Clinical trial NCT00246194: Observational Study in Patients With Schizophrenia Treated With Long-Acting Risperidone Injection (RISPERDAL CONSTA)
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Keywords: Schizophrenia
Mental disorder
DSM-IV
RISPERDAL CONSTA
Risperidone
Long-acting risperidone
Disorganized
Catatonic
Paranoid
Lead sponsor: Janssen, LP
Sponsor class: INDUSTRY
First posted: 2005-10-30
Enrollment: 532
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients diagnosed with schizophrenia

Brief 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.

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 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

Primary outcomes:
measure: Change from baseline to 24 months in Clinical Global Impression of Severity (CGI-S) scores
timeFrame: Baseline (Month 0) to 24 months
measure: Clinical Global Impression of Change (CGI-C) scores during 24 months
timeFrame: 24 months
measure: Change from baseline to 24 months in Global Assessment of Function (GAF) scores
timeFrame: Baseline to 24 months
measure: Change from baseline to 24 months in Personal and Social Performance (PSP) scores
timeFrame: Baseline to 24 months
measure: Change from baseline to 24 months in Strauss-Carpenter Levels of Function (LOF) scores
timeFrame: Baseline to 24 months
Secondary outcomes:
measure: Change from baseline to 24 months in Quality of Life Assessment: Medical Outcomes Survey Short Form (SF-36) scores
timeFrame: Baseline to 24 months
measure: Change from baseline to 24 months in patient satisfaction with antipsychotic medication
timeFrame: Baseline to 24 months
measure: Change from baseline to 24 months in healthcare resource utilization
timeFrame: Baseline to 24 months
Other outcomes:
Locations:
city: Rockville
country: United States
state: Maryland
Study officials:
affiliation: Janssen, LP
name: Janssen, LP Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Crivera C, DeSouza C, Kozma CM, Dirani RD, Mao L, Macfadden W. Resource utilization in patients with schizophrenia who initiated risperidone long-acting therapy: results from the Schizophrenia Outcomes Utilization Relapse and Clinical Evaluation (SOURCE). BMC Psychiatry. 2011 Oct 14;11:168. doi: 10.1186/1471-244X-11-168.
citation: Macfadden W, DeSouza C, Crivera C, Kozma CM, Dirani RD, Mao L, Rodriguez SC. Assessment of effectiveness measures in patients with schizophrenia initiated on risperidone long-acting therapy: the SOURCE study results. BMC Psychiatry. 2011 Oct 14;11:167. doi: 10.1186/1471-244X-11-167.
citation: Lambert T, Olivares JM, Peuskens J, DeSouza C, Kozma CM, Otten P, Crivera C, Jacobs A, Macfadden W, Mao L, Rodriguez SC, Dirani R, Akhras KS. Effectiveness of injectable risperidone long-acting therapy for schizophrenia: data from the US, Spain, Australia, and Belgium. Ann Gen Psychiatry. 2011 Apr 4;10:10. doi: 10.1186/1744-859X-10-10.