Risperdal Consta and Health Care Utilization in Patients With Schizophrenia

Schizophrenia Clinical Trial

Official title:

The Effects of Risperdal Consta on Health Care Utilization Costs in Chronically Ill Schizophrenic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00313391
• Other study ID #: 731-2005
• Status: Completed
• Phase: Phase 4
• First received: April 10, 2006
• Last updated: September 23, 2014
• Start date: December 2005

Study information

• Verified date: September 2014
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if Risperdal Consta will affect the healthcare utilization costs in chronically ill schizophrenic patients with multiple admissions to the psychiatric hospital compared to the previous utilization costs under standard oral treatment of any atypical antipsychotic. We hypothesize that higher Risperdal Consta acquisition costs can be offset by reduction in total medical utilization costs, such as hospitalizations, ER visits, unscheduled outpatient visits or incarcerations due to worsening of psychotic symptoms.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: December 2007
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Primary diagnosis of schizophrenia or schizoaffective disorder

• 4 or more admissions to psychiatric hospital in past year, OR minimum of 2 hospital admissions and at least 2 incarcerations in the previous year

• Medicaid recipient

• Patients requiring concomitant non-antipsychotic psychotropic medication (mood stabilizing, antidepressants, anxiolytics)

Exclusion Criteria:

• Past or current psychiatric disorder, other than schizophrenia or schizoaffective disorder

• Drug or alcohol dependence

• Serious, unstable medical illness or any acute medical condition

• Pregnant or lactating females

• Prior Risperdal Consta treatment

• Non-English speaking

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Drug:
• Risperdal Consta

Locations

Country	Name	City	State
United States	Grady Hospital	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	Janssen, L.P. - Investigator Initiated Studies Program

Country where clinical trial is conducted

United States,