Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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: September 23, 2014
Last verified: September 2014
  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:

Study Start Date: December 2005
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: September 23, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 23, 2014