Official Title: “Secondary Prevention With Paroxetine vs. Placebo in Subthreshold PTSD”

The purpose of this study is: 1) To document the effectiveness and tolerability of paroxetine for the treatment of subthreshold PTSD in veterans in the early post-deployment period; and 2) To determine the potential efficacy of paroxetine in preventing the progression of anxiety symptoms to PTSD and other anxiety disorders, and improving overall veteran function.

Study Type: Interventional

Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment

Study Primary Completion Date: July 2008

See brief summary

Intervention(s) in this Clinical Trial

• Drug: Paroxetine or Placebo
  • Paroxetine 10 mg-40 mg or placebo; flexible dosing; 12-week duration.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
• Placebo Comparator: 2

Primary Measures

• The primary outcome will be improvement in PTSD symptoms as determined by the Clinician Administered PTSD Scale (CAPS).
  • Time Frame: 12 weeks
    Safety Issue?: No

Secondary Measures

• Short PTSD Rating Interview, the Clinical Global Impressions of Severity and of Improvement Scales, Hospital Anxiety and Depression Scale, Connor Davidson Resilience Scale, the Symptom Checklist 90, and Sheehan Disability Scale (SDS)
  • Time Frame: 12 weeks
    Safety Issue?: No

Inclusion Criteria:

• 1. Veterans 18-55 years of age
• 2. Diagnosis of subthreshold PTSD (at least one symptom in PTSD symptom clusters B, C, and D by structured interview; with or without functional impairment exposure to war zone stressors)
• 3. Written informed consent; and 4. A negative serum pregnancy test for women of childbearing potential.

Exclusion Criteria:

• 1. Lifetime history of DSM-IV diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, or cognitive disorder due to a general medical condition
• 2. History of substance dependence within the last 3 months
• 3. Significant suicide risk or serious suicide attempt within the last year
• 4. Clinically significant medical condition or laboratory or EKG abnormality
• 5. Women of childbearing potential who are unwilling to practice an acceptable method of contraception
• 6. Subjects needing concurrent use of psychiatric medications
• 7. History of hypersensitivity to paroxetine
• 8. HADS depression subscale score > 12
• 9. Failure to respond to an adequate trial of paroxetine (20 mg/day x 8 wks).

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 55 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Durham VA Medical Center

Overall Clinical Trial Officials and Contacts

Christine E Marx, MD, MA Principal Investigator Durham VAMC  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00560612

Study ID Number: VA IRB# 00993

ClinicalTrials.gov Identifier: NCT00560612

Health Authority: United States: Federal Government