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Aging Brain Changes, Executive Dysfunction and Depression (FA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00918684
First Posted: June 11, 2009
Last Update Posted: May 12, 2017
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.
Collaborators:
National Institute of Mental Health (NIMH)
Forest Laboratories
Information provided by (Responsible Party):
Weill Medical College of Cornell University
June 9, 2009
June 11, 2009
February 17, 2017
May 12, 2017
May 12, 2017
December 2002
May 2010   (Final data collection date for primary outcome measure)
  • Hamilton Depression Rating Scale. [ Time Frame: 14 weeks (12th week of treatment) ]
    A published and widely-used scale for rating depression severity, the Hamilton Depression Rating Scale 24 item total scores range from 0-76. Higher scores indicate greater severity of depression. Total scores are reported with no subscales.
  • WHODAS-II Disability Scale [ Time Frame: 14 weeks (12th week of treatment) ]
    A disability rating scale published by the World Health Organization, the WHODAS II total scores can range from 0-100. Higher scores indicate greater severity of disability. Total scores are reported with no subscales.
  • Stroop Color-Word Test [ Time Frame: 14 weeks (12th week of treatment) ]
    A published and widely used executive dysfunction test, the Stroop Color-Word total scores can range from 0-100. Higher scores indicate better memory functioning (no cognitive impairment). Total scores are reported with no subscales.
depression severity [ Time Frame: 12 weeks ]
Complete list of historical versions of study NCT00918684 on ClinicalTrials.gov Archive Site
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Aging Brain Changes, Executive Dysfunction and Depression
Aging White Matter Changes, Executive Dysfunction and Depression
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.
Age-related brain changes have been associated with development of late-life depression. Prominent among aging-related changes is decline in white matter disproportionately affecting frontal structures.Based on previous findings, we conceptualized treatment resistance, disability, and executive dysfunction as clinical phenomena contributed, at least in part, by compromised integrity of frontal neural systems. The study focuses on frontal white matter abnormalities in geriatric depression and their relationship to treatment response, disability,and executive dysfunction.
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Depression
Drug: Escitalopram
10mg tab daily
Other Name: Lexapro
Experimental: Escitalopram
12-week open label with 2 week placebo period (14 weeks total)
Intervention: Drug: Escitalopram
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
116
May 2010
May 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
60 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00918684
0204005523
R01MH065653-01A1 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Plan to Share IPD: Undecided
Weill Medical College of Cornell University
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
Weill Medical College of Cornell University
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP