Status:
UNKNOWN
Study of Escitalopram Versus Placebo in the Treatment of Depressive Syndrome in Alzheimer's Disease, Vascular Dementia, and Mixed Vascular and Alzheimer's Dementia
Lead Sponsor:
Sheba Medical Center
Collaborating Sponsors:
H. Lundbeck A/S
Conditions:
Depressive Syndrome
Eligibility:
All Genders
60+ years
Phase:
PHASE4
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 A...
Eligibility Criteria
Inclusion
- 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
- General
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00229333
Start Date
December 1 2004
Last Update
August 29 2006
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Sheba Medical Center
Ramat Gan, Israel, 52621