Characterization of the Use of Antipsychotics in PTSD Dur... | NCT00230893

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

NCT00230893

Sponsor

Tuscaloosa Research & Education Advancement Corporation

Status

Completed

Last Update Posted

Sep 21, 2006Estimated

Enrollment

Phase

Not provided

Conditions

PTSD
Post-Traumatic Stress Disorder

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
TREAC - PTSD Retrospective

Status Module

Record Verification Date

Sep 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2005

Primary Completion Date

Not provided

Completion Date

Sep 2005

First Submitted Date

Sep 29, 2005

First Submission Date that Met QC Criteria

Sep 29, 2005

First Posted Date

Oct 3, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 20, 2006

Last Update Posted Date

Sep 21, 2006Estimated

Name	Class
Janssen, LP	INDUSTRY

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lori L. Davis, MD	Tuscaloosa Veterans Affairs Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tuscaloosa VA Medical Center		Tuscaloosa	Alabama	35404	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16013909	Background	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.

ID	Term
D040921	Stress Disorders, Traumatic
D000068099	Trauma and Stressor Related Disorders
D001523	Mental Disorders