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

Condition(s) targeted: Depressive Syndrome

Intervention: Escitalopram (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Sheba Medical Center

Official(s) and/or principal investigator(s):
Anna Sverdlik, MD, Principal Investigator, Affiliation: Sheba Medical Center

Overall contact:
Anna Sverdlik, MD, Phone: 972-54-4718424, Email: annasver@hotmail.com

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.

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 design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: Cornell Scale for Depression in Dementia (CSDD) total score

Secondary outcome: Cohen-Mansfield Agitation Inventory (CMAI; Cohen-Mansfield et al. 1989)

Minimum age: 60 Years. Maximum age: N/A. Gender(s): Both.

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.

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

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

Starting date: December 2004
Last updated: August 28, 2006