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A 2-Year Study of Patients With Schizophrenia Who Are Treated With Long-Acting Risperidone Injection.
This study has been completed.
Sponsored by: Janssen, LP
Information provided by: Janssen, LP
ClinicalTrials.gov Identifier: NCT00246194
  Purpose

The purpose of this study is to examine treatment practices of adult schizophrenia patients by their own doctors, and to assess patient outcomes when treated with long-acting risperidone injection (an antipsychotic medication) over a two-year period of observation.


Condition Phase
Schizophrenia
Phase IV

MedlinePlus related topics: Schizophrenia
Drug Information available for: Risperidone
U.S. FDA Resources
Study Type: Observational
Study Design: Prospective
Official Title: The SOURCE Study: Schizophrenia Outcomes-Utilization, Relapse, and Clinical Evaluation: a Prospective 2-Year Observational Study of Patients With Schizophrenia Who Initiate Treatment With Injectable Risperidone Long-Acting Microspheres (RISPERDAL® CONSTA™)

Further study details as provided by Janssen, LP:

Estimated Enrollment: 600
Study Start Date: September 2004
Study Completion Date: November 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Detailed Description:

Controlled clinical trials for treating schizophrenia often involve selected patients with common characteristics. It is recognized that schizophrenia patients are much more diverse than those in the clinical setting, and that physicians' prescribing practices may vary. The objective of the study is to examine treatment practices for adult schizophrenic patients by their own physicians, and to assess patient outcomes when treated with long-acting risperidone injection. This is a 2-year, prospective, multi-center, longitudinal, observational study in adults with schizophrenia. Physicians will determine the appropriate treatment for their patients, according to their usual practice. Patients starting treatment with long-acting risperidone injection and meeting all the study criteria may enroll in the study. They will be administered a dose of 25, 37.5 or 50 mg of risperidone every 2 weeks by intramuscular injection, and continue their treatment for schizophrenia according to usual care by their physicians. Patients will be asked questions at baseline and every three months for a period of two years to assess: efficacy of the medication, how well the patient is functioning, use of healthcare resources (e.g., emergency room visits, hospitalizations) patient work status, quality of life and patient satisfaction with the medicine. Safety will be monitored throughout the study.

A dose of 25, 37.5 or 50 mg of risperidone, administered every 2 weeks by intramuscular injection. The study duration is 2 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of schizophrenia
  • Requiring new treatment with long-acting risperidone injectable
  • If female, using birth control

Exclusion Criteria:

  • Use of an investigational drug in the past 30 days
  • At risk to self or others
  • Pregnant or breast-feeding
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00246194

Sponsors and Collaborators
Janssen, LP
Investigators
Study Director: Janssen, LP Clinical Trial Janssen, LP
  More Information

Study ID Numbers: CR005035
Study First Received: October 28, 2005
Last Updated: October 3, 2008
ClinicalTrials.gov Identifier: NCT00246194  
Health Authority: United States: Institutional Review Board

Keywords provided by Janssen, LP:
treatment outcome
long-acting risperidone
Schizophrenia
intramuscular injections

Study placed in the following topic categories:
Schizophrenia
Dopamine
Mental Disorders
Risperidone
Psychotic Disorders
Serotonin
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:
Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Dopamine Antagonists
Antipsychotic Agents
Pharmacologic Actions
Serotonin Antagonists
Serotonin Agents
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009