Posttraumatic Stress Disorder, Combat-related | Predictors of Treatment Response to Fluoxetine in PTSD Following a Recent History of War Zone Stress Exposure
Posttraumatic Stress Disorder, Combat-related research study
What is the primary objective of this study?
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.
Who is eligible to participate?
Inclusion Criteria: 1. Veteran of the OEF/OIF war campaigns with violence exposure sufficient to qualify for a diagnosis of PTSD 2. DSM-IV diagnosis of Post-Traumatic Stress Disorder as determined by the CAPS. 3. Entry Total CAPS score of at least 65 4. No exposure to psychotropic medications except for zolpidem for at least two weeks (five weeks for fluoxetine) prior to the baseline assessments. 5. If female, a negative beta-human chorionic gonadotropin pregnancy test and willing to use oral contraceptives Exclusion Criteria: 1. History of intolerance to fluoxetine 2. History of lack of responsivity to a 60 mg daily dose of fluoxetine 3. Current or past history of Bipolar Disorder or Schizophrenia 4. 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 5. Significant history of suicidal or homicidal behavior/ideation 6. Substance dependence in the past 6 months 7. Serious general medical condition that would risk the patient being able to complete the pharmacological trial with fluoxetine 8. Concomitant use of other antidepressants, antipsychotics or mood stabilizers 9. If female, pregnancy or unwilling to use oral contraceptives 10. Participation in another research drug trial within 30-days of enrollment
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Posttraumatic Stress Disorder, Combat-related
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:FluoxetineFluoxetine will be administered at 20-60 mg daily for 12 weeks in a flexible dosage schedule based upon clinical response
Drug:PlaceboPlacebo will be empty gelatin capsules that are identical in size and shape to active treatment
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
FluoxetineReceives Fluoxetine at 20-60 mg daily for 12 weeks in a flexible dosage schedule based upon clinical response
Start Date: March 2010
Completed Date: August 2012
Phase: Phase 4
Primary Outcome: Clinician Administered PTSD Scale
Secondary Outcome: PTSD Symptom Checklist
Study sponsors, principal investigator, and references
Principal Investigator: Paul B Hicks, M.D., Ph.D.
Lead Sponsor: TEMPVA Research Group, Inc.
Collaborator: C.R.Darnall Army Medical Center