Abstract
Objectives: To evaluate the clinical efficacy and safety of shifting from the oral to the long-acting depot form of risperidone. Methods: We recruited 21 schizophrenic patients who were stable on oral risperidone for at least 9 weeks for participation in this 12-week, non-randomized, single arm, open study. Clinical efficacy and safety were evaluated with the Positive and Negative Syndrome Scale (PANSS), the Clinical Global Impression scale (CGI) and the Extrapyramidal Syndrome Rating Scale (ESRS) a the start of trial and at the 2nd, 4(superscript th), 8(superscript th) and 12(superscript th) weeks. Results: Switching from oral to depot risperidone did not result in significant changes in PANSS total score, positive subscale, general psychopathology sub- scale and CGI scores, while the PANSS negative subscale score showed significant reduction. Significant clinical global improvement, as defined by a reduction in PANSS total score of greater than 20%, was found in 14.3% of patients. None of the patients showed significant deterioration in clinical condition defined by a worsening of PANS S total score ＞ 20% or a change in CGI of more than 2 points. The severity of EPS decreased significantly, especially for parkinsonism symptoms. Although various side effects were reported, most were nonspecific subjective complaints carried over from the previous period of oral risperidone treatment. No significant change in QTc or mean body weight was from baseline to the study endpoint. Conclusion: This study showed that depot risperidone was as effective as oral Risperidone in maintenance therapy for schizophrenia, and had a comparable side effect profile. A controlled prospective study with a larger sample size, however, is needed to confirm these findings.
Published Version
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