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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen, LP
ClinicalTrials.gov Identifier:
NCT00246194
First received: October 28, 2005
Last updated: April 2, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Schizophrenia
Drug: risperidone (RISPERDAL CONSTA)
Phase 4

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Janssen, LP:

Primary Outcome Measures:
  • Change from baseline to 24 months in Clinical Global Impression of Severity (CGI-S) scores [ Time Frame: Baseline (Month 0) to 24 months ] [ Designated as safety issue: No ]
    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.

  • Clinical Global Impression of Change (CGI-C) scores during 24 months [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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.

  • Change from baseline to 24 months in Global Assessment of Function (GAF) scores [ Time Frame: Baseline to 24 months ] [ Designated as safety issue: No ]
    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).

  • Change from baseline to 24 months in Personal and Social Performance (PSP) scores [ Time Frame: Baseline to 24 months ] [ Designated as safety issue: No ]
    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).

  • Change from baseline to 24 months in Strauss-Carpenter Levels of Function (LOF) scores [ Time Frame: Baseline to 24 months ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • Change from baseline to 24 months in patient satisfaction with antipsychotic medication [ Time Frame: Baseline to 24 months ] [ Designated as safety issue: No ]
    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).

  • Change from baseline to 24 months in healthcare resource utilization [ Time Frame: Baseline to 24 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 532
Study Start Date: September 2004
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00246194

Locations
United States, Maryland
Rockville, Maryland, United States
Sponsors and Collaborators
Janssen, LP
Investigators
Study Director: Janssen, LP Clinical Trial Janssen, LP
  More Information

Additional Information:
No publications provided by Janssen, LP

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Janssen, LP
ClinicalTrials.gov Identifier: NCT00246194     History of Changes
Obsolete Identifiers: NCT01571154
Other Study ID Numbers: CR005035, RIS-OUT-173, RISSCH4001
Study First Received: October 28, 2005
Last Updated: April 2, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Janssen, LP:
Schizophrenia
Mental disorder
DSM-IV
RISPERDAL CONSTA
Risperidone
Long-acting risperidone
Disorganized
Catatonic
Paranoid

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Risperidone
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 23, 2014