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

Study Overview
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Brief Summary
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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.

Detailed Description
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See brief summary

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

Conditions
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Stress Disorders, Post-Traumatic

Intervention / Treatment
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* Drug: Paroxetine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Paroxetine<br>Paroxetine 10 mg-40 mg or placebo; flexible dosing; 12-week duration. | Drug: Paroxetine<br>* Paroxetine 10 mg-40 mg or placebo; flexible dosing; 12-week duration.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo: same as paroxetine (active comparator)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Clinician Administered PTSD Scale (CAPS) Scores | 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. | Change in Scores (12 weeks-Baseline) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Short PTSD Rating Interview Scores | 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 Scores (12 weeks-Baseline) | 
| Change in Connor Davidson Resilience Scale Scores | 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 Scores (12 Weeks-Baseline) | 
| Change in Hospital Anxiety and Depression Scale Scores | 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. | Change in Scores (12 Weeks-Baseline) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PTSD, Paroxetine, Subthreshold