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Pharmacopsychiatry 2006; 39(4): 135-141
DOI: 10.1055/s-2006-946703
Original Paper
© Georg Thieme Verlag KG Stuttgart · New York

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
Weitere Informationen

Publikationsverlauf

Received: 12.12.2005 Revised: 27.3.2006

Accepted: 29.3.2006

Publikationsdatum:
27. Juli 2006 (online)

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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.

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