States (RECRUITING)
Study contacts
- Study coordinator: Please visit the website:
- Phone: ptsdclinicaltrial.org
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Post Traumatic Stress Disorder