Aging Brain Changes, Executive Dysfunction and Depression (FA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Weill Medical College of Cornell University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Forest Laboratories
Information provided by:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00918684
First received: June 9, 2009
Last updated: February 18, 2011
Last verified: February 2011
  Purpose

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
Depression
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 ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   60 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00918684

Sponsors and Collaborators
Weill Medical College of Cornell University
Forest Laboratories
Investigators
Principal Investigator: George S Alexopoulos, MD Weill Medical College of Cornell University
  More Information

No publications provided

Responsible Party: George S. Alexopoulos, MD, Weill Cornell Medical College
ClinicalTrials.gov Identifier: NCT00918684     History of Changes
Other Study ID Numbers: R01 MH065653-01A1, R01 MH065653-01A1
Study First Received: June 9, 2009
Last Updated: February 18, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:
Depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Dexetimide
Citalopram
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents

ClinicalTrials.gov processed this record on April 22, 2014