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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


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) scores

Clinical 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) scores

Change 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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Page last updated: August 23, 2015

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