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

NCT00229333 | Unknown Phase 4

• 1 other identifier: SHEBA-03-3124-AS-CTIL
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Cornell Scale for Depression in Dementia (CSDD) total score

Secondary Outcomes (1)

• Cohen-Mansfield Agitation Inventory (CMAI; Cohen-Mansfield et al. 1989)

Interventions

Escitalopram DRUG

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Sheba Medical Center: lead
• H. Lundbeck A/S: collaborator

Study Sites (1)

Sheba Medical Center

Ramat Gan, 52621, Israel

RECRUITING

MeSH Terms

Conditions

Depressive Disorder; Depression; Dementia; Alzheimer Disease

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Tauopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Anna Sverdlik, MD

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Sverdlik, MD

CONTACT

972-54-4718424; annasver@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: September 27, 2005
• First Posted: September 29, 2005
• Study Start: December 1, 2004
• Last Updated: August 29, 2006

Record last verified: 2006-08

Locations

IL (1)