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

June 23, 2015 updated by: Yoram Barak, Abarbanel Mental Health Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Bat-Yam, Israel, 59100
        • Abarbanel MHC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

53 years to 93 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Eligible participants will fulfill criteria for dementia of the Alzheimer's type (according to the Diagnostic and Statistical Manual of Mental Disorders, fourth edition). The score on the Mini-Mental State Examination (MMSE) has to be between 5 and 26.

Eligible patients will suffer from delusions, hallucinations, aggression, or agitation that developed after the onset of dementia and is severe enough to disrupt their functioning and, in the opinion of the study physicians, to justify treatment with antipsychotic drugs.

Signs and symptoms of psychosis, aggression, or agitation will have to occur nearly daily during the week prior to enrollment.

A frequency rating of "often" or "more frequently" and a severity rating of at least "moderate" are required for delusions, hallucinations, agitation, or "aberrant motor behavior" in the Neuropsychiatric Inventory (NPI).

Exclusion Criteria:

Patients will be excluded if they had received a diagnosis of a primary psychotic disorder (e.g., schizophrenia), delirium, other dementia. Patients will also be excluded if they were going to receive treatment with a cholinesterase inhibitor or antidepressant medication, had previously been treated with escitalopram for BPSD, or had contraindications to the two study drugs.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Escitalopram Drug

Drug:

Patients in the escitalopram group will receive 5 mgs/d for the first week and than 10 mgs/d till completion.
Drug: Escitalopram
Patients in the escitalopram group will receive 5 mgs/d for the first week and than 10 mgs/d till completion.
Other Names:
  • Cipralex
Active Comparator: Risperidone Drug
Patients in the risperidone group will receive 0.5 mgs/d for the first week and than 1.0 mg/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.
Other Names:
  • Risperdal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in total score on the NPI.
Time Frame: from first treatment to end of study at 6 weeks
from first treatment to end of study at 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time from initial treatment to the discontinuation of treatment for any reason.
Time Frame: time to discontinuation 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 to discontinuation for any reason

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abarbanel Mental Health Center

Investigators

  • Principal Investigator: Yoram Barak, MD, MHA, Abarbanel MHC, Israel.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

May 6, 2010

First Submitted That Met QC Criteria

May 6, 2010

First Posted (Estimate)

May 7, 2010

Study Record Updates

Last Update Posted (Estimate)

June 24, 2015

Last Update Submitted That Met QC Criteria

June 23, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABR-BPSD-001
  • CO01ABR01022008 (Other Grant/Funding Number: Lundbeck A/S)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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