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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00560612
Recruitment Status : Completed
First Posted : November 20, 2007
Results First Posted : January 25, 2011
Last Update Posted : February 1, 2018
Information provided by (Responsible Party):
Durham VA Medical Center

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.

Condition or disease Intervention/treatment Phase
Stress Disorders, Post-Traumatic Drug: Paroxetine Drug: Placebo Phase 4

Detailed Description:
See brief summary

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Secondary Prevention With Paroxetine vs. Placebo in Subthreshold Posttraumatic Stress Disorder (PTSD)
Study Start Date : January 2006
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Arm Intervention/treatment
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)

Primary Outcome Measures :
  1. Clinician Administered PTSD Scale (CAPS) [ Time Frame: Baseline and 12 weeks ]

    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 :
  1. Short PTSD Rating Interview [ Time Frame: 12 weeks ]

    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).

  2. Connor Davidson Resilience Scale [ Time Frame: 12 weeks ]
    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.

  3. Hospital Anxiety and Depression Scale [ Time Frame: 12 weeks ]
    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).

  4. Clinical Global Impressions of Severity and of Improvement Scales [ Time Frame: 12 weeks ]

    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.

  5. Symptom Checklist 90 [ Time Frame: 12 weeks ]

    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.

  6. Sheehan Disability Scale (SDS) [ Time Frame: 12 weeks ]

    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00560612

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

Responsible Party: Durham VA Medical Center Identifier: NCT00560612     History of Changes
Other Study ID Numbers: VA IRB# 00993
First Posted: November 20, 2007    Key Record Dates
Results First Posted: January 25, 2011
Last Update Posted: February 1, 2018
Last Verified: January 2018

Keywords provided by Durham VA Medical Center:

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors