- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01477268
Cognitive Correlates of Antidepressant Treatment Response in Elders
November 18, 2011 updated by: Unity Health Toronto
Determining the Impact of Dementia and Executive Impairment on Antidepressant Treatment Response in Older Persons
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5B 1W8
- St Michael's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years to 90 years (OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: zoloft
Both arms of the study will include zoloft.
However, the treatment response to zoloft will be compared in two different subgroups.
|
Zoloft 50-200 mg po od x 12 weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
depression
Time Frame: June 1, 2007 - June 1, 2008
|
June 1, 2007 - June 1, 2008
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Corinne Fischer, MD, St. Michaels Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2007
Primary Completion (ACTUAL)
April 1, 2009
Study Completion (ACTUAL)
October 1, 2009
Study Registration Dates
First Submitted
June 9, 2009
First Submitted That Met QC Criteria
November 18, 2011
First Posted (ESTIMATE)
November 22, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
November 22, 2011
Last Update Submitted That Met QC Criteria
November 18, 2011
Last Verified
May 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 06-296
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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