MedTrace Logo

Predictors of Treatment Response to Fluoxetine in PTSD Following a Recent History of War Zone Stress Exposure

NCT00633685 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2010-05-25

No results posted yet for this 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.

Conditions

  • Posttraumatic Stress Disorder, Combat-related

Interventions

DRUG

Fluoxetine

Fluoxetine will be administered at 20-60 mg daily for 12 weeks in a flexible dosage schedule based upon clinical response

DRUG

Placebo

Placebo will be empty gelatin capsules that are identical in size and shape to active treatment

Sponsors & Collaborators

  • C.R.Darnall Army Medical Center

    collaborator FED

  • Central Texas Veterans Health Care System

    collaborator OTHER

  • VA Boston Healthcare System

    collaborator FED

  • TEMPVA Research Group, Inc.

    lead OTHER

Principal Investigators

  • Paul B Hicks, M.D., Ph.D. · Central Texas Veterans Health Care System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2012-06-30
Completion
2012-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00633685 on ClinicalTrials.gov