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

Primary Purpose

Stress Disorders, Post-Traumatic

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Paroxetine
Placebo
Sponsored by
Durham VA Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stress Disorders, Post-Traumatic focused on measuring PTSD, Paroxetine, Subthreshold

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Durham VAMC

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Paroxetine

Placebo

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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 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 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.

Full Information

First Posted
November 19, 2007
Last Updated
May 24, 2019
Sponsor
Durham VA Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00560612
Brief Title
Secondary Prevention With Paroxetine vs. Placebo in Subthreshold Posttraumatic Stress Disorder (PTSD)
Official Title
Secondary Prevention With Paroxetine vs. Placebo in Subthreshold Posttraumatic Stress Disorder (PTSD)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Durham VA Medical Center

4. Oversight

5. Study Description

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.
Detailed Description
See brief summary

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Post-Traumatic
Keywords
PTSD, Paroxetine, Subthreshold

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Paroxetine
Arm Type
Active Comparator
Arm Description
Paroxetine 10 mg-40 mg or placebo; flexible dosing; 12-week duration.
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Paroxetine
Intervention Description
Paroxetine 10 mg-40 mg or placebo; flexible dosing; 12-week duration.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo: same as paroxetine (active comparator)
Primary Outcome Measure Information:
Title
Change in Clinician Administered PTSD Scale (CAPS) Scores
Description
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.
Time Frame
Change in Scores (12 weeks-Baseline)
Secondary Outcome Measure Information:
Title
Change in Short PTSD Rating Interview Scores
Description
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.
Time Frame
Change in Scores (12 weeks-Baseline)
Title
Change in Connor Davidson Resilience Scale Scores
Description
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.
Time Frame
Change in Scores (12 Weeks-Baseline)
Title
Change in Hospital Anxiety and Depression Scale Scores
Description
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.
Time Frame
Change in Scores (12 Weeks-Baseline)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine E Marx, MD, MA
Organizational Affiliation
Durham VAMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Durham VAMC
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States

12. IPD Sharing Statement

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

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