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

NCT01119638 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2015-06-24

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Abarbanel Mental Health Center

    lead OTHER_GOV

Principal Investigators

  • Yoram Barak, MD, MHA · Abarbanel MHC, Israel.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2010-04-30
Completion
2010-05-31

Countries

  • Israel

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01119638 on ClinicalTrials.gov