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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00229333

Enrollment

Registered

2005-09-29

Start date

2004-12-31

Completion date

Unknown

Last updated

2006-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depressive Syndrome

Keywords

Escitalopram, Depression, Dementia, Treatment, Depressive Syndrome in Alzheimer's Disease, Depressive Syndrome in Vascular Dementia, Depressive Syndrome in Mixed Vascular and Alzheimer's Dementia

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.

Interventions

DRUGEscitalopram

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

60 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Cornell Scale for Depression in Dementia (CSDD) total score	—

Secondary

Measure	Time frame
Cohen-Mansfield Agitation Inventory (CMAI; Cohen-Mansfield et al. 1989)	—

Countries

Israel

Contacts

Primary ContactAnna Sverdlik, MD

annasver@hotmail.com972-54-4718424

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026