This trial is active, not recruiting.

Condition depression
Treatment escitalopram
Phase phase 4
Sponsor Weill Medical College of Cornell University
Collaborator National Institute of Mental Health (NIMH)
Start date August 2002
End date May 2010
Trial size 116 participants
Trial identifier NCT00918684, R01 MH065653-01A1


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
12-week open label with 2 week placebo period (14 weeks total)
escitalopram Lexapro
10mg tab daily

Primary Outcomes

Hamilton Depression Rating Scale (depression severity)
time frame: 14 weeks

Eligibility Criteria

Male or female participants from 60 years up to 85 years old.

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.

Additional Information

Official title Aging White Matter Changes, Executive Dysfunction and Depression
Principal investigator George S Alexopoulos, MD
Trial information was received from ClinicalTrials.gov and was last updated in February 2011.
Information provided to ClinicalTrials.gov by Weill Medical College of Cornell University.