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

Study Description

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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

Study Design

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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

Arms and Interventions

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Outcome Measures

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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)

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Anna Sverdlik, MD	972-54-4718424	annasver@hotmail.com

Locations

Israel
Sheba Medical Center	Recruiting
Ramat Gan, Israel, 52621
Contact: Anna Sverdlik, MD 972-54-4718424 annasver@hotmail.com
Contact: Aviva Cohen, BA 972-3-5305910
Principal Investigator: Anna Sverdlik, MD

Sponsors and Collaborators

Sheba Medical Center

H. Lundbeck A/S

Investigators

Principal Investigator:	Anna Sverdlik, MD	Sheba Medical Center

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier:	NCT00229333 History of Changes
Other Study ID Numbers:	SHEBA-03-3124-AS-CTIL
First Posted:	September 29, 2005
Last Update Posted:	August 29, 2006
Last Verified:	August 2006

Keywords provided by Sheba Medical Center:

Escitalopram; Depression; Dementia; Treatment	Depressive Syndrome in Alzheimer’s Disease; Depressive Syndrome in Vascular Dementia; Depressive Syndrome in Mixed Vascular and Alzheimer’s Dementia

Additional relevant MeSH terms:

Syndrome; Alzheimer Disease; Dementia; Dementia, Vascular; Depressive Disorder; Vascular Diseases; Disease; Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders	Cerebrovascular Disorders; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Cardiovascular Diseases; Mood Disorders; Citalopram; Dexetimide; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents