Efficacy and tolerability of risperidone, yokukansan, and fluvoxamine for the treatment of behavioral and psychological symptoms of dementia: a blinded, randomized trial.
The descriptive term behavioral and psychological symptoms of dementia (BPSD) is used to cover a range of noncognitive disturbances including anxiety, depression, irritability, aggression, agitation, eating disorders, and inappropriate social or sexual behaviors. Behavioral and psychological symptoms of dementia are seen in about 90% of patients with dementia. We aimed to compare the efficacy and tolerability of risperidone, yokukansan, and fluvoxamine used for BPSD in elderly patients with dementia. Ninety inpatients with dementia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria were investigated in Sato Hospital, Koutokukai. We conducted an 8-week, rater-blinded, randomized trial, administering flexibly dosed risperidone, yokukansan, or fluvoxamine. Primary outcome measures were Neuropsychiatric Inventory in Nursing Home Version total score and its items. Secondary outcome measures were cognitive function measured by Mini-Mental State Examination and daily life function measured by Functional Independence Measure (FIM). Neurological adverse effects were measured by the Drug-Induced Extra-Pyramidal Symptoms Scale. At the end of the study, we analyzed 76 patients (92.7%). Mean Neuropsychiatric Inventory in Nursing Home Version total score decreased in all 3 drug groups, with no significant between-group differences. Mini-Mental State Examination and Functional Independence Measure scores did not change significantly. Drug-Induced Extra-Pyramidal Symptoms Scale scores did not change in the yokukansan and fluvoxamine groups, but increased significantly in the risperidone group. Risperidone, yokukansan, and fluvoxamine were equally effective in the treatment of BPSD in elderly patients. However, yokukansan or fluvoxamine for BPSD showed a more favorable profile in tolerability compared with risperidone. This trial is registered at UMIN Clinical Trials Registry (identifier: UMIN000006146).
Department of Psychiatry and Behavioral Science, Graduate School of Medicine, Nippon Medical School, Bunkyo, Tokyo, Japan.
Mika
M
Teranishi
Masatake
M
Kurita
Satoshi
S
Nishino
Kenji
K
Takeyoshi
Yukio
Y
Numata
Tadahiro
T
Sato
Amane
A
Tateno
Yoshiro
Y
Okubo
D000203:Activities of Daily Living; D000368:Aged; D000369:Aged, 80 and over; D001480:Basal Ganglia Diseases / Q000139:chemically induced; D002491:Central Nervous System Agents / Q000009:adverse effects / Q000627:therapeutic use*; D016009:Chi-Square Distribution; D003704:Dementia / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D004365:Drugs, Chinese Herbal / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D016666:Fluvoxamine / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007564:Japan; D008297:Male; D015999:Multivariate Analysis; D011569:Psychiatric Status Rating Scales; D018967:Risperidone / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome
D002491:Central Nervous System Agents; D004365:Drugs, Chinese Herbal; C524644:Yi-Gan San; D018967:Risperidone; D016666:Fluvoxamine