Risperdal Consta and Health Care Utilization in Patients With Schizophrenia

This study has been completed.
Sponsor:
Collaborator:
Janssen, L.P. - Investigator Initiated Studies Program
Information provided by:
Emory University
ClinicalTrials.gov Identifier:
NCT00313391
First received: April 10, 2006
Last updated: December 6, 2010
Last verified: April 2006
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Schizoaffective Disorder
Drug: Risperdal Consta
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: The Effects of Risperdal Consta on Health Care Utilization Costs in Chronically Ill Schizophrenic Patients

Resource links provided by NLM:


Further study details as provided by Emory University:

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00313391

Locations
United States, Georgia
Grady Hospital
Atlanta, Georgia, United States
Sponsors and Collaborators
Emory University
Janssen, L.P. - Investigator Initiated Studies Program
Investigators
Principal Investigator: Dragana Bugarski-Kirola, MD Emory University
  More Information

No publications provided

Responsible Party: Dragan Bugarski-Kirola, MD, Emory University
ClinicalTrials.gov Identifier: NCT00313391     History of Changes
Other Study ID Numbers: 731-2005
Study First Received: April 10, 2006
Last Updated: December 6, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on April 16, 2014