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Study of Escitalopram Versus Placebo in the Treatment of Depressive Syndrome in Alzheimer’s Disease, Vascular Dementia, and Mixed Vascular and Alzheimer’s Dementia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00229333
Recruitment Status : Unknown
Verified August 2006 by Sheba Medical Center.
Recruitment status was:  Recruiting
First Posted : September 29, 2005
Last Update Posted : August 29, 2006
H. Lundbeck A/S
Information provided by:
Sheba Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Depressive Syndrome Drug: Escitalopram Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official 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
Study Start Date : December 2004

Primary Outcome Measures :
  1. Cornell Scale for Depression in Dementia (CSDD) total score

Secondary Outcome Measures :
  1. Cohen-Mansfield Agitation Inventory (CMAI; Cohen-Mansfield et al. 1989)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 (Visit 1).
  • 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.

Exclusion Criteria:

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:

  • Schizophrenia
  • 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:

  • Subjects with severe hepatic or renal insufficiency.
  • Hypo/hyperthyroidism
  • B-12 deficiency

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.

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 identifier (NCT number): NCT00229333

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Contact: Anna Sverdlik, MD 972-54-4718424

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Sheba Medical Center Recruiting
Ramat Gan, Israel, 52621
Contact: Anna Sverdlik, MD    972-54-4718424   
Contact: Aviva Cohen, BA    972-3-5305910      
Principal Investigator: Anna Sverdlik, MD         
Sponsors and Collaborators
Sheba Medical Center
H. Lundbeck A/S
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Principal Investigator: Anna Sverdlik, MD Sheba Medical Center

Layout table for additonal information Identifier: NCT00229333    
Other Study ID Numbers: SHEBA-03-3124-AS-CTIL
First Posted: September 29, 2005    Key Record Dates
Last Update Posted: August 29, 2006
Last Verified: August 2006
Keywords provided by Sheba Medical Center:
Depressive Syndrome in Alzheimer’s Disease
Depressive Syndrome in Vascular Dementia
Depressive Syndrome in Mixed Vascular and Alzheimer’s Dementia
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia, Vascular
Vascular Diseases
Depressive Disorder
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cerebrovascular Disorders
Intracranial Arteriosclerosis
Intracranial Arterial Diseases
Arterial Occlusive Diseases
Cardiovascular Diseases
Mood Disorders
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents