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Escitalopram Treatment of Patients With Agitated Dementia

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ClinicalTrials.gov Identifier: NCT00260624
Recruitment Status : Completed
First Posted : December 1, 2005
Last Update Posted : February 24, 2012
Forest Laboratories
Information provided by:
University of Rochester

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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Psychomotor Agitation Drug: Escitalopram (Lexapro) Phase 4

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  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Escitalopram in the Treatment of Patients With Agitated Dementia
Study Start Date : February 2003
Primary Completion Date : December 2006
Study Completion Date : December 2006

Primary Outcome Measures :
  1. Agitation factor on the Neurobehavioral Rating Scale (NBRS)

Secondary Outcome Measures :
  1. Total NBRS scores
  2. Cohen-Mansfield Agitation Inventory
  3. Neuropsychiatric Inventory
  4. Global Clinical Impression of Change

Information from the National Library of Medicine

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Ages Eligible for Study:   61 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00260624

United States, New York
Fairport Baptist Home
Fairport, New York, United States, 14450
The Highlands at Brighton
Rochester, New York, United States, 14618
University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Forest Laboratories
Principal Investigator: Adrian Leibovici MD University of Rochester

ClinicalTrials.gov Identifier: NCT00260624     History of Changes
Other Study ID Numbers: LXP MD 43
First Posted: December 1, 2005    Key Record Dates
Last Update Posted: February 24, 2012
Last Verified: February 2012

Keywords provided by University of Rochester:
Alzheimer's Disease

Additional relevant MeSH terms:
Alzheimer Disease
Psychomotor Agitation
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents