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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 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

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 more

Side effects data

From 2016 Phase 4 trial • 8 Patients • NCT01833897
38%
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

Find a Location

Who is running the clinical trial?

Idorsia Pharmaceuticals Ltd.Industry Sponsor
118 Previous Clinical Trials
32,257 Total Patients Enrolled
CitelineUNKNOWN
3 Previous Clinical Trials
1,000 Total Patients Enrolled
U.S. Army Medical Research and Development CommandLead Sponsor
286 Previous Clinical Trials
245,559 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are the doors still open for participants to join this clinical investigation?

"According to clinicaltrials.gov, this trial is actively seeking enrolment and was initially published on November 1st 2023 with recent modifications made on the 3rd of that same month."

Answered by AI

Which criteria must potential participants meet to join this clinical trial?

"This trial is searching for 200 participants aged 18 to 65 who are living with post-traumatic stress disorder. Other than the conditions outlined in the NCT05422612 Master Protocol, no other criteria must be met to join this study."

Answered by AI

What are the desired outcomes of this experiment?

"According to the trial sponsor, PPD's primary goal is assessing any modifications in Columbia Suicide Severity Rating Scale (C-SSRS) scores over a 12 week period. Additionally, they'll be looking into secondary outcomes such as frequency of Serious Adverse Events (SAEs), changes from baseline on Clinician Administered PTSD scale for DSM-5 Revised (CAPS-5-R) Past Month total score and severity of Treatment Emergent Adverse Events (TEAEs)."

Answered by AI

What is the cap on participants for this research project?

"Affirmative, the data hosted on clinicaltrials.gov demonstrates this medical study is recruiting participants. It was published on November 1st 2023 and modified for the last time three days later. This trial needs a total of 200 patients from one specific site to be enrolled."

Answered by AI

Has the United States Food and Drug Administration sanctioned Fluoxetine HCl?

"Given the Phase 2 study status of Intervention A: Fluoxetine HCl, our team has determined its safety to be a score of 2 on a scale from 1-3. This reflects that there is some data supporting safety but none affirming efficacy."

Answered by AI

Is this research open to participants who are fifty or older?

"This clinical trial only accepts participants within the age range of 18 to 65. However, there are 40 and 323 studies respectively for patients younger or older than this specific demographic."

Answered by AI

Who else is applying?

What site did they apply to?
Advanced Discovery Research
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Department of Defense PTSD Adaptive Platform Trial Intervention A - Fluoxetine
2023. "Department of Defense PTSD Adaptive Platform Trial Intervention A - Fluoxetine". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05948553.
All > Prozac
~133 spots leftby Mar 2026
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