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. |
ClinicalTrials.gov 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
|
- Study Details
- Tabular View
- Results Submitted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Depressive Syndrome | Drug: Escitalopram | Phase 4 |
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 |

- Cornell Scale for Depression in Dementia (CSDD) total score
- Cohen-Mansfield Agitation Inventory (CMAI; Cohen-Mansfield et al. 1989)

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.
Ages Eligible for Study: | 60 Years and older (Adult, Senior) |
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.

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): NCT00229333
Contact: Anna Sverdlik, MD | 972-54-4718424 | annasver@hotmail.com |
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 |
Principal Investigator: | Anna Sverdlik, MD | Sheba Medical Center |
ClinicalTrials.gov Identifier: | NCT00229333 History of Changes |
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:
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 |