Fluoxetine for PTSD

Recruiting in Palo Alto (17 mi)

+7 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Global Coalition for Adaptive Research

Must not be taking: Fluoxetine

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{1 2 4 5 11}

Research Team

Eligibility Criteria

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

No additional inclusion criteria beyond the inclusion criteria specified in the Master Protocol (NCT05422612)

Exclusion Criteria

I have taken fluoxetine in the past for reasons other than PTSD.

I have been treated for PTSD with fluoxetine 20 mg daily for at least 4 weeks.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (in-person)

Treatment

Participants receive fluoxetine or placebo for the treatment of PTSD

12 weeks

Regular visits (frequency not specified)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• Fluoxetine (Selective Serotonin Reuptake Inhibitor)

Trial Overview The study is testing Fluoxetine Hydrochloride's safety and effectiveness in treating PTSD compared to a placebo. It's a Phase 2 trial where participants are randomly assigned to either the medication or placebo without knowing which one they're getting.

Participant Groups

Group I: Intervention A: Fluoxetine HCl Experimental Treatment 1 Intervention

Group II: Intervention A Placebo Placebo Group 1 Intervention

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Homestead Associates in Research, Inc. Miami, FL

Upstate Clinical Research Associates, LLC Williamsville, NY

Advanced Discovery Research Decatur, GA

Cincinnati Veteran's Affairs Medical Center Fort Thomas, KY

More Trial Locations

Who Is Running the Clinical Trial?

Global Coalition for Adaptive Research

Lead Sponsor

Trials

7

Patients Recruited

22,600+

PPD DEVELOPMENT, LP

Industry Sponsor

Trials

167

Patients Recruited

38,000+

Citeline

Industry Sponsor

Trials

5

Patients Recruited

1,600+

Idorsia Pharmaceuticals Ltd.

Industry Sponsor

Trials

124

Patients Recruited

36,400+

Citeline

Collaborator

Trials

5

Patients Recruited

1,600+

U.S. Army Medical Research and Development Command

Collaborator

Trials

296

Patients Recruited

249,000+

PPD

Industry Sponsor

Trials

162

Patients Recruited

36,600+

Berry Consultants

Collaborator

Trials

16

Patients Recruited

58,200+

Cambridge Cognition Ltd

Industry Sponsor

Trials

17

Patients Recruited

4,700+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fluoxetine in the acute treatment and relapse prevention of combat-related post-traumatic stress disorder: Analysis of the veteran group of a placebo-controlled, randomized clinical trial. Martenyi, F., Soldatenkova, V.[2014]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maintenance therapy with fluoxetine in posttraumatic stress disorder: a placebo-controlled discontinuation study. Davidson, JR., Connor, KM., Hertzberg, MA., et al.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Failed efficacy of fluoxetine in the treatment of posttraumatic stress disorder: results of a fixed-dose, placebo-controlled study. Martenyi, F., Brown, EB., Caldwell, CD.[2013]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Open prospective trial of fluoxetine for posttraumatic stress disorder. Nagy, LM., Morgan, CA., Southwick, SM., et al.[2013]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tolerability of fluoxetine in posttraumatic stress disorder. Barnett, SD., Tharwani, HM., Hertzberg, MA., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fluoxetine ingestion: a one year retrospective study. Spiller, HA., Morse, S., Muir, C.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The fetal safety of fluoxetine: a systematic review and meta-analysis. Riggin, L., Frankel, Z., Moretti, M., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of fluoxetine in the overdose patient. Borys, DJ., Setzer, SC., Ling, LJ., et al.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and side effect profile of fluoxetine. Wernicke, JF.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse effects and drug interactions associated with fluoxetine therapy. Levinson, ML., Lipsy, RJ., Fuller, DK.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient and Clinical Factors Associated With Response to Medications for Posttraumatic Stress Disorder. Shiner, BR., Gui, J., Rozema, L., et al.[2022]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Fluoxetine in the acute treatment and relapse prevention of combat-related post-traumatic stress disorder: Analysis of the veteran group of a placebo-controlled, randomized clinical trial. [2014]

2. United States pubmed.ncbi.nlm.nih.gov

Maintenance therapy with fluoxetine in posttraumatic stress disorder: a placebo-controlled discontinuation study. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Failed efficacy of fluoxetine in the treatment of posttraumatic stress disorder: results of a fixed-dose, placebo-controlled study. [2013]

4. United States pubmed.ncbi.nlm.nih.gov

Open prospective trial of fluoxetine for posttraumatic stress disorder. [2013]

5. England pubmed.ncbi.nlm.nih.gov

Tolerability of fluoxetine in posttraumatic stress disorder. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Fluoxetine ingestion: a one year retrospective study. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

The fetal safety of fluoxetine: a systematic review and meta-analysis. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

The effects of fluoxetine in the overdose patient. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Safety and side effect profile of fluoxetine. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Adverse effects and drug interactions associated with fluoxetine therapy. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Patient and Clinical Factors Associated With Response to Medications for Posttraumatic Stress Disorder. [2022]