Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

June 9, 2009
February 18, 2011
August 2002
May 2010   (final data collection date for primary outcome measure)
Hamilton Depression Rating Scale (depression severity) [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
depression severity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00918684 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: 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.
 
Active, not recruiting
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.
Both
60 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00918684
R01 MH065653-01A1, R01 MH065653-01A1
Yes
George S. Alexopoulos, MD, Weill Cornell Medical College
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
February 2011

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