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

NCT ID: NCT00229333

Last Updated: 2006-08-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Escitalopram

Intervention Type: DRUG

Eligibility 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

• 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.

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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

H. Lundbeck A/S

INDUSTRY

Sponsor Role: collaborator

Sheba Medical Center

OTHER_GOV

Sponsor Role: lead

Principal Investigators

Anna Sverdlik, MD

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Locations

Sheba Medical Center

Ramat Gan, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Anna Sverdlik, MD

Role: CONTACT

Phone: 972-54-4718424

Email: annasver@hotmail.com

Facility Contacts

Anna Sverdlik, MD

Role: primary

Aviva Cohen, BA

Role: backup

Other Identifiers

SHEBA-03-3124-AS-CTIL

Identifier Type: -

Identifier Source: org_study_id