Escitalopram and Depression in Elderly Alzheimer's Patients
Primary Purpose
Depressive Disorder
Status
Terminated
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Escitalopram
Sponsored by
About this trial
This is an interventional treatment trial for Depressive Disorder focused on measuring Alzheimer's disease, elderly, open-label, escitalopram
Eligibility Criteria
Inclusion Criteria:
- > 50 years
- Male & female
- Alzheimer's disease
- Depressive episode
Sites / Locations
- Mt. St. Joseph's Hospital
- Vancouver General Hospital
Outcomes
Primary Outcome Measures
Change in Cornell Scale for Depression in Dementia (CSDD) from baseline.
Secondary Outcome Measures
Montgomery-Åsberg Depression Rating Scale; Neuropsychiatric Inventory; Alzheimer's Disease Cooperative Study
Full Information
NCT ID
NCT00488670
First Posted
June 18, 2007
Last Updated
June 2, 2011
Sponsor
University of British Columbia
1. Study Identification
Unique Protocol Identification Number
NCT00488670
Brief Title
Escitalopram and Depression in Elderly Alzheimer's Patients
Official Title
An Open-label Study of Escitalopram in the Treatment of Major Depressive Disorder in Elderly Patients With Alzheimer's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Terminated
Why Stopped
Dr. Rabheru left VCH last year and the study was cancelled according to his research coordinator.
Study Start Date
December 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of British Columbia
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To investigate the effect of Escitalopram in a large and diverse of dementia patients suffering from depression.
Detailed Description
This study will assess the efficacy, tolerability, and safety of escitalopram in the treatment of Major Depressive Disorder in patients with Alzheimer's disease over a 24-week period. It will also assess the efficacy and tolerability of escitalopram after 12 weeks of treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder
Keywords
Alzheimer's disease, elderly, open-label, escitalopram
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Escitalopram
Intervention Description
See Detailed Description.
Primary Outcome Measure Information:
Title
Change in Cornell Scale for Depression in Dementia (CSDD) from baseline.
Secondary Outcome Measure Information:
Title
Montgomery-Åsberg Depression Rating Scale; Neuropsychiatric Inventory; Alzheimer's Disease Cooperative Study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
> 50 years
Male & female
Alzheimer's disease
Depressive episode
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kiran Rabheru, MD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mt. St. Joseph's Hospital
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Escitalopram and Depression in Elderly Alzheimer's Patients
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