Escitalopram Treatment of Patients With Agitated Dementia

February 23, 2012 updated by: University of Rochester

Escitalopram in the Treatment of Patients With Agitated Dementia

The purpose of this study is to determine the safety and efficacy of escitalopram (Lexapro) using 10 or 20 mg daily in patients with Alzheimer's disease who are also experiencing agitation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is designed for men and women over 60 who have an established diagnosis of mild to severe Alzheimer's disease and who also present behaviors of agitation such as restlessness, physical aggression, yelling and socially inappropriate interactions. While nonpharmacologic interventions are preferable, many times they are not effective alone. Each consented subject will be enrolled in a 12 week study with escitalopram, 10 or 20 mg per day. Each subject will be evaluated using rating scales designed for symptoms of Alzheimer's and agitated behavior. Each subject will also undergo physical and neurological examinations, laboratory tests and monitoring of side effects of escitalopram.

Study Type

Interventional

Enrollment (Anticipated)

20

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

  • United States
    • New York
      • Fairport, New York, United States, 14450
        • Fairport Baptist Home
      • Rochester, New York, United States, 14642
        • University of Rochester
      • Rochester, New York, United States, 14618
        • The Highlands at Brighton

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

59 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Dementia of Alzheimer's type with behavioral disturbance
  • Mild to severe cognitive impairment
  • Age over 60
  • Medically stable
  • Agitation present both at screening and baseline
  • Agitation not responsive to simple nonpharmacologic interventions and lasting at least 2 weeks prior to enrollment.
  • Available Health Care Proxy or other legal representative to give informed consent, and patient assent.
  • No planned change in environment for duration of study
  • At least one reliable caregiver

Exclusion Criteria:

  • Any intercurrent medical problem that could explain the agitation
  • History of major depression or bipolar preceding the onset of dementia
  • Other major psychiatric illness preceding the onset of dementia or mental retardation
  • Other dementias
  • History of alcohol abuse or dependence in the last 2 years
  • Delirium (or history of delirium in the last 8 weeks)
  • Treatment with other psychotropic drugs except those permitted in the protocol. Patients already treated for agitation with psychotropic medication must be able to successfully discontinue it and tolerate a washout period of no less than 1 week.
  • Treatment with non-psychotropic, centrally active drugs believed to contribute to patient's agitation.
  • Severe psychiatric symptoms requiring psychiatric hospitalization or suicidal, homicidal potential.
  • History of intolerance to citalopram
  • Noncompliance with oral medication or inability to take oral medication
  • Modified Hachinski score of 4 or greater

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Agitation factor on the Neurobehavioral Rating Scale (NBRS)

Secondary Outcome Measures

Outcome Measure
Total NBRS scores
Cohen-Mansfield Agitation Inventory
Neuropsychiatric Inventory
Global Clinical Impression of Change

Collaborators and Investigators

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

Sponsor

University of Rochester

Collaborators

Forest Laboratories

Investigators

  • Principal Investigator: Adrian Leibovici MD, University of Rochester

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

February 1, 2003

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

November 29, 2005

First Submitted That Met QC Criteria

November 29, 2005

First Posted (Estimate)

December 1, 2005

Study Record Updates

Last Update Posted (Estimate)

February 24, 2012

Last Update Submitted That Met QC Criteria

February 23, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LXP MD 43

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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