A Comparative Efficacy and Safety Study of Long-Acting Risperidone Injection and Risperidone Oral Tablets Among Hospitalized Patients: 12-Week Randomized, Single-Blind Study

Y. M. Bai; T. T. Chen; B. Wu; C. H. Hung; W. K. Lin; T. M. Hu; C.-Y. Lin; P. Chou

doi:10.1055/s-2006-946703

Pharmacopsychiatry 2006; 39(4): 135-141
DOI: 10.1055/s-2006-946703

Original Paper

A Comparative Efficacy and Safety Study of Long-Acting Risperidone Injection and Risperidone Oral Tablets Among Hospitalized Patients: 12-Week Randomized, Single-Blind Study

Y. M. Bai¹ ^, ² ^, ³ ^, ⁴ , T. T. Chen³ ^, ⁵ , B. Wu³ ^, ⁶ , C. H. Hung³ , W. K. Lin³ , T. M. Hu⁷ , C.-Y. Lin³ , P. Chou¹

¹Institute of Public Health, National Yang-Ming University, Taiwan
²Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan
³Department of Psychiatry, Yu-Li Veterans Hospital, Taiwan
⁴Department of Psychiatry, National Yang-Ming University, Taipei, Taiwan
⁵Graduate Institute of Behavior Sciences, Kaohsiung Medical University, Taiwan
⁶Graduate of Epidemiology, College of Public Health, National Taiwan University, Taiwan
⁷Department of Psychiatry, Yu-Li Hospital, Taiwan

Abstract

Objective: The superiority of risperidone long-acting injection (RLAI) over oral typical and atypical antipsychotics demonstrated in previous studies may be related to the improved drug compliance. The aim of the 12-week randomized, single-blind study was to test whether the superiority of RLAI remained among hospitalized patients that drug compliance could be optimally controlled. Methods: Fifty hospitalized stable schizophrenic patients, who had maintained on oral risperidone for more than 3 months, were randomized to the RLAI and oral risperidone group. Finally 49 patients (98 %) completed the study, and no dose change of oral risperidone, or RLAI was noted among all patients. Results: The RLAI group showed significantly increased positive score of Positive and Negative Syndrome Scale (PANSS) than the risperidone group (0.72 ± 3.52 vs. –1.24 ± 3.81, p = 0.022), but without significance difference for the PANSS total, negative and general psychopathology scores. The RLAI group also showed a significantly improved Udvalg for Kliniske Undersogelser (UKU) Scale (p = 0.037), social life domains of Short-From Health Survey (SF-36) (p = 0.011), and reduced prolactin level (p = 0.001). Conclusion: The results indicated that with optimal controlling of drug compliance among hospitalized patients, RLAI showed no benefit of efficacy over oral risperidone, but with advantages of improved side-effect profiles, social life ratings, and reduced prolactin levels.

Full Text

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Pesus Chou Dr. P. H.

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