CompletedNot Applicable

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

United States532 participantsStarted 2004-09

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change from baseline to 24 months in Clinical Global Impression of Severity (CGI-S) scores

Timeframe: Baseline (Month 0) to 24 months

Clinical Global Impression of Change (CGI-C) scores during 24 months

Timeframe: 24 months

Change from baseline to 24 months in Global Assessment of Function (GAF) scores

Timeframe: Baseline to 24 months

Change from baseline to 24 months in Personal and Social Performance (PSP) scores

Timeframe: Baseline to 24 months

Change from baseline to 24 months in Strauss-Carpenter Levels of Function (LOF) scores

Timeframe: Baseline to 24 months

Trial details

NCT IDNCT00246194

SponsorJanssen, LP

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2007-11

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