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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Stress Disorders, Post-Traumatic
 Drug: Paroxetine
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Secondary Prevention With Paroxetine vs. Placebo in Subthreshold Posttraumatic Stress Disorder (PTSD)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Durham VA Medical Center:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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



Enrollment: 12
Study Start Date: January 2006
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Placebo Comparator: Placebo Drug: Placebo
Placebo: same as paroxetine (active comparator)

Detailed Description:

See brief summary

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00560612

Locations
United States, North Carolina
Durham VAMC
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Durham VA Medical Center
Investigators
Principal Investigator: Christine E Marx, MD, MA Durham VAMC
  More Information

No publications provided

Responsible Party: Christine E. Marx, MD, Durham Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT00560612     History of Changes
Other Study ID Numbers: VA IRB# 00993
Study First Received: November 19, 2007
Results First Received: November 30, 2010
Last Updated: March 31, 2011
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Durham VA Medical Center:
PTSD
Paroxetine
Subthreshold

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Paroxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013