title: Comparison of olanzapine and risperidone in the treatment of psychosis and associated behavioral disturbances in patients with dementia.
abstract: OBJECTIVE
  The authors compared efficacy of olanzapine versus placebo and risperidone as measured by the Neuropsychiatric Inventory and Clinical Global Impression-Severity of Psychosis scale in patients with dementia-related psychosis.
  
  
  METHODS
  Patients with moderate-to-severe psychotic symptoms associated with dementia were recruited from outpatient or residential settings and randomly assigned to 10-week, double-blind, flexible-dose treatment with olanzapine (N=204; 2.5 mg-10 mg/day; mean: 5.2 mg/day), risperidone (N=196; 0.5 mg-2 mg/day; mean: 1.0 mg/day) or placebo (N=94).
  
  
  RESULTS
  Most measures of neuropsychiatric functioning improved in all treatment groups, including the placebo group, and no significant treatment differences occurred. Overall discontinuation was lowest in the placebo group, and the olanzapine group had a significantly higher incidence of discontinuation due to adverse events (16.2%) relative to placebo (3.2%) and risperidone (8.7%) groups. Treatment-emergent extrapyramidal symptoms were more numerous for risperidone- than placebo- or olanzapine-treated patients. Abnormally high prolactin levels occurred in 78.0% of risperidone patients, compared with 16.7% for olanzapine and 5.0% for placebo. The incidence of weight gain greater than 7% from baseline was higher in the olanzapine group relative to risperidone, but neither active-treatment group showed a statistical difference from placebo (1.1%). No other statistically significant and clinically relevant differences were seen for any other vital sign, electrocardiographic measure, or laboratory hematology and chemistry, including glucose, except for cholesterol, which decreased from baseline to endpoint in both active-treatment groups.
  
  
  CONCLUSIONS
  Patients' neuropsychiatric functioning improved with olanzapine, risperidone, and placebo treatment. There was a substantial response in the placebo group, and no significant differences emerged among treatments.
authors.affiliation: Lilly Research Laboratories, Indianapolis, IN, USA. deberdt_walter@lilly.com
authors.forename: Walter G
authors.initials: WG
authors.lastname: Deberdt
authors.forename: Maurice W
authors.initials: MW
authors.lastname: Dysken
authors.forename: Stephen A
authors.initials: SA
authors.lastname: Rappaport
authors.forename: Peter D
authors.initials: PD
authors.lastname: Feldman
authors.forename: Carrie A
authors.initials: CA
authors.lastname: Young
authors.forename: Donald P
authors.initials: DP
authors.lastname: Hay
authors.forename: Deborah L
authors.initials: DL
authors.lastname: Lehman
authors.forename: Martin
authors.initials: M
authors.lastname: Dossenbach
authors.forename: Elisabeth K
authors.initials: EK
authors.lastname: Degenhardt
authors.forename: Alan
authors.initials: A
authors.lastname: Breier
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000544:Alzheimer Disease / Q000188:drug therapy* / Q000523:psychology; D014150:Antipsychotic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001480:Basal Ganglia Diseases / Q000139:chemically induced; D001569:Benzodiazepines / Q000009:adverse effects / Q000627:therapeutic use; D010054:Brief Psychiatric Rating Scale; D015897:Comorbidity; D019955:Conduct Disorder / Q000188:drug therapy* / Q000523:psychology; D015140:Dementia, Vascular / Q000188:drug therapy* / Q000523:psychology; D003865:Major Depressive Disorder / Q000188:drug therapy* / Q000523:psychology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D009483:Neuropsychological Tests; D000077152:Olanzapine; D011595:Psychomotor Agitation / Q000188:drug therapy / Q000523:psychology; D018967:Risperidone / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D014150:Antipsychotic Agents; D001569:Benzodiazepines; D018967:Risperidone; D000077152:Olanzapine