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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00230893
Other study ID # TREAC - PTSD Retrospective
Secondary ID TREAC - PTSD Ret
Status Completed
Phase N/A
First received September 29, 2005
Last updated September 20, 2006
Start date July 2005
Est. completion date September 2005

Study information

Verified date September 2006
Source Tuscaloosa Research & Education Advancement Corporation
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 99
Est. completion date September 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 19 Years and older
Eligibility 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

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal


Locations

Country Name City State
United States Tuscaloosa VA Medical Center Tuscaloosa Alabama

Sponsors (2)

Lead Sponsor Collaborator
Tuscaloosa Research & Education Advancement Corporation Janssen, LP

Country where clinical trial is conducted

United States, 

References & Publications (1)

Kozaric-Kovacic D, Pivac N, Mück-Seler D, Rothbaum BO. Risperidone in psychotic combat-related posttraumatic stress disorder: an open trial. J Clin Psychiatry. 2005 Jul;66(7):922-7. — View Citation

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