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Cognitive Correlates of Antidepressant Treatment Response in Elders

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01477268
First Posted: November 22, 2011
Last Update Posted: November 22, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
St. Michael's Hospital, Toronto
  Purpose
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.

Condition Intervention Phase
Depression Drug: Zoloft (antidepressant) Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Determining the Impact of Dementia and Executive Impairment on Antidepressant Treatment Response in Older Persons

Resource links provided by NLM:


Further study details as provided by St. Michael's Hospital, Toronto:

Primary Outcome Measures:
  • depression [ Time Frame: June 1, 2007 - June 1, 2008 ]

Enrollment: 30
Study Start Date: June 2007
Study Completion Date: October 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
zoloft
Both arms of the study will include zoloft. However, the treatment response to zoloft will be compared in two different subgroups.
Drug: Zoloft (antidepressant)
Zoloft 50-200 mg po od x 12 weeks
Other Name: Sertraline

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01477268


Locations
Canada, Ontario
St Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Investigators
Principal Investigator: Corinne Fischer, MD St. Michaels Hospital
  More Information

Responsible Party: Dr. Corinne E. Fischer, St. Michael's Hospital
ClinicalTrials.gov Identifier: NCT01477268     History of Changes
Other Study ID Numbers: 06-296
First Submitted: June 9, 2009
First Posted: November 22, 2011
Last Update Posted: November 22, 2011
Last Verified: May 2011

Keywords provided by St. Michael's Hospital, Toronto:
antidepressants
depression
zoloft
psychiatry
psychology

Additional relevant MeSH terms:
Depression
Behavioral Symptoms
Antidepressive Agents
Sertraline
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs