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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

532 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-09-30

Study Completion Date

2007-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Schizophrenia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with schizophrenia

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

risperidone (RISPERDAL CONSTA)

Intervention Type DRUG

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

Interventions

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risperidone (RISPERDAL CONSTA)

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

Intervention Type DRUG

Other Intervention Names

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RISPERDAL CONSTA

Eligibility Criteria

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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