Escitalopram and Depression in Elderly Alzheimer's Patients | NCT00488670

Studies
Escitalopram and Depression in Elderly Alzheimer's Patients

NCT00488670

Sponsor

University of British Columbia

Status

Terminated

Last Update Posted

Jun 6, 2011Estimated

Enrollment

50Estimated

Phase

Phase 3

Conditions

Depressive Disorder

Interventions

Escitalopram

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2011

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Dr. Rabheru left VCH last year and the study was cancelled according to his research coordinator.

Expanded Access Info

Start Date

Dec 2010

Primary Completion Date

Jun 2011Actual

Completion Date

Jun 2011Actual

First Submitted Date

Jun 18, 2007

First Submission Date that Met QC Criteria

Jun 19, 2007

First Posted Date

Jun 20, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 2, 2011

Last Update Posted Date

Jun 6, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Name	Type	Description	Arm Group Labels	Other Names
Escitalopram	Drug	See Detailed Description.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Cornell Scale for Depression in Dementia (CSDD) from baseline.

Secondary Outcomes

Measure	Description	Time Frame
Montgomery-Åsberg Depression Rating Scale; Neuropsychiatric Inventory; Alzheimer's Disease Cooperative Study

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

> 50 years
Male & female
Alzheimer's disease
Depressive episode

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kiran Rabheru, MD	University of British Columbia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mt. St. Joseph's Hospital		Vancouver	British Columbia		Canada
Vancouver General Hospital

Condition Browse Module

MeSH Terms

ID	Term
D003866	Depressive Disorder
D000544	Alzheimer Disease

Ancestor Terms

ID	Term
D019964	Mood Disorders
D001523	Mental Disorders
D003704	Dementia
D001927	Brain Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000089983	Escitalopram

Ancestor Terms

ID	Term
D011437	Propylamines
D000588	Amines
D009930	Organic Chemicals
D009570	Nitriles
D001572

Browse Leaves

Not provided

Browse Branches

Not provided