A randomized, double-blind, crossover comparison of risperidone and haloperidol in Korean dementia patients with behavioral disturbances.
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.


CONCLUSIONS
Risperidone had a favorable efficacy and tolerability profile compared with haloperidol in the treatment of BPSD in this patient population.
Suh
Guk-Hee
GH
Department of Psychiatry, Hallym University Medical Center, Hangang Sacred Heart Hospital, 94-200 Yungdungpo-Dong, Seoul 150-030, Korea. suhgh@chollian.net
Son
Hyun Gyun
HG
Ju
Young-Su
YS
Jcho
Kyeong Hyeong
KH
Yeon
Byeong Kil
BK
Shin
Young Min
YM
Kee
Baik Seok
BS
Choi
Sung-Ku
SK
D000368:Aged; D000369:Aged, 80 and over; D014150:Antipsychotic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D018592:Cross-Over Studies; D003704:Dementia / Q000150:complications* / Q000175:diagnosis / Q000208:ethnology*; D004311:Double-Blind Method; D004361:Drug Tolerance; D005260:Female; D006220:Haloperidol / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007723:Korea; D008297:Male; D011595:Psychomotor Agitation / Q000150:complications* / Q000188:drug therapy*; D018967:Risperidone / Q000009:adverse effects / Q000627:therapeutic use*; D011795:Surveys and Questionnaires
D014150:Antipsychotic Agents; D006220:Haloperidol; D018967:Risperidone