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Clinical Trial Details
Research Study Summary
A clinical trial to evaluate treatments using Escitalopram for patients with Depressive Syndrome
Research Study Title
Exploratory Study to Assess the Efficacy of Escitalopram Versus Placebo in the Treatment of Depressive Syndrome in Alzheimer’s Disease, Vascular Dementia and Mixed Vascular and Alzheimer’s Dementia
The goal of the present study is to compare the effectiveness of the active (S)-enantiomer
of citalopram, escitalopram with placebo in the treatment of patients with depressive
syndrome complicating Alzheimer’s dementia (AD), vascular dementia (VD) or mixed dementia
(MD), for 8 weeks of double-blind treatment.
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Both Male and Female
Both Male and Female ages 60 Years and up
Subject meets criteria for the diagnosis of Alzheimer’s dementia, or vascular
dementia, or mixed alzheimer's and vascular dementia, according to Diagnostic and
Statistical for Mental Disorders, Fourth Edition (DSM-IV) criteria.
Subject meets the following criteria for depressive syndrome: DSM-IV criteria for
major depressive episode; and Cornell Scale of Depression in Dementia is 18 or more.
The depressive syndrome has been present for at least two weeks preceding study entry
The depressive syndrome must be at least moderate in severity at Visit 1 and Visit 2
(cause the subject impairment in functional capacity) and in the opinion of the
investigator require pharmacological intervention.
Score on the Mini Mental State Examination (MMSE) of 10-26 at Visit 1 and at Visit 2.
Other possible reasons for the subject’s depressive symptoms, for example,
medications or other medical conditions (such as pain, infection, cancer of the
pancreas, etc.), have been excluded as an etiology.
General Exclusion Criteria:
Subjects who need placebo run-in period, and/or their caregivers are unable to comply
with Study Period I medication to the extent that drug compliance in the remainder of
the study would be compromised as determined by the investigator.
Investigators, site personnel directly affiliated with this study, and their
immediate families. Immediate family is defined as a spouse, parent, child or
sibling, whether biological or legally adopted.
Diagnostic Exclusion Criteria:
Subjects who are judged clinically to be at serious suicidal risk at Visit 1.
Subjects who have clinically significant psychotic symptoms at Visit 1.
Subject has a serious neurological condition other than AD, VD or MD including, but
not limited to: traumatic (head-brain) dementia, space-occupying lesion, relevant
structural abnormalities on brain imaging, etc.
Subject who underwent CVA for 3 months.
Subject is doing well on a current antidepressant drug regimen.
Exclusionary Concurrent or Historical Illness:
Exclusionary Concomitant or Historical Medications:
Participation in a clinical trial of another investigational drug within 30 days
prior to study entry (Visit 1) and/or any concurrent investigational study.
Subjects with a history of severe adverse reaction to citalopram or escitalopram.
Concomitant medication as specified.
Previous treatment with escitalopram unless, in the opinion of the investigator, the
patient’s previous treatment was inadequate in dose and/or duration to provide an
accurate assessment of the therapy.
Site Locations (1)
||Sheba Medical Center
Anna Sverdlik, MD
Anna Sverdlik, MD
NCT ID: NCT00229333
Date Last Changed: August 28, 2006
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