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Selective Serotonin Reuptake Inhibitor
Fluoxetine for PTSD
Phase 2
Recruiting
Research Sponsored by U.S. Army Medical Research and Development Command
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Study Summary
This trial will evaluate if a drug can safely & effectively treat PTSD. See NCT05422612 for more info.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Fluoxetine can cause side effects like nausea, headaches, sleep disturbances, anxiety, and sexual dysfunction. The severity of these side effects varies from person to person.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Absolute change in the Clinician-Administered PTSD Scale-5-Revised (CAPS-5-R) Past Month total score at Week 12 (Final/Early termination Visit).
Incidence of new or worsening suicidal thoughts or behaviors as measured by change in Columbia Suicide Severity Rating Scale (C-SSRS) score from baseline.
Secondary outcome measures
Frequency of serious adverse events (SAEs).
Frequency of treatment-emergent adverse events (TEAEs).
Number of participants Achieving Remission
+5 moreSide effects data
From 2016 Phase 4 trial • 8 Patients • NCT0183389738%
sedation
25%
headache
13%
phosphenes
13%
hypomania
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ketamine and DCS Treatment
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Intervention A: Fluoxetine HClExperimental Treatment1 Intervention
Group II: Intervention A PlaceboPlacebo Group1 Intervention
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Who is running the clinical trial?
Idorsia Pharmaceuticals Ltd.Industry Sponsor
119 Previous Clinical Trials
34,352 Total Patients Enrolled
CitelineUNKNOWN
3 Previous Clinical Trials
1,000 Total Patients Enrolled
U.S. Army Medical Research and Development CommandLead Sponsor
287 Previous Clinical Trials
245,709 Total Patients Enrolled
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