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Completed

NCT Number: NCT00560612

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

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.

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Key information

Conditions

Stress Disorders, Post-Traumatic Mental Disorders Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Durham VAMC

Durham, North Carolina, 27705, United States

About this study

See brief summary

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

paroxetine

Drug

Paroxetine 10 mg-40 mg or placebo; flexible dosing; 12-week duration.

Placebo

Drug

Placebo: same as paroxetine (active comparator)

Primary outcomes

  1. Change in Clinician Administered PTSD Scale (CAPS) Scores

    Time frame: 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 outcomes

  1. Change in Short PTSD Rating Interview Scores

    Time frame: 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.

  2. Change in Connor Davidson Resilience Scale Scores

    Time frame: 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.

  3. Change in Hospital Anxiety and Depression Scale Scores

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Durham VA Medical Center

Fed

Registry information

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Nov 20, 2007
Registry last updated
Jun 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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