Back to resultsCognitive Correlates of Antidepressant Treatment Response in Elders
Primary Purpose
Depression
Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Zoloft (antidepressant)
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring antidepressants, depression, zoloft, psychiatry, psychology
Eligibility Criteria
Inclusion Criteria:
- above the age of 65,
- speak English fluently,
- experience depression, AND
- not yet on active treatment.
Exclusion Criteria:
- active delirium,
- substance abuse,
- mental illness other than major depression,
- active CNS disease,
- unstable systematic medical disease, OR
- current of past psychotic disorder.
Sites / Locations
- St Michael's Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
zoloft
Arm Description
Both arms of the study will include zoloft. However, the treatment response to zoloft will be compared in two different subgroups.
Outcomes
Primary Outcome Measures
depression
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01477268
Brief Title
Cognitive Correlates of Antidepressant Treatment Response in Elders
Official Title
Determining the Impact of Dementia and Executive Impairment on Antidepressant Treatment Response in Older Persons
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Unity Health Toronto
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Major depression is a very common health problem affecting older persons. The present standard of treatment is with medications called "antidepressants". Antidepressants have been studied extensively in older persons with normal brain function and have been shown to be effective. However, certain types of brain dysfunction called "executive impairment" (inability to do higher order thinking) may lead to poor treatment outcomes. This study will compare how older depressed people with different levels of executive impairment respond differently to standard antidepressant treatment. Knowing this information will lead to more rational targeting of available treatments, leading to improved treatment outcomes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
antidepressants, depression, zoloft, psychiatry, psychology
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
zoloft
Arm Type
Other
Arm Description
Both arms of the study will include zoloft. However, the treatment response to zoloft will be compared in two different subgroups.
Intervention Type
Drug
Intervention Name(s)
Zoloft (antidepressant)
Other Intervention Name(s)
Sertraline
Intervention Description
Zoloft 50-200 mg po od x 12 weeks
Primary Outcome Measure Information:
Title
depression
Time Frame
June 1, 2007 - June 1, 2008
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
above the age of 65,
speak English fluently,
experience depression, AND
not yet on active treatment.
Exclusion Criteria:
active delirium,
substance abuse,
mental illness other than major depression,
active CNS disease,
unstable systematic medical disease, OR
current of past psychotic disorder.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Corinne Fischer, MD
Organizational Affiliation
St. Michaels Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
St Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Cognitive Correlates of Antidepressant Treatment Response in Elders
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