Escitalopram Treatment for BPSD in Alzheimer's Disease in Comparison to Risperidone
Condition: Agitation; Psychosis; Alzheimer's Disease
MeSH terms: Alzheimer Disease; Psychomotor Agitation; Psychotic Disorders; Mental Disorders
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Escitalopram; Risperidone
Intervention type(s): Drug; Drug
Intervention description(s): 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.
Other intervention name(s): Cipralex; Risperdal
Intervention MeSH terms: Risperidone; Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alzheimer's disease; BPSD; escitalopram; Risperidone; Agitation; Psychosis; Dementia; Elderly