A Randomized, Placebo-Controlled Trial of the Discontinuation of Long-Term Antipsychotics in Dementia
|Robert van Reekum a1a3, Diana Clarke a1a2, David Conn a1a3, Nathan Herrmann a3a4, Goran Eryavec a5, Tammy Cohen a1 and Laurie Ostrander a1|
a1 Baycrest Centre for Geriatric Care, Toronto, Canada
a2 Gradute Department of Public Health Sciences, University of Toronto, Toronto, Canada
a3 Division of Geriatric Psychiatry, Department of Psychiatry, University of Toronto, Toronto, Canada
a4 Sunnybrook and Women's College Health Sciences Centre, Toronto Canada
a5 North York General Hospital Toronto, Canada.
The objectives of this randomized clinical trial were to investigate the impact of the discontinuation of long-term antipsychotics in residents with dementia in chronic care institutions and to identify clinical predictors of safe discontinuation. Subjects included 34 residents with dementia who were on antipsychotics for more than 6 months and whose behavior was currently stable. Subjects were randomized to either continue receiving their regular dosage of antipsychotics or to receive placebo for 6 months. Early withdrawal from the study was not statistically different between the groups (relative risk [RR] = 1.57, 95% confidence interval [CI] 0.76–3.26), and though not significantly different, subjects in the placebo group were more likely to be withdrawn from the study because of worsening behavior (RR = 1.25, 95% CI 0.33–4.76). Three subjects in the placebo group were withdrawn from the study due to worsening of extrapyramidal symptoms. The active treatment group had more behavioral problems (e.g., physical aggression towards others, p < .05) compared to the placebo group. The placebo group developed more apathy, but balancing this outcome was a relative improvement in congitive functioning. Baseline antipsychotic dose was predictive of behavioral worsening upon discontinuation of long-term antipsychotic drugs. The primary limitation of the study was the small sample size. In conclusion, a trial of discontinuation of antipsychotics should be considered in this population.
Key Words: Randomized clinical trial; antipsychotics; dementia.