Fluoxetine for PTSD
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: U.S. Army Medical Research and Development Command
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.
Do I need to stop my current medications to join the trial?The trial information does not specify if you need to stop your current medications. However, if you have recently been treated for PTSD with fluoxetine at 20 mg daily for at least 4 weeks, you may be excluded. It's best to discuss your specific situation with the trial coordinators.
What safety data is available for fluoxetine (Prozac) treatment?Fluoxetine, marketed as Prozac, is generally considered safe and well-tolerated. Common side effects at the recommended dose of 20 mg/day are related to the gastrointestinal and nervous systems. Higher doses up to 80 mg/day may increase the likelihood of adverse events. Overdose cases suggest fluoxetine is relatively benign, with many patients remaining asymptomatic or experiencing mild symptoms like sleepiness or sinus tachycardia. It is an inhibitor of cytochrome P450 2D6, which can lead to drug interactions, though most are not clinically significant. There are reports of adverse effects and drug interactions, but these are generally manageable in clinical practice.123610
Is the drug Fluoxetine a promising treatment for PTSD?Yes, Fluoxetine is a promising treatment for PTSD. Studies show that it helps reduce PTSD symptoms more effectively than a placebo, and it also lowers the chance of symptoms coming back.457811
What data supports the idea that Fluoxetine for PTSD is an effective treatment?The available research shows mixed results about the effectiveness of Fluoxetine for PTSD. One study found that veterans with combat-related PTSD who took Fluoxetine showed greater improvement compared to those who took a placebo. In this study, the scores measuring PTSD symptoms improved more in the Fluoxetine group. Another study showed that people taking Fluoxetine had a lower relapse rate (22%) compared to those taking a placebo (50%). However, a different study with a larger group of patients did not find a significant difference between Fluoxetine and placebo. This suggests that while some studies show Fluoxetine can be effective, others do not, indicating that its effectiveness may vary among individuals.45789
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.Treatment Details
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.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Intervention A: Fluoxetine HClExperimental Treatment1 Intervention
Group II: Intervention A PlaceboPlacebo Group1 Intervention
Fluoxetine is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Prozac for:
- Depression
- Anxiety
- Obsessive-compulsive disorder
- Bulimia nervosa
- Panic disorder
🇪🇺 Approved in European Union as Prozac for:
- Major depressive episodes
- Obsessive-compulsive disorder
- Bulimia nervosa
Find a clinic near you
Research locations nearbySelect from list below to view details:
Homestead Associates in Research, Inc.Miami, FL
Upstate Clinical Research Associates, LLCWilliamsville, NY
Advanced Discovery ResearchDecatur, GA
Advanced Discovery ResearchAtlanta, GA
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Who is running the clinical trial?
U.S. Army Medical Research and Development CommandLead Sponsor
PPD DEVELOPMENT, LPIndustry Sponsor
Idorsia Pharmaceuticals Ltd.Industry Sponsor
CitelineCollaborator
PPDIndustry Sponsor
Berry ConsultantsCollaborator
Cambridge Cognition LtdIndustry Sponsor
References
Adverse effects and drug interactions associated with fluoxetine therapy. [2019]Fluoxetine, an inhibitor of serotonin reuptake, was released by the Food and Drug Administration in 1988 and was among the most prescribed drugs for that year. Although fluoxetine has been promoted as a safe antidepressant, a recent literature search revealed a number of case reports of adverse effects and drug interactions attributed to its use. This review familiarizes healthcare professionals with some of the currently known interactions and adverse effects and suggests ways of avoiding such events in clinical practice.
The effects of fluoxetine in the overdose patient. [2019]Fluoxetine (Prozac) is a new antidepressant, first marketed in the United States in January 1988. Only limited toxicologic information during a fluoxetine overdose is available. The goal of this prospective multi-center study was to develop a toxicity profile of initial signs and symptoms observed in fluoxetine overdose. A standardized data collection form was used on all patients ingesting fluoxetine as reported to four poison centers. Information obtained included age, dose, co-ingested drugs, presenting symptoms, vital signs, EKG abnormalities and lab values. Of the 127 cases of acute fluoxetine overdose collected, 106 cases met the criteria of the study. Of these, 69/106 ingested other drugs, including ethanol and 37/106 ingested fluoxetine alone. Of the latter group, the amounts ingested ranged from 20 to 1500 mg. It was observed that 48.6% (18/37) remained asymptomatic, 16.2% (7/37) were sleepy, 24.3% (9/37) had a sinus tachycardia (of 100 beats per minute or greater), and 8.1% (3/37) had a diastolic pressure over 100 mm Hg. Data collection is ongoing. Based upon our initial experience, fluoxetine in overdose appears to be relatively benign.
Fluoxetine ingestion: a one year retrospective study. [2022]Fluoxetine (PROZAC) is a recently marketed straight chain antidepressant unrelated to the cyclic anti-depressants. There is only limited information on fluoxetine and a single case report on overdose (benign outcome) in the literature. In response to this we performed a 1y retrospective chart review at 2 AAPCC certified poison centers. Forty-four exposures to fluoxetine were reviewed from 1988; 31 cases were treated in a HCF, 2 cases were followed at home by phone and 11 cases were lost to follow up. Thirteen cases with follow up (FU) reported no coingestants; 3 cases reported increased anxiety without cardiovascular (CV) changes, 2 cases presented confused with out CV changes, and 8 cases were asymptomatic. Eight cases with FU had ETOH and/or benzodiazepines as a coingestant and experienced only a decreased level of consciousness that could be explained by the coingestant. Five cases remained asymptomatic with reported coingestants of APAP #3, lorazepam, haloperidol, molindone, alprazolam, propranolol, phenobarbital (level 18.2). Four cases were excluded from the evaluation due to the coingestants involved. No seizures were recorded in this series. Three possible drug reactions occurred; 2 cases had reactions with tranylcypromine (PARNATE), and 1 case with a diagnosis of septicemia had a severe hyperthermic reaction with therapeutic coingestants of mephytoin, verapamil, digoxin and indocin. We believe overdose with fluoxetine present minimal risk of serious cardiovascular or neurological complications.
Open prospective trial of fluoxetine for posttraumatic stress disorder. [2013]Twenty-seven patients with combat-related posttraumatic stress disorder (PTSD) entered an open, prospective, 10-week trial of fluoxetine, beginning with 20 mg/day and increasing to 80 mg/day until response was optimal or side effects prohibited dose increase. Nineteen patients completed 3 or more weeks and were included in the data analysis. Total Clinician-Administered PTSD Scale scores decreased from a mean of 64.5 at baseline to 42.7 at endpoint (F = 7.17, p
Tolerability of fluoxetine in posttraumatic stress disorder. [2022]In response to earlier reports that raised concerns about the tolerability of fluoxetine in the treatment of posttraumatic stress disorder (PTSD), this study was conducted to systematically delineate treatment-emergent symptoms (TES) associated with fluoxetine treatment of PTSD.
Safety and side effect profile of fluoxetine. [2022]Fluoxetine was the first selective serotonin re-uptake inhibitor to be widely available for treatment of depression and numerous other neuropsychiatric disorders. Its attributes have been described in numerous scientific papers, and it has been the subject of a considerable volume of lay press. Fluoxetine is generally safe and well-tolerated. Common adverse events reported with the recommended dose of 20 mg/day are referable to the gastrointestinal system and the nervous system. The approved dose range is up to 80 mg/day, and when higher doses are used, adverse events are more common. The long half-life of fluoxetine and its active metabolite essentially preclude a withdrawal phenomenon. It is an inhibitor of cytochrome P450 (CYP) 2D6 and other CYP enzymes, which increases the potential for drug interactions. However, most of these are not clinically important. The purpose of this review is to provide an overview of some of the most important information related to safety and side effects of this drug.
Maintenance therapy with fluoxetine in posttraumatic stress disorder: a placebo-controlled discontinuation study. [2019]The effect of fluoxetine (FLU) in posttraumatic stress disorder was studied in a one-year trial. Subjects received open-label treatment for 6 months, followed by double-blind randomized treatment with FLU or placebo (PBO) for 6 months. Rates of relapse were compared using the Clinical Global Impressions of Improvement. One hundred twenty-three subjects entered open-label treatment, of whom 114 returned at least once. Sixty-two subjects were randomized to receive FLU or PBO, of whom 57 returned at least once and were analyzed. The dose of FLU ranged from 10 to 60 mg/d; at randomization, mean doses were 48.6 and 42.1 mg for FLU and PBO groups. Rates of relapse were 22% for FLU versus 50% for PBO (P = 0.02), and time to relapse on FLU was longer than for PBO (P = 0.02, log-rank statistic). The odds ratio for relapse on PBO relative to FLU was 3.50. No significant differences were found on other measures. Fluoxetine was well tolerated during double-blind treatment.
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]The efficacy and safety of fluoxetine (20-80 mg) was compared with placebo in 144 veterans [36.2 years], diagnosed with combat-related post-traumatic stress disorder (PTSD) selected from a 12-week acute and 24-week relapse prevention PTSD trial. In the acute phase, improvements were greater with fluoxetine than placebo in the disease-specific outcome measures: Treatment Outcome PTSD (TOP-8) total scores (SE):-9.05 (0.90) and -5.20 (1.23), p = 0.001; Clinician Administered PTSD Scale (CAPS) total scores:-31.12 (2.72) and -16.07 (4.24), p
Failed efficacy of fluoxetine in the treatment of posttraumatic stress disorder: results of a fixed-dose, placebo-controlled study. [2013]A multicenter, double-blind, 12-week, placebo-controlled trial of 411 randomized patients, predominantly women diagnosed with posttraumatic stress disorder, failed to show a difference between either dose of fluoxetine treatment and placebo. The mean changes from baseline (SD) measured by the Clinician-Administered PTSD Scale scores were -42.9 (23.1), -42.8 (27.9), and -36.6 (25.7) in the 20-mg fluoxetine, 40-mg fluoxetine, and placebo arms, respectively. Placebo response rate was substantially higher in this study than in a previously published fluoxetine trial of posttraumatic stress disorder.
The fetal safety of fluoxetine: a systematic review and meta-analysis. [2022]Fluoxetine is the selective serotonin reuptake inhibitor (SSRI) with the longest clinical use. Published reports regarding its fetal safety are contradictory. We aimed to establish the fetal safety of the drug.
Patient and Clinical Factors Associated With Response to Medications for Posttraumatic Stress Disorder. [2022]Objective: Fluoxetine, paroxetine, sertraline, topiramate, and venlafaxine have previously shown efficacy for posttraumatic stress disorder (PTSD) in randomized clinical trials. Two prior studies using Department of Veterans Affairs (VA) medical records data show these medications are also effective in routine practice. Using an expanded retrospective cohort, we assessed the possibility of differential patterns of response based on patient and clinical factors.