Clinical trial NCT00230893: Characterization of the Use of Antipsychotics in PTSD During the Past Seven Years
Official title: Characterization of the Use of Antipsychotics in PTSD During the Past Seven Years
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: PTSD
Post-Traumatic Stress Disorder
Keywords: Antipsychotics
PTSD
Post Traumatic Stress Disorder
monotherapy
adjunct therapy
Lead sponsor: Tuscaloosa Research & Education Advancement Corporation
Sponsor class: OTHER
Collaborators: name: Janssen, LP
First posted: 2005-10-03
Enrollment: 99
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: RETROSPECTIVE

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

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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tuscaloosa
country: United States
facility: Tuscaloosa VA Medical Center
state: Alabama
Study officials:
affiliation: Tuscaloosa Veterans Affairs Medical Center
name: Lori L. Davis, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kozaric-Kovacic D, Pivac N, Muck-Seler D, Rothbaum BO. Risperidone in psychotic combat-related posttraumatic stress disorder: an open trial. J Clin Psychiatry. 2005 Jul;66(7):922-7. doi: 10.4088/jcp.v66n0716.