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

Phase 4

Completed

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

Veterans 18-55 years of age
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)
Written informed consent; and
A negative serum pregnancy test for women of childbearing potential.

Exclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Paroxetine	Paroxetine	Paroxetine 10 mg-40 mg or placebo; flexible dosing; 12-week duration.

Primary Outcome Measures

Name	Time	Method
Change in Clinician Administered PTSD Scale (CAPS) Scores	Change in Scores (12 weeks-Baseline)	Mean change scores in posttraumatic stress disorder symptoms. Raw scores may range from 0 (no symptoms) to 136 (severe symptoms; score of 136 is based on the first 17 CAPS items administered). A reduced CAPS score indicates a reduction in (improvement) PTSD symptoms, while an increase in CAPS score indicates an increase (worsening) in PTSD symptoms. The outcome measure is the change in scores before and after treatment. That is, the baseline and at 12 weeks difference scores.

Secondary Outcome Measures

Name	Time	Method
Change in Connor Davidson Resilience Scale Scores	Change in Scores (12 Weeks-Baseline)	This scale measures resilience. Range of scores (0-100). A score of 0 is suggestive of no resilience, a score of 100 is suggestive of high level of resilience. The outcome measure is the change in scores before and after treatment. That is, the baseline and Visit 6 difference scores.
Change in Short PTSD Rating Interview Scores	Change in Scores (12 weeks-Baseline)	The SPRINT contains 8 questions which are rated on a 0-4 scale (0=not at all; 4=very much). The total score is computed from summing questions #1-8 (range=0-32). The higher the total score, the worse the symptoms. The outcome measure is the change in scores before and after treatment. That is, the baseline and Visit 6 difference scores.
Change in Hospital Anxiety and Depression Scale Scores	Change in Scores (12 Weeks-Baseline)	The total HADS score is presented, which is regarded as a global measure of psychological distress. The total score ranges from 0-42. Each individual question is rated on a 4 point scale (0=absent to 3 =extreme presence). The higher the score, the greater level of psychological distress. The outcome measure is the change in scores before and after treatment. That is, the baseline and Visit 6 difference scores.