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Escitalopram Treatment of Patients With Agitated Dementia

Primary Purpose

Alzheimer's Disease, Psychomotor Agitation

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Escitalopram (Lexapro)
Sponsored by
University of Rochester
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring agitation, dementia, Alzheimer's Disease

Eligibility Criteria

61 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fairport Baptist Home
  • The Highlands at Brighton
  • University of Rochester

Outcomes

Primary Outcome Measures

Agitation factor on the Neurobehavioral Rating Scale (NBRS)

Secondary Outcome Measures

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

Full Information

First Posted
November 29, 2005
Last Updated
February 23, 2012
Sponsor
University of Rochester
Collaborators
Forest Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT00260624
Brief Title
Escitalopram Treatment of Patients With Agitated Dementia
Official Title
Escitalopram in the Treatment of Patients With Agitated Dementia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Rochester
Collaborators
Forest Laboratories

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease, Psychomotor Agitation
Keywords
agitation, dementia, Alzheimer's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Escitalopram (Lexapro)
Primary Outcome Measure Information:
Title
Agitation factor on the Neurobehavioral Rating Scale (NBRS)
Secondary Outcome Measure Information:
Title
Total NBRS scores
Title
Cohen-Mansfield Agitation Inventory
Title
Neuropsychiatric Inventory
Title
Global Clinical Impression of Change

10. Eligibility

Sex
All
Minimum Age & Unit of Time
61 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adrian Leibovici MD
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fairport Baptist Home
City
Fairport
State/Province
New York
ZIP/Postal Code
14450
Country
United States
Facility Name
The Highlands at Brighton
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States

12. IPD Sharing Statement

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Escitalopram Treatment of Patients With Agitated Dementia

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