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Efficacy and tolerability of risperidone, yokukansan, and fluvoxamine for the treatment of behavioral and psychological symptoms of dementia: a blinded, randomized trial


Teranishi, Mika, Kurita, Masatake, Nishino, Satoshi, Takeyoshi, Kenji, Numata, Yukio, Sato, Tadahiro, Tateno, Amane, Okubo, Yoshiro


Journal Of Clinical Psychopharmacology, Volume: 33, No.: 5, Pages.: 600-607

Year of Publication



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). ;

Bibtex Citation

@article{Teranishi_2013, doi = {10.1097/jcp.0b013e31829798d5}, url = {}, year = 2013, month = {oct}, publisher = {Ovid Technologies (Wolters Kluwer Health)}, volume = {33}, number = {5}, pages = {600--607}, author = {Mika Teranishi and Masatake Kurita and Satoshi Nishino and Kenji Takeyoshi and Yukio Numata and Tadahiro Sato and Amane Tateno and Yoshiro Okubo}, title = {Efficacy and Tolerability of Risperidone, Yokukansan, and Fluvoxamine for the Treatment of Behavioral and Psychological Symptoms of Dementia}, journal = {Journal of Clinical Psychopharmacology} }


activities of daily living, adverse effects, aged, aged, 80 and over, basal ganglia diseases, central nervous system agents, chemically induced, dementia, diagnosis, drug therapy, drugs chinese herbal, female, fluvoxamine, humans, japan, male, multivariate analysis, psychiatric status rating scales, psychology, risperidone, therapeutic use, time factors, treatment outcome, yokukansan

Countries of Study


Types of Dementia

Dementia (general / unspecified)

Types of Study

Randomised Controlled Trial

Type of Outcomes

ADLs/IADLs, Behaviour, Cognition


Hospital Inpatient Care

Type of Interventions

Pharmaceutical Interventions

Pharmaceutical Interventions

Antipsychotics and antidepressants, Herbal remedies, vitamins, dietary supplements