COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT00560612
Recruitment Status : Completed
First Posted : November 20, 2007
Results First Posted : January 25, 2011
Last Update Posted : June 18, 2019
Sponsor:
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

Layout table for study information
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. Change in Clinician Administered PTSD Scale (CAPS) Scores [ Time Frame: Change in Scores (12 weeks-Baseline) ]

    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 :
  1. Change in Short PTSD Rating Interview Scores [ Time Frame: Change in Scores (12 weeks-Baseline) ]
    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.

  2. Change in Connor Davidson Resilience Scale Scores [ Time Frame: Change in Scores (12 Weeks-Baseline) ]
    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.

  3. Change in Hospital Anxiety and Depression Scale Scores [ Time Frame: Change in Scores (12 Weeks-Baseline) ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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).

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 ClinicalTrials.gov identifier (NCT number): NCT00560612


Locations
Layout table for location information
United States, North Carolina
Durham VAMC
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Durham VA Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Christine E Marx, MD, MA Durham VAMC
Layout table for additonal information
Responsible Party: Durham VA Medical Center
ClinicalTrials.gov Identifier: NCT00560612    
Other Study ID Numbers: VA IRB# 00993
First Posted: November 20, 2007    Key Record Dates
Results First Posted: January 25, 2011
Last Update Posted: June 18, 2019
Last Verified: May 2019
Keywords provided by Durham VA Medical Center:
PTSD
Paroxetine
Subthreshold
Additional relevant MeSH terms:
Layout table for MeSH terms
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Paroxetine
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