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Risperdal Consta and Health Care Utilization in Patients With Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00313391
Recruitment Status : Completed
First Posted : April 12, 2006
Last Update Posted : September 25, 2014
Janssen, L.P. - Investigator Initiated Studies Program
Information provided by:
Emory University

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Drug: Risperdal Consta Phase 4

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Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: The Effects of Risperdal Consta on Health Care Utilization Costs in Chronically Ill Schizophrenic Patients
Study Start Date : December 2005
Actual Primary Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Risperidone

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00313391

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

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Responsible Party: Dragan Bugarski-Kirola, MD, Emory University Identifier: NCT00313391    
Other Study ID Numbers: 731-2005
First Posted: April 12, 2006    Key Record Dates
Last Update Posted: September 25, 2014
Last Verified: September 2014
Additional relevant MeSH terms:
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Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents