Behavioral and psychological symptoms of dementia (BPSD) are among the most distressing manifestations of dementia. Pharmacotherapy is frequently used and especially in institutional settings. Current guidelines recommend the use of second-generation antipsychotics (SGAs). Nonetheless, there are concerns regarding both their safety and effectiveness in patients with dementia. Inconclusive evidence support the use of other psychoactive agents such as SSRI antidepressants or cognitive enhancers. In two published studies citalopram was as efficacious as, but better tolerated than perphenazine or risperidone in patients with BPSD. Thus, with proven efficacy and a beneficial safety profile the evaluation of the use of escitalopram for BPSD is warranted.
Behavioral and psychological symptoms of dementia (BPSD) as agitation or psychosis are among the most distressing manifestations of dementia. The evidence-based management of these symptoms includes the search for treatable physical and environmental precipitants, support and psychoeducation for primary caregivers and psychosocial interventions. Nevertheless, pharmacotherapy is frequently used and especially in institutional settings. Current guidelines recommend the use of second-generation antipsychotics (SGAs). Nonetheless, there are concerns regarding both their safety and effectiveness in patients with dementia. Recent research has resulted in a 'black-box" warning concerning the safety of using SGAs for BPSD. Sparse and inconclusive evidence support the use of other psychoactive agents such as SSRI antidepressants or cognitive enhancers. In two published randomized controlled trials, citalopram was more efficacious than placebo and as efficacious as, but better tolerated than perphenazine or risperidone in patients with dementia hospitalized for the treatment of agitation or psychosis. Thus, with proven efficacy and a beneficial safety profile the evaluation of the use of escitalopram for BPSD is warranted. A 6-week parallel groups, randomized, controlled trial in patients with dementia hospitalized because of behavioral symptoms will be conducted at the Abarbanel MHC. Participants will be consecutively recruited on an inpatient unit. Randomization will be based on a table of random numbers held centrally by an uninvolved physician. The study will be of a "double-blind" design. All medications in identical packaging will be distributed to the ward from a central pharmacy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
Patients in the escitalopram group will receive 5 mgs/d for the first week and than 10 mgs/d till completion.
Patients in the risperidone group will receive 0.5 mgs/d for the first week and than 1.0 mg/d till completion.
Abarbanel MHC
Bat Yam, Israel
Change in total score on the NPI.
Time frame: from first treatment to end of study at 6 weeks
Time from initial treatment to the discontinuation of treatment for any reason.
we shall consider any reason for stopping the study medications to be avalid reason for "discontinuation. This measure was deemed important by the NIH for dementia drug studies.
Time frame: time to discontinuation for any reason
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