| Abstract | BACKGROUND: We report the findings from the first large, double-blind, placebo-controlled study conducted to evaluate the efficacy and safety of risperidone in the treatment of psychotic and behavioral symptoms in institutionalized elderly patients with dementia. METHOD: 625 patients (67.8% women; mean age = 82.7 years) with DSM-IV diagnoses of Alzheimer's disease (73%), vascular dementia (15%), or mixed dementia (12%) and significant psychotic and behavioral symptoms were included. Each patient was randomly assigned to receive placebo or 0.5 mg/day, 1 mg/day, or 2 mg/day of risperidone for 12 weeks. The primary outcome measure was the Behavioral Pathology in Alzheimer's Disease rating scale (BEHAVE-AD). RESULTS: The study was completed by 70% of the patients. Baseline Functional Assessment Staging scores were 6 or 7 in more than 95% of the patients, indicating severe dementia. At endpoint, significantly greater reductions in BEHAVE-AD total scores and psychosis and aggressiveness subscale scores were seen in patients receiving 1 and 2 mg/day of risperidone than in placebo patients (p = .005 and p < .001, respectively). At week 12, 0.5 mg/day of risperidone was superior to placebo in reducing BEHAVE-AD aggression scores (p = .02). More adverse events were reported by patients receiving 2 mg/day of risperidone than 1 mg/day. The most common dose-related adverse events were extrapyramidal symptoms, somnolence, and mild peripheral edema. The frequency of extrapyramidal symptoms in patients receiving 1 mg/day of risperidone was not significantly greater than in placebo patients. CONCLUSION: Risperidone significantly improved symptoms of psychosis and aggressive behavior in patients with severe dementia. Results show that 1 mg/day of risperidone is an appropriate dose for most elderly patients with dementia. |
| Authors | I R Katz, D V Jeste, J E Mintzer, C Clyde, J Napolitano, M Brecher
(Affiliation: Department of Psychiatry, University of Pennsylvania Medical School, Philadelphia 19104, USA. katzi at mail.med.upenn.edu)
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| Journal | The Journal of clinical psychiatry
(J Clin Psychiatry)
Vol. 60
Issue 2
Pg. 107-15
(Feb 1999)
ISSN: 0160-6689 UNITED STATES |
| PMID | 10084637
(Publication Type: Clinical Trial, Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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| Chemical References |
- Antipsychotic Agents
- Placebos
- Risperidone
|
| Topics |
- Aged
- Aged, 80 and over
- Aggression
(drug effects)
- Alzheimer Disease
(drug therapy)
- Antipsychotic Agents
(administration & dosage, adverse effects, therapeutic use)
- Basal Ganglia Diseases
(chemically induced, epidemiology)
- Dementia
(drug therapy, psychology)
- Dementia, Vascular
(drug therapy)
- Dose-Response Relationship, Drug
- Double-Blind Method
- Drug Administration Schedule
- Female
- Geriatric Assessment
- Humans
- Institutionalization
- Male
- Placebos
- Risperidone
(administration & dosage, adverse effects, therapeutic use)
- Severity of Illness Index
- Treatment Outcome
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