← Back to Search

Selective Serotonin Reuptake Inhibitor

Fluoxetine for Posttraumatic Stress Disorder (PTSD)

Phase 4
Waitlist Available
Led By Paul B Hicks, M.D., Ph.D.
Research Sponsored by TEMPVA Research Group, Inc.
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 every follow-up encounter (weeks 2-32)
Awards & highlights

Study Summary

Three hundred (300) male or female outpatients, over 18 years of age, will be enrolled in this study to determine whether fluoxetine can be used as a treatment for Posttraumatic Stress Disorder in soldiers recently returning from combat exposure. There will be two phases to the study. In Phase I Fluoxetine + usual psychological care will be compared with Placebo + usual psychological care over a 12-week period. Subsequently, in Phase II all subjects will be offered the opportunity to enroll in a 20-week open-label trial on Fluoxetine. If response is inadequate, adjunctive treatment with either buspirone or bupropion will be offered. The investigational drugs are Fluoxetine, Buspirone and Bupropion. All are commercially available.

Eligible Conditions
  • Posttraumatic Stress Disorder (PTSD)

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every follow-up encounter (weeks 2-32)
This trial's timeline: 3 weeks for screening, Varies for treatment, and every follow-up encounter (weeks 2-32) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinician Administered PTSD Scale
Secondary outcome measures
PTSD Symptom Checklist

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: FluoxetineExperimental Treatment2 Interventions
Receives Fluoxetine at 20-60 mg daily for 12 weeks in a flexible dosage schedule based upon clinical response
Group II: PlaceboPlacebo Group2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fluoxetine
FDA approved
Gelatin
FDA approved

Find a Location

Who is running the clinical trial?

Central Texas Veterans Health Care SystemOTHER
4 Previous Clinical Trials
1,035 Total Patients Enrolled
VA Boston Healthcare SystemFED
68 Previous Clinical Trials
970,152 Total Patients Enrolled
TEMPVA Research Group, Inc.Lead Sponsor
1 Previous Clinical Trials
25,732 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~20 spots leftby Apr 2025