Fluoxetine for PTSD
What You Need to Know Before You Apply
What is the purpose of this trial?
This is a Phase 2 randomized, double-blinded, placebo-controlled study that will evaluate multiple potential pharmacotherapeutic interventions for PTSD utilizing an adaptive platform trial design.Intervention A - Fluoxetine will assess the safety and efficacy of fluoxetine in participants with PTSD.Please see NCT05422612 for information on the S-21-02 Master Protocol.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you have been recently treated for PTSD with fluoxetine at 20 mg daily for at least 4 weeks, you may not be eligible to participate.
Is fluoxetine generally safe for humans?
Fluoxetine, also known as Prozac, is generally considered safe and well-tolerated for humans. Common side effects include issues with the stomach and nervous system, and it can interact with other drugs, but most interactions are not serious. In cases of overdose, it appears to be relatively benign with minimal risk of serious complications.12345
How does the drug fluoxetine differ from other treatments for PTSD?
Fluoxetine, commonly known as Prozac, is unique for PTSD treatment as it has been shown to significantly reduce symptoms in combat-related PTSD and prevent relapse better than a placebo. It is a selective serotonin reuptake inhibitor (SSRI), which works by increasing serotonin levels in the brain, a different mechanism compared to other PTSD medications like topiramate or venlafaxine.678910
What data supports the effectiveness of the drug fluoxetine for treating PTSD?
Research shows that fluoxetine can be effective for PTSD, as one study found it led to greater improvements in PTSD symptoms compared to a placebo, and another study showed lower relapse rates with fluoxetine. However, another study did not find a significant difference between fluoxetine and placebo, indicating mixed results.6791011
Are You a Good Fit for This Trial?
This trial is for individuals with PTSD who haven't been treated with fluoxetine (20 mg daily) for at least 4 weeks recently. If they've used fluoxetine before for other reasons, they might still qualify but will need to discuss this with the study's medical monitor.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive fluoxetine or placebo for the treatment of PTSD
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Fluoxetine
Fluoxetine is already approved in United States, European Union for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Global Coalition for Adaptive Research
Lead Sponsor
PPD DEVELOPMENT, LP
Industry Sponsor
David Simmons
PPD DEVELOPMENT, LP
Chief Executive Officer since 2012
BSc in Applied Science from Georgia Institute of Technology
Martina Flammer
PPD DEVELOPMENT, LP
Chief Medical Officer since 2024
MD
Citeline
Industry Sponsor
PPD Development, LP
Industry Sponsor
Idorsia Pharmaceuticals Ltd.
Industry Sponsor
Antonio Olivieri
Idorsia Pharmaceuticals Ltd.
Chief Medical Officer since 2024
Not specified
André C. Muller
Idorsia Pharmaceuticals Ltd.
Chief Executive Officer
Not specified
Citeline
Collaborator
U.S. Army Medical Research and Development Command
Collaborator
PPD
Industry Sponsor
Dr. Austin Smith
PPD
Chief Medical Officer since 2020
Doctor of Medicine from the Royal College of Surgeons in Ireland
David Simmons
PPD
Chief Executive Officer since 2012
Bachelor’s degree in Applied Mathematics and Industrial Management from Carnegie Mellon University
Berry Consultants
Collaborator
Cambridge Cognition Ltd
Industry Sponsor