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 recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2006 by Sheba Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
H. Lundbeck A/S
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00229333
First received: September 27, 2005
Last updated: August 28, 2006
Last verified: August 2006
  Purpose

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.


Condition Intervention Phase
Depressive Syndrome
Drug: Escitalopram
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • Cornell Scale for Depression in Dementia (CSDD) total score

Secondary Outcome Measures:
  • Cohen-Mansfield Agitation Inventory (CMAI; Cohen-Mansfield et al. 1989)

Estimated Enrollment: 40
Study Start Date: December 2004
  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00229333

Contacts
Contact: Anna Sverdlik, MD 972-54-4718424 annasver@hotmail.com

Locations
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         
Sponsors and Collaborators
Sheba Medical Center
H. Lundbeck A/S
Investigators
Principal Investigator: Anna Sverdlik, MD Sheba Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00229333     History of Changes
Other Study ID Numbers: SHEBA-03-3124-AS-CTIL
Study First Received: September 27, 2005
Last Updated: August 28, 2006
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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:
Alzheimer Disease
Dementia
Dementia, Vascular
Depressive Disorder
Syndrome
Vascular Diseases
Arterial Occlusive Diseases
Arteriosclerosis
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Disease
Intracranial Arterial Diseases
Intracranial Arteriosclerosis
Leukoencephalopathies
Mental Disorders
Mood Disorders
Nervous System Diseases
Neurodegenerative Diseases
Pathologic Processes
Tauopathies
Citalopram
Dexetimide
Anti-Dyskinesia Agents
Antidepressive Agents
Antidepressive Agents, Second-Generation
Antiparkinson Agents
Autonomic Agents

ClinicalTrials.gov processed this record on October 29, 2014