Status:
COMPLETED
Treatment Response of Geriatric Depression
Lead Sponsor:
Weill Medical College of Cornell University
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Forest Laboratories
Conditions:
Depression
Eligibility:
All Genders
60-90 years
Phase:
NA
Brief Summary
The purpose of this study is to examine the relationship between brain electrical activity in elderly depressed patients and response to antidepressant medication treatment. Elderly patients with depr...
Detailed Description
This research study will examine how the brain electrical activity of elderly depressed patients is related to how quickly and how well they respond to antidepressant medication treatment. Brain elect...
Eligibility Criteria
Inclusion
- Diagnosis: Major depression, unipolar without psychotic features (by DSM-IV criteria) -Severity of depression: A 24-Item HDRS above 19 at screening and at baseline -
- Level of Executive Dysfunction: Two strata within each age stratum: Stroop Color-Word scores - one half of the sample \< 26, one of half ≥ 26.
- Capacity to provide informed consent.
Exclusion
- High suicide risk, i.e. intent or plan to attempt suicide in near future
- Presence of any current Axis I psychiatric disorder (other than unipolar major depression or specific phobias) including substance abuse (those with a history of substance abuse must be abstinent for at least 3 months prior to entry)
- Axis II diagnosis of antisocial personality disorder, mental retardation and pervasive developmental disorder (DSM-IV)
- History of psychiatric disorders such as psychotic depression, primary psychotic disorder, or bipolar spectrum disorder (bipolar disorder and hypomania are exclusions)
- 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, sympathomimetics withdrawal
- Presence of a significant neurological disease such as Parkinson's disease, primary or secondary seizure disorders, intracranial tumors, severe head trauma; neurodegenerative diseases i.e. MS
- History of failure to respond to escitalopram (Lexapro) (20mg/day for 6 weeks or longer) during the current or previous depressive episodes
- History of intolerance to escitalopram (Lexapro) or use of concomitant drugs that may provide reason to believe that escitalopram is contraindicated. Active treatment with fluoxetine at the time of screening
- Patients' unwillingness or inability to gradually withdraw all other psychotropic medications (except for the following: Low and stable doses of opiates and non-benzodiazepine hypnotics (e.g. zolpidem (5 or 10 mg), zaleplon (5 or 10 mg), or eszopiclone (1 or 2 mg).Low and stable doses of diazepam and other anxiolytics should be tapered at screening; inability to tolerate taper is not an exclusion criteria.
- 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
- Aphasia
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT00754936
Start Date
May 1 2007
End Date
May 1 2015
Last Update
March 19 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Weill Cornell Medical College-Westchester Division
White Plains, New York, United States, 10605