Overview

Secondary Prevention With Paroxetine vs. Placebo in Subthreshold Posttraumatic Stress Disorder (PTSD)

Status:
Completed

Trial end date:
2008-07-01

Target enrollment:
0

Participant gender:
All

Summary

The purpose of this study is: 1) To document the effectiveness and tolerability of paroxetine for the treatment of subthreshold posttraumatic stress disorder (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.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Durham VA Medical Center

Treatments:

Paroxetine

Criteria

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).