Escitalopram Treatment of Patients With Agitated Dementia
Completed · Phase 4
Conditions studied: Alzheimer's Disease, Psychomotor Agitation
In brief
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.
Key facts
- Study ID
- NCT00260624
- Run by
- University of Rochester
- People needed
- 20
- Starts
- 2003-02-01
- Expected to finish
- 2006-12-01
- Last updated by the study team
- 2012-02-24
Who can join
Age: 61 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Fairport Baptist Home — Fairport, New York, United States
- The Highlands at Brighton — Rochester, New York, United States
- University of Rochester — Rochester, New York, United States
Full record on ClinicalTrials.gov
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