Status:
UNKNOWN
Predictors of Treatment Response to Fluoxetine in PTSD Following a Recent History of War Zone Stress Exposure
Lead Sponsor:
TEMPVA Research Group, Inc.
Collaborating Sponsors:
C.R.Darnall Army Medical Center
Central Texas Veterans Health Care System
Conditions:
Posttraumatic Stress Disorder, Combat-related
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 sol...
Detailed Description
While most soldiers exposed to the stresses of the war-zone exhibit psychological resilience, about one-fifth become psychological casualties of war. The fact that such a significant number of soldier...
Eligibility Criteria
Inclusion
- Veteran of the OEF/OIF war campaigns with violence exposure sufficient to qualify for a diagnosis of PTSD
- DSM-IV diagnosis of Post-Traumatic Stress Disorder as determined by the CAPS.
- Entry Total CAPS score of at least 65
- No exposure to psychotropic medications except for zolpidem for at least two weeks (five weeks for fluoxetine) prior to the baseline assessments.
- If female, a negative beta-human chorionic gonadotropin pregnancy test and willing to use oral contraceptives
Exclusion
- History of intolerance to fluoxetine
- History of lack of responsivity to a 60 mg daily dose of fluoxetine
- Current or past history of Bipolar Disorder or Schizophrenia
- Diagnosis of Major Depressive Disorder, Obsessive-Compulsive Disorder, or Other Anxiety Disorder, unless PTSD is the principal focus of treatment and the onset of PTSD preceded that of the concurrent disorders
- Significant history of suicidal or homicidal behavior/ideation
- Substance dependence in the past 6 months
- Serious general medical condition that would risk the patient being able to complete the pharmacological trial with fluoxetine
- Concomitant use of other antidepressants, antipsychotics or mood stabilizers
- If female, pregnancy or unwilling to use oral contraceptives
- Participation in another research drug trial within 30-days of enrollment
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2012
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00633685
Start Date
March 1 2010
End Date
August 1 2012
Last Update
May 25 2010
Active Locations (1)
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1
Carl R. Darnall Army Medical Center
Fort Hood, Texas, United States, 76544-4752