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

September 27, 2005
August 28, 2006
December 2004
Not Provided
Cornell Scale for Depression in Dementia (CSDD) total score
Cornell Scale for Depression in Dementia (CSDD) total score.
Complete list of historical versions of study NCT00229333 on ClinicalTrials.gov Archive Site
Cohen-Mansfield Agitation Inventory (CMAI; Cohen-Mansfield et al. 1989)
Cohen-Mansfield Agitation Inventory (CMAI; Cohen-Mansfield et al. 1989).
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Depressive Syndrome
Drug: Escitalopram
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
Not Provided
Not Provided

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.
Both
60 Years and older
No
Contact: Anna Sverdlik, MD 972-54-4718424 annasver@hotmail.com
Israel
 
NCT00229333
SHEBA-03-3124-AS-CTIL
Not Provided
Not Provided
Sheba Medical Center
H. Lundbeck A/S
Principal Investigator: Anna Sverdlik, MD Sheba Medical Center
Sheba Medical Center
August 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP