Efficacy and Safety of Aripiprazole in the Treatment of by l990juh


									     Efficacy and Safety of Aripiprazole in the Treatment of
        Acutely Relapsed Patients with Schizophrenia or
     Schizoaffective Disorder with Risperidone as an Active

Hung-Yu Chan1, M.D.; Wei-Wen Lin2, M.D., Ph.D.; Shih-Ku Lin3, M.D.;
Tzung-Jeng Hwang*4, M.D., M.P.H.; Tung-Ping T. Su5, M.D.; Shu-Chuan
           Chiang6, M.D., M.S.; and Hai-Gwo Hwu4, M.D.


Background: Aripiprazole is a dopamine receptor partial agonist which has
demonstrated robust efficacy and a favorable safety profile in previously performed
western-world clinical trials. However, studies of aripiprazole in Asian and Chinese
populations are limited. This multi-center study in Taiwan examined the efficacy,
safety, and tolerability of aripiprazole in Chinese schizophrenia or schizoaffective
patients with acute relapse of psychotic symptoms. Methods: This is a multi-center
4-week, double-blind, randomized, parallel study comparing the efficacy and safety of
15 mg/d aripiprazole (n=49) and 6 mg/d risperidone (n=34). Efficacy measures
includedPositive and Negative Syndrome Scale (PANSS) total, PANSS positive,
PANSS negative, Clinical Global Impression (CGI)-Severity of Illness and
CGI-Improvement. Extrapyramidal symptoms (EPS), weight gain, serum prolactin
level, corrected QT interval and self report adverse events were assess as a measure of
safety and tolerability.Results: Both aripiprazole and risperidone showed statistical
improvement from baseline in PANSS total, PANSS positive, PANSS negative,
CGI-Severity scores at study endpoint. Significant improvement was noted in the first
week of treatment for both treatment groups. There were no significant differences in
efficacy measures between treatment groups. Aripiprazole showed less EPS liability
assessed by Simpson-Angus Scale and less serum prolactin level elevation than
risperidone. Both groups showed mild body weight gain. No patients showed
clinically significant QTc interval prolongation in this study. Conclusion:
Aripiprazole is an effective antipsychotic agent in short-term treatment for Chinese
patients with acute schizophrenia. Compared to risperidone 6 mg/d, aripiprazole 15
mg/d has comparable efficacy and favorable safety and tolerability profile.
 Taoyuan Mental Hospital, Taoyuan County, Taiwan and Institute of Preventive Medicine, College of
Public Health, National Taiwan University, Taipei, Taiwan; 2 Tri-Service General Hospital, Taipei,
Taiwan; 3 Taipei City Psychiatric Center, Taipei, Taiwan; 4 National Taiwan University Hospital, Taipei,
Taiwan; 5 Veterans General Hospital, Taipei, Taiwan; 6 Taoyuan Mental Hospital, Taoyuan County,

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