NCT01119638

Escitalopram Treatment for BPSD in Alzheimer's Disease in Comparison to Risperidone

Post Marketing Study of Escitalopram Versus Risperidone for the Treatment of Behavioral and Psychological Symptoms Amongst Alzheimer's Disease Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Abarbanel Mental Health Center · Other Government
• Sex: All
• Age: 55 Years – 95 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Agitation
• Psychosis
• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	Escitalopram	Patients in the escitalopram group will receive 5 mgs/d for the first week and than 10 mgs/d till completion.
DRUG	Risperidone	Patients in the risperidone group will receive 0.5 mgs/d for the first week and than 1.0 mg/d till completion.

Timeline

• Start date: 2008-04-01
• Primary completion: 2010-04-01
• Completion: 2010-05-01
• First posted: 2010-05-07
• Last updated: 2015-06-24

Locations

1 site across 1 country: Israel