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

PTSD Clinical Trial

Official title:

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

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
• 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

Related Conditions & MeSH terms

• Post-Traumatic Stress Disorder
• PTSD
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

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