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

NCT00246194 | Completed

• 3 other identifiers: CR005035RIS-OUT-173RISSCH4001
• Study Type: observational
• Target: 532
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Keywords

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

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Change from baseline to 24 months in Quality of Life Assessment: Medical Outcomes Survey Short Form (SF-36) scores

  Baseline to 24 months

• Change from baseline to 24 months in patient satisfaction with antipsychotic medication

  Baseline to 24 months

• Change from baseline to 24 months in healthcare resource utilization

  Baseline to 24 months

Study Arms (1)

Patients with schizophrenia

Long-acting injectable of risperidone given as per the prescription from the prescribing physician (Observational study).

Drug: risperidone (RISPERDAL CONSTA)

Interventions

risperidone (RISPERDAL CONSTA) DRUG

Long-acting injectable of risperidone given as per the prescription from the prescribing physician.

Also known as: RISPERDAL CONSTA

Patients with schizophrenia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients diagnosed with schizophrenia

You may qualify if:

• 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

You may not qualify if:

• Use of an investigational drug in the past 30 days
• At risk to self or others

Sponsors & Collaborators

• Janssen, LP: lead

Study Sites (1)

Unknown Facility

Rockville, Maryland, United States

Location

Related Publications (3)

• 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.

  PMID: 21999370 DERIVED

• 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.

  PMID: 21999346 DERIVED

• 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.

  PMID: 21463526 DERIVED

Related Links

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

MeSH Terms

Conditions

Schizophrenia; Mental Disorders; Catatonia

Interventions

Risperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Janssen, LP Clinical Trial

  Janssen, LP

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2005
• First Posted: October 31, 2005
• Study Start: September 1, 2004
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: April 4, 2014

Record last verified: 2014-04

Locations

US (1)