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BMC Psychiatry
Published in: BMC Psychiatry 1/2011

Open Access 01-12-2011 | Research article

Assessment of effectiveness measures in patients with schizophrenia initiated on risperidone long-acting therapy: the SOURCE study results

Authors: Wayne Macfadden, Cherilyn DeSouza, Concetta Crivera, Chris M Kozma, Riad D Dirani, Lian Mao, Stephen C Rodriguez

Published in: BMC Psychiatry | Issue 1/2011

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Abstract

Background

To evaluate effectiveness outcomes in a real-world setting in patients with schizophrenia initiating risperidone long-acting therapy (RLAT).

Methods

This was a 24-month, multicenter, prospective, longitudinal, observational study in patients with schizophrenia who were initiated on RLAT. Physicians could change treatment during the study as clinically warranted. Data were collected at baseline and subsequently every 3 months up to 24 months. Effectiveness outcomes included changes in illness severity as measured by Clinical Global Impression-Severity (CGI-S) scale; functional scores as measured by Personal and Social Performance (PSP) scale, Global Assessment of Functioning (GAF), and Strauss-Carpenter Levels of Functioning (LOF); and health status (Medical Outcomes Survey Short Form-36 [SF-36]). Life-table methodology was used to estimate the cumulative probability of relapse over time. Adverse events were evaluated for safety.

Results

532 patients were enrolled in the study; 209 (39.3%) completed the 24-month study and 305 (57.3%) had at least 12 months of follow-up data. The mean (SD) age of patients was 42.3 (12.8) years. Most patients were male (66.4%) and either Caucasian (60.3%) or African American (23.7%). All changes in CGI-S from baseline at each subsequent 3-month follow-up visit were statistically significant (p < .0001), indicating improvement in disease severity. Improvements were also noted for the PSP, GAF, and total LOF, indicating improvement in daily functioning and health outcome.

Conclusions

Patients with schizophrenia who were initiated on RLAT demonstrated improvements in measures of effectiveness within 3 months, which persisted over 24 months.

Trial Registration

ClinicalTrials.gov: NCT00246194
Appendix
Available only for authorised users
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Metadata
Title
Assessment of effectiveness measures in patients with schizophrenia initiated on risperidone long-acting therapy: the SOURCE study results
Authors
Wayne Macfadden
Cherilyn DeSouza
Concetta Crivera
Chris M Kozma
Riad D Dirani
Lian Mao
Stephen C Rodriguez
Publication date
01-12-2011
Publisher
BioMed Central
Published in
BMC Psychiatry / Issue 1/2011
Electronic ISSN: 1471-244X
DOI
https://doi.org/10.1186/1471-244X-11-167

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