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

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment
Schizophrenia	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 Design

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Study Type :	Observational
Actual Enrollment :	532 participants
Observational Model:	Cohort
Time Perspective:	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)
Study Start Date :	September 2004
Actual Primary Completion Date :	November 2007
Actual Study Completion Date :	November 2007

Groups and Cohorts

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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 Name: RISPERDAL CONSTA

Outcome Measures

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Primary Outcome Measures :

1. Change from baseline to 24 months in Clinical Global Impression of Severity (CGI-S) scores [ Time Frame: Baseline (Month 0) to 24 months ]
   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.
2. Clinical Global Impression of Change (CGI-C) scores during 24 months [ Time Frame: 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.
3. Change from baseline to 24 months in Global Assessment of Function (GAF) scores [ Time Frame: Baseline to 24 months ]
   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).
4. Change from baseline to 24 months in Personal and Social Performance (PSP) scores [ Time Frame: Baseline to 24 months ]
   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).
5. Change from baseline to 24 months in Strauss-Carpenter Levels of Function (LOF) scores [ Time Frame: Baseline to 24 months ]
   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).

Secondary Outcome Measures :

1. Change from baseline to 24 months in Quality of Life Assessment: Medical Outcomes Survey Short Form (SF-36) scores [ Time Frame: Baseline to 24 months ]
   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.
2. Change from baseline to 24 months in patient satisfaction with antipsychotic medication [ Time Frame: Baseline to 24 months ]
   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).
3. Change from baseline to 24 months in healthcare resource utilization [ Time Frame: Baseline to 24 months ]
   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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Adult patients diagnosed with schizophrenia

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

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Maryland
Rockville, Maryland, United States

Sponsors and Collaborators

Janssen, LP

Investigators

Study Director:	Janssen, LP Clinical Trial	Janssen, LP

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Janssen, LP
ClinicalTrials.gov Identifier:	NCT00246194 History of Changes
Obsolete Identifiers:	NCT01571154
Other Study ID Numbers:	CR005035; RIS-OUT-173 ( Other Identifier: Janssen, LP ); RISSCH4001 ( Other Identifier: Janssen, LP )
First Posted:	October 31, 2005
Last Update Posted:	April 4, 2014
Last Verified:	April 2014

Keywords provided by Janssen, LP:

Schizophrenia; Mental disorder; DSM-IV; RISPERDAL CONSTA; Risperidone	Long-acting risperidone; Disorganized; Catatonic; Paranoid

Additional relevant MeSH terms:

Schizophrenia; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Risperidone; Serotonin Antagonists; Serotonin Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action	Physiological Effects of Drugs; Antipsychotic Agents; Tranquilizing Agents; Central Nervous System Depressants; Psychotropic Drugs; Dopamine Antagonists; Dopamine Agents