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
Information provided by:
Weill Medical College of Cornell University
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.
||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Aging White Matter Changes, Executive Dysfunction and Depression
Primary Outcome Measures:
- Hamilton Depression Rating Scale (depression severity) [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||May 2010 (Final data collection date for primary outcome measure)
12-week open label with 2 week placebo period (14 weeks total)
10mg tab daily
Other Name: Lexapro
|Ages Eligible for Study:
||60 Years to 85 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Age: Two strata: 60-74 years (n=60) subjects and 75-84 years (n=60).
- 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.
- 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).
- 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).
- High suicide risk, i.e. intent or plan to attempt suicide in near future.
- Presence of any Axis I psychiatric disorder or substance abuse other than unipolar major depression.
- Axis II diagnosis of antisocial personality (by SCID-P and DSM-IV).
- History of psychiatric disorders other than unipolar major depression or generalized anxiety disorder (bipolar disorder, hypomania, are exclusion criteria).
- Cognition: MMSE scores below 24 or diagnosis of dementia by DSM-IV.
- 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.
- 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.
- Current involvement in psychotherapy.
- History of hypersensitivity to escitalopram or need to receive drugs that may interact with escitalopram.
- Inability to perform any of the ADLs (MAI: ADL subscale) even with assistance, e.g. walking with a cane is not an exclusion criterion.
- Inability to speak English.
- Residence outside a 45-minute drive from Cornell's clinical facilities.
- Patients taking MAOI's and Fluoxetine will be excluded.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00918684
Weill Medical College of Cornell University
||George S Alexopoulos, MD
||Weill Medical College of Cornell University
No publications provided
||George S. Alexopoulos, MD, Weill Cornell Medical College
History of Changes
|Other Study ID Numbers:
||R01 MH065653-01A1, R01 MH065653-01A1
|Study First Received:
||June 9, 2009
||February 18, 2011
||United States: Institutional Review Board
Keywords provided by Weill Medical College of Cornell University:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 19, 2014
Central Nervous System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Antidepressive Agents, Second-Generation