Risperdal Consta and Health Care Utilization in Patients With Schizophrenia

NCT ID: NCT00313391

Last Updated: 2014-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-12-31

Brief 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.

Conditions

Schizophrenia; Schizoaffective Disorder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Interventions

Risperdal Consta

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen, L.P. - Investigator Initiated Studies Program

UNKNOWN

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Emory University

Principal Investigators

Dragana Bugarski-Kirola, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Grady Hospital

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

731-2005

Identifier Type: -

Identifier Source: org_study_id