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Aging Brain Changes, Executive Dysfunction and Depression (FA)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2011 by Weill Medical College of Cornell University.
Recruitment status was:  Active, not recruiting
National Institute of Mental Health (NIMH)
Forest Laboratories
Information provided by:
Weill Medical College of Cornell University Identifier:
First received: June 9, 2009
Last updated: February 18, 2011
Last verified: February 2011
The purpose of this study is to look at the relationship between age related structural brain changes and changes in depressive symptoms,disability and several aspects of cognitive functioning following treatment with escitalopram.

Condition Intervention Phase
Drug: Escitalopram
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Aging White Matter Changes, Executive Dysfunction and Depression

Resource links provided by NLM:

Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • Hamilton Depression Rating Scale (depression severity) [ Time Frame: 14 weeks ]

Enrollment: 116
Study Start Date: August 2002
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Escitalopram
12-week open label with 2 week placebo period (14 weeks total)
Drug: Escitalopram
10mg tab daily
Other Name: Lexapro


Ages Eligible for Study:   60 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age: Two strata: 60-74 years (n=60) subjects and 75-84 years (n=60).
  2. Diagnosis: Major depression, unipolar (by DSM-IV criteria); or, for control subjects, no diagnosis of major depression, no history of depression or other psychiatric conditions.
  3. Severity of depression: A 24-Item HDRS above 19; Level of Executive Dysfunction: Two strata within each age stratum: Stroop Color-Word scores below and above 24 (1 SD below the median of our normal elderly sample).

Exclusion Criteria:

  1. Psychotic depression by DSM-IV, i.e., presence of delusions with a score higher than 2 (questionable delusion) rated by the Scale for Assessment of Positive Symptoms (SAPS; 51).
  2. High suicide risk, i.e. intent or plan to attempt suicide in near future.
  3. Presence of any Axis I psychiatric disorder or substance abuse other than unipolar major depression.
  4. Axis II diagnosis of antisocial personality (by SCID-P and DSM-IV).
  5. History of psychiatric disorders other than unipolar major depression or generalized anxiety disorder (bipolar disorder, hypomania, are exclusion criteria).
  6. Cognition: MMSE scores below 24 or diagnosis of dementia by DSM-IV.
  7. Acute or severe medical illness, i.e., delirium, metastatic cancer, decompensated cardiac, liver or kidney failure, major surgery, stroke or myocardial infarction during the three months prior to entry; or drugs known to cause depression, e.g., reserpine, alpha-methyl-dopa, steroids.
  8. Failure to respond to an adequate trial of escitalopram (10 mg/day or more for 6 weeks or longer) during the current or previous depressive episodes.
  9. Current involvement in psychotherapy.
  10. History of hypersensitivity to escitalopram or need to receive drugs that may interact with escitalopram.
  11. Inability to perform any of the ADLs (MAI: ADL subscale) even with assistance, e.g. walking with a cane is not an exclusion criterion.
  12. Inability to speak English.
  13. Aphasia.
  14. Residence outside a 45-minute drive from Cornell's clinical facilities.
  15. Patients taking MAOI's and Fluoxetine will be excluded.
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Please refer to this study by its identifier: NCT00918684

Sponsors and Collaborators
Weill Medical College of Cornell University
National Institute of Mental Health (NIMH)
Forest Laboratories
Principal Investigator: George S Alexopoulos, MD Weill Medical College of Cornell University
  More Information

Responsible Party: George S. Alexopoulos, MD, Weill Cornell Medical College Identifier: NCT00918684     History of Changes
Other Study ID Numbers: R01MH065653-01A1 ( US NIH Grant/Contract Award Number )
Study First Received: June 9, 2009
Last Updated: February 18, 2011

Keywords provided by Weill Medical College of Cornell University:

Additional relevant MeSH terms:
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents processed this record on April 28, 2017