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

This study has been completed.
Sponsor:
Information provided by:
Durham VA Medical Center
ClinicalTrials.gov Identifier:
NCT00560612
First received: November 19, 2007
Last updated: March 31, 2011
Last verified: March 2011

November 19, 2007
March 31, 2011
January 2006
July 2008   (final data collection date for primary outcome measure)
Clinician Administered PTSD Scale (CAPS) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]

Mean change scores in posttraumatic stress disorder symptoms. 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 primary outcome will be improvement in PTSD symptoms as determined by the Clinician Administered PTSD Scale (CAPS). [ Time Frame: 12 weeks ]
Complete list of historical versions of study NCT00560612 on ClinicalTrials.gov Archive Site
  • Short PTSD Rating Interview [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

    8 questions rated on 0-4 scale (0=not at all; 4=very much). One question assesses how much better the subject feels since beginning treatment (0-100; 0= no change; 100= very much change). Final question assesses how much symptoms have improved since starting treatment (forced choice: worse; no change; minimally; much; very much).

    Total score is computed from questions #1-8 (range=0-32).

  • Connor Davidson Resilience Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.
  • Hospital Anxiety and Depression Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Separate depression and anxiety scores are determined from this measure. Possible ranges for both depression and anxiety scores: 0-21. 0-7 (normal); 8-10 (borderline abnormal); 11-21 (abnormal).
  • Clinical Global Impressions of Severity and of Improvement Scales [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

    The severity of illness is rated on a scale of 1-7; 1 being normal and 7 being among the most extremely ill patients.

    Global improvement is similarly rated on a scale of 1-7; 1 being very much improved and 7 being very much worse.

  • Symptom Checklist 90 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

    Individual symptom scales are determined (via computer scoring) as follows:

    SOM - Somatization O-C - Obsessive-Compulsive I-S - Interpersonal Sensitivity DEP - Depression ANX - Anxiety HOS - Hostility PHOB - Phobic Anxiety PAR - Paranoid Ideation PSY - Psychoticism

    Global Indices Global Severity Index (GSI): Designed to measure overall psychological distress.

    Positive Symptom Distress Index (PSDI): Designed to measure the intensity of symptoms.

    Positive Symptom Total (PST): Reports number of self-reported symptoms.

  • Sheehan Disability Scale (SDS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

    Rates the following (scale 1-10; 1= not at all, 10=extremely) Work, Social Life, Family Life/Home Responsibilities.

    Perceived Stress and Social Supports Scale (scale 1-10; 1= not at all, 10=extremely) Perceived stress, perceived social support

Short PTSD Rating Interview, the Clinical Global Impressions of Severity and of Improvement Scales, Hospital Anxiety and Depression Scale, Connor Davidson Resilience Scale, the Symptom Checklist 90, and Sheehan Disability Scale (SDS) [ Time Frame: 12 weeks ]
Not Provided
Not Provided
 
Secondary Prevention With Paroxetine vs. Placebo in Subthreshold Posttraumatic Stress Disorder (PTSD)
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.

See brief summary

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Stress Disorders, Post-Traumatic
  • Drug: Paroxetine
    Paroxetine 10 mg-40 mg or placebo; flexible dosing; 12-week duration.
  • Drug: Placebo
    Placebo: same as paroxetine (active comparator)
  • Active Comparator: Paroxetine
    Paroxetine 10 mg-40 mg or placebo; flexible dosing; 12-week duration.
    Intervention: Drug: Paroxetine
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
July 2008
July 2008   (final data collection date for primary outcome measure)

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).
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00560612
VA IRB# 00993
Not Provided
Christine E. Marx, MD, Durham Veterans Affairs Medical Center
Durham VA Medical Center
Not Provided
Principal Investigator: Christine E Marx, MD, MA Durham VAMC
Durham VA Medical Center
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP