Observational Study in Patients With Schizophrenia Treated With Long-Acting Risperidone Injection (RISPERDAL CONSTA) (SOURCE)

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)

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: risperidone (RISPERDAL CONSTA)

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.

• Study Type: Observational
• Enrollment (Actual): 532

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Rockville, Maryland, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients diagnosed with schizophrenia

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with schizophrenia; Long-acting injectable of risperidone given as per the prescription from the prescribing physician (Observational study).	Drug: risperidone (RISPERDAL CONSTA); Long-acting injectable of risperidone given as per the prescription from the prescribing physician.; Other Names: RISPERDAL CONSTA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline to 24 months in Clinical Global Impression of Severity (CGI-S) scores	The CGI-S is a 7-point scale ranging from 1 to 7 (normal, not at all ill to among the most severely ill patients), which measures disease severity in psychiatric patients. The scale is completed by physician.	Baseline (Month 0) to 24 months
Clinical Global Impression of Change (CGI-C) scores during 24 months	The CGI-C is a 7-point scale ranging from 1 to 7 (very much improved to very much worse), which is used to rate the change in the patient's illness compared to baseline. The scale assesses the patient's improvement over time. The scale is completed by physician.	24 months
Change from baseline to 24 months in Global Assessment of Function (GAF) scores	GAF is completed by the physician. GAF is a single item rating of the patient's psychological, social, and occupational functioning on a hypothetical continuum of mental health-illness. Respondents are asked to rate the subject's lowest level of functioning in the last week. GAF scores range from 0 to 100. (0 = Inadequate information, 1 = Persistent danger of severely hurting self or others and 100 = Superior functioning in a wide range of activities).	Baseline to 24 months
Change from baseline to 24 months in Personal and Social Performance (PSP) scores	The PSP Scale is completed by the physician. PSP is a rating of a patient's level of functioning during the past month in 4 areas: (a) socially useful activities (including work and study); (b) personal and social relationships; (c) self-care; and (d) disturbing and aggressive behaviors. Scores range from 1 to 100. (1= Lack of autonomy in basic functioning and 100 = Excellent functioning in all 4 main areas).	Baseline to 24 months
Change from baseline to 24 months in Strauss-Carpenter Levels of Function (LOF) scores	The Strauss-Carpenter LOF is completed by the physician. It consists of 9 items that can be grouped into 4 subscales: symptoms (absence of symptoms and recent hospitalizations), social contacts (frequency and quality of social contacts), work (quantity and quality of useful work), and function (ability to meet basic needs, fullness of life, and overall level of function). Each item is rated on a scale of 0 (worst functioning) to 4 (best functioning).	Baseline to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline to 24 months in Quality of Life Assessment: Medical Outcomes Survey Short Form (SF-36) scores	Patients completed the SF-36. The survey includes 36 items and evaluates health status in the past 4 weeks, in 8 different areas, which can be broadly summarized as physical health (physical functioning [PF], role-physical [RP], bodily pain [BP] and general health [GH]) and mental health (vitality [VT], social functioning [SF], role-emotional [RE], and mental health [MH]). In addition, the SF-36 evaluates health status in 2 broadly-defined areas, mental health and physical health. Higher scores represent better health status.	Baseline to 24 months
Change from baseline to 24 months in patient satisfaction with antipsychotic medication	Patients are asked a single question to evaluate patient satisfaction with their current Anti psychotic medication. The question is, "The way I feel about my current antipsychotic is:" and used a 7-point response scale from 1 to 7 (extremely dissatisfied to extremely satisfy).	Baseline to 24 months
Change from baseline to 24 months in healthcare resource utilization	Healthcare resource utilization including dates of hospitalizations (inpatient), emergency room (ER) visits, and outpatient visits, consultations with specialists and general practitioners. Relapse rates (from psychiatric hospitalizations, suicidal behavior or homicidal behavior) are also captured as resource utilization.	Baseline to 24 months

Collaborators and Investigators

• Sponsor: Janssen, LP

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Helpful Links

• The SOURCE Study: Schizophrenia Outcomes-Utilization, Relapse, and Clinical Evaluation

Study record dates

Study Major Dates

• Study Start: September 1, 2004
• Primary Completion (Actual): November 1, 2007
• Study Completion (Actual): November 1, 2007

Study Registration Dates

• First Submitted: October 28, 2005
• First Submitted That Met QC Criteria: October 28, 2005
• First Posted (Estimate): October 30, 2005

Study Record Updates

• Last Update Posted (Estimate): April 4, 2014
• Last Update Submitted That Met QC Criteria: April 2, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Schizophrenia; Risperidone; Mental disorder; Long-acting risperidone; Disorganized; DSM-IV; Paranoid; RISPERDAL CONSTA; Catatonic
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Dopamine Agents; Serotonin Antagonists; Dopamine Antagonists; Risperidone
• Other Study ID Numbers: CR005035; RIS-OUT-173 (Other Identifier: Janssen, LP); RISSCH4001 (Other Identifier: Janssen, LP)