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.

Study Overview

• Status: Completed
• Conditions: Stress Disorders, Post-Traumatic
• Intervention / Treatment: Drug: Paroxetine; Drug: Placebo

Detailed Description

See brief summary

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Durham VAMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Durham VA Medical Center
• Investigators: Principal Investigator: Christine E Marx, MD, MA, Durham VAMC

Study record dates

Study Major Dates

• Study Start: January 1, 2006
• Primary Completion (Actual): July 1, 2008
• Study Completion (Actual): July 1, 2008

Study Registration Dates

• First Submitted: November 19, 2007
• First Submitted That Met QC Criteria: November 19, 2007
• First Posted (Estimate): November 20, 2007

Study Record Updates

• Last Update Posted (Actual): June 18, 2019
• Last Update Submitted That Met QC Criteria: May 24, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: PTSD; Paroxetine; Subthreshold
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Paroxetine
• Other Study ID Numbers: VA IRB# 00993