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Characterization of the Use of Antipsychotics in PTSD During the Past Seven Years

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ClinicalTrials.gov Identifier: NCT00230893
Recruitment Status : Completed
First Posted : October 3, 2005
Last Update Posted : September 21, 2006
Sponsor:
Collaborator:
Janssen, LP
Information provided by:
Tuscaloosa Research & Education Advancement Corporation

Brief Summary:
The primary objective is to examine the percentage of patients with PTSD who were prescribed an antipsychotic over the past seven years in the VA Network 7 (AL, GA, SC) and compare the percentage on an annual basis. We will also determine the type and dose of antipsychotics received. We hypothesize that there has been a significant increase in antipsychotic use, especially atypical antipsychotics, prescribed for patients with PTSD over the last 7 years

Condition or disease
PTSD Post-Traumatic Stress Disorder

Detailed Description:

This study is a retrospective electronic review of the VISN 7 Data Warehouse to determine what have been the emerging trends in prescriptions of atypical antipsychotic medications over the past seven years for the treatment of posttraumatic stress disorder (PTSD) in the VA

This study is a retrospective electronic review of patients of the VISN 7 Data Warehouse of patients with a diagnosis of PTSD treated with antipsychotics as monotherapy or adjunctive therapy at a VA Medical Center or VA clinic in VISN 7 (GA, SC, and AL). The data will be retrieved from a computerized list of patients treated in VA VISN 7 for PTSD from 1998-2005 and cross-referenced with the electronic pharmacy file for having received a prescription of an antipsychotic medication. No personal identifiers will be collected. The data will then be examined to determine what type of antipsychotics were prescribed and the dose and duration of the antipsychotics. In addition, demographics and clinical characteristics available through the Data Warehouse will be collected.


Study Type : Observational
Enrollment : 99 participants
Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Retrospective
Official Title: Characterization of the Use of Antipsychotics in PTSD During the Past Seven Years
Study Start Date : July 2005
Study Completion Date : September 2005




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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female patients, any race or ethnic origin at least 19 years of age.
  • Patients with a diagnosis of PTSD
  • Treated with an antipsychotic as a monotherapy or adjunctive therapy
  • Patient must have been seen at a VA medical center or clinic within VISN 7 during the study period.

Exclusion Criteria:

  • Patients not diagnosed with PTSD
  • Not treated with an antipsychotic as a monotherapy or adjunctive therapy
  • Patients outside of Network 7
  • Patients with a diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder

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): NCT00230893


Locations
United States, Alabama
Tuscaloosa VA Medical Center
Tuscaloosa, Alabama, United States, 35404
Sponsors and Collaborators
Tuscaloosa Research & Education Advancement Corporation
Janssen, LP
Investigators
Principal Investigator: Lori L. Davis, MD Tuscaloosa VA Medical Center

Publications:
ClinicalTrials.gov Identifier: NCT00230893     History of Changes
Other Study ID Numbers: TREAC - PTSD Retrospective
First Posted: October 3, 2005    Key Record Dates
Last Update Posted: September 21, 2006
Last Verified: September 2006

Keywords provided by Tuscaloosa Research & Education Advancement Corporation:
Antipsychotics
PTSD
Post Traumatic Stress Disorder
monotherapy
adjunct therapy

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs