Observational Study in Patients With Schizophrenia Treated With Long-Acting Risperidone Injection (RISPERDAL CONSTA)
Information source: Janssen, LP
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia
Intervention: risperidone (RISPERDAL CONSTA) (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Janssen, LP Official(s) and/or principal investigator(s): Janssen, LP Clinical Trial, Study Director, Affiliation: Janssen, LP
Summary
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 over a two-year period of observation.
Clinical Details
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)
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Change from baseline to 24 months in Clinical Global Impression of Severity (CGI-S) scoresClinical Global Impression of Change (CGI-C) scores during 24 months Change from baseline to 24 months in Global Assessment of Function (GAF) scores Change from baseline to 24 months in Personal and Social Performance (PSP) scores Change from baseline to 24 months in Strauss-Carpenter Levels of Function (LOF) scores
Secondary outcome: Change from baseline to 24 months in Quality of Life Assessment: Medical Outcomes Survey Short Form (SF-36) scoresChange from baseline to 24 months in patient satisfaction with antipsychotic medication Change from baseline to 24 months in healthcare resource utilization
Detailed description:
This is a 2-year, prospective (a study in which the patients are identified and then
followed forward in time for the outcome of the study), multi-center (at multiple sites),
longitudinal (study that involves repeated observations of the same outcomes in the same
people over long periods of time), observational study (study in which the investigators/
physicians observe the patients and measure their outcomes) in adults with schizophrenia
(mental disorder characterized by a breakdown of thought processes and by poor emotional
responsiveness). Physicians will determine the appropriate treatment for their patients,
according to their usual practice. Patients starting treatment with long-acting risperidone
injection (an antipsychotic medication) and meeting all the study criteria will be enrolled
in the study. They will receive 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 (eg, emergency room visits and hospitalizations)
patient work status, quality of life and patient satisfaction with the medicine. Safety
will be monitored throughout the study duration of 2 years.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients had schizophrenia (disorganized, catatonic, paranoid, residual, or
undifferentiated) that met disease diagnostic criteria as defined in Diagnostic and
Statistical Manual of Mental Disorders IV ([DSM-IV]
- Requiring new treatment with long-acting risperidone injectable
- Patients were cooperative, reliable, and able to complete all aspects of the protocol
Exclusion Criteria:
- Use of an investigational drug in the past 30 days
- At risk to self or others
Locations and Contacts
Rockville, Maryland, United States
Additional Information
The SOURCE Study: Schizophrenia Outcomes-Utilization, Relapse, and Clinical Evaluation
Starting date: September 2004
Last updated: April 2, 2014
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