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A Randomized, Double-Blind, Crossover Comparison of Risperidone and Haloperidol in Korean Dementia Patients With Behavioral Disturbances

Received October 18, 2002; revised March 13, May 22, 2003; accepted June 17, 2003. From the Department of Psychiatry, Hallym University Medical Center, Hangang Sacred Heart Hospital, Seoul, Korea (GHS,HGS), the Department of Occupational & Environmental Medicine, Hallym University Sacred Heart Hospital, Seoul, Korea (YSJ), the Department of Psychiatry, Kangnam Hospital Public Corporation, Seoul, Korea (KHJ,YMS), the Department of Psychiatry, Hallym University Medical Center, Kangdong Sacred Heart Hospital, Seoul, Korea (BKY), the Department of Psychiatry, Pil Dong Hospital, Chung Ang University, College of Medicine, Seoul, Korea (BSK), and the Medical Department, Janssen Korea, Seoul, Korea (SKC). Send correspondence to Associate Professor Guk-Hee Suh, Department of Psychiatry, Hallym University Medical Center, Hangang Sacred Heart Hospital, 94-200 Yungdungpo-Dong, Seoul 150-030, Korea. e-mail: suhgh{at}chollian.net
© 2004 American Association for Geriatric Psychiatry

Objective: Behavioral disturbances in dementia are extremely prominent and distressful, and often result in serious physical, social, and economic consequences. The authors compared the efficacy and tolerability of risperidone and haloperidol in the treatment of behavioral and psychological symptoms of dementia (BPSD) in institutionalized elderly Korean patients with Alzheimer disease, vascular dementia, or mixed dementia. Methods: This was an 18-week double-blind, crossover study involving 120 patients who were randomly assigned to receive flexible doses (0.5–1.5 mg/day) of risperidone or haloperidol. BPSD were assessed using the Korean version of the Behavioral Pathology in Alzheimer's Disease Rating Scale (BEHAVE-AD-K), the Korean version of the Cohen-Mansfield Agitation Inventory (CMAI-K), and the Clinical Global Impression of Change scale (CGI-C). Safety and tolerability assessments included the Extrapyramidal Symptom Rating Scale and the incidence of adverse events. Results: Both risperidone and haloperidol were efficacious in alleviating BPSD. However, when receiving risperidone, patients showed significantly greater improvement than when receiving haloperidol in the total and subscale scores of the BEHAVE-AD-K, the total and subscale scores of the CMAI-K, and the scores on the CGI-C scale. Also, risperidone had an additional benefit on aggressiveness and anxieties/phobias. The risk of antipsychotic-induced parkinsonism throughout this study was significantly lower with risperidone than with haloperidol. Conclusion: Risperidone had a favorable efficacy and tolerability profile compared with haloperidol in the treatment of BPSD in this patient population.

Key Words: Dementia • Risperidone • Haloperidol • Cross-Cultural Studies

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