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Treatment Response of Geriatric Depression (ERP)
This study is currently recruiting participants.
Verified by Weill Medical College of Cornell University, March 2009
First Received: September 17, 2008   Last Updated: March 10, 2009   History of Changes
Sponsors and Collaborators: Weill Medical College of Cornell University
Forest Laboratories
Information provided by: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00754936
  Purpose

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 depression will be treated for 12 weeks with an antidepressant medication commonly used in clinical practice called escitalopram (Lexapro). Brain electrical activity will be assessed using electrophysiological tests. Researchers are interested in whether the brain electrical activity of elderly people with depression before they start the medication can tell us who amongst them will improve with antidepressant treatment and to what extent. They will also determine whether patients' brain electrical activity during the 12 weeks of medication treatment will change in any way and whether this change will be linked with a change in the severity of their depression. Researchers hope that information gained from this study will help to better understand the brain processes associated with depression and its successful treatment.


Condition Intervention
Depression
Drug: Escitalopram

MedlinePlus related topics: Antidepressants Depression
Drug Information available for: Benzetimide Dexetimide Citalopram hydrobromide Citalopram Escitalopram Escitalopram oxalate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Single Group Assignment, Efficacy Study
Official Title: ERPs, Cognitive Dysfunction and Treatment Response of Geriatric Depression

Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • Depression severity [ Time Frame: Weekly ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: May 2007
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Escitalopram
    20 mg by mouth daily
  Eligibility

Ages Eligible for Study:   60 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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, hypomania, and dysthymia 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 electroconvulsive therapy
  • History of failure to respond to escitalopram (Lexapro) (20mg/day for 6 weeks or longer) during the current or previous depressive episodes
  • Current psychotherapy
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00754936

Locations
United States, New York
Weill Cornell Medical College-Westchester Division Recruiting
White Plains, New York, United States, 10605
Contact: Christy Lim     914-997-4331        
Principal Investigator: George Alexopoulos, MD            
Sponsors and Collaborators
Weill Medical College of Cornell University
Forest Laboratories
Investigators
Principal Investigator: George Alexopoulos, MD Weill Cornell Medical College
  More Information

No publications provided

Responsible Party: Weill Cornell Medical College ( George Alexopoulos, MD )
Study ID Numbers: R01 MH079414-01A1, R01 MH079414-01A1
Study First Received: September 17, 2008
Last Updated: March 10, 2009
ClinicalTrials.gov Identifier: NCT00754936     History of Changes
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Neurotransmitter Agents
Depression
Psychotropic Drugs
Depressive Disorder
Citalopram
Serotonin Uptake Inhibitors
Serotonin
Behavioral Symptoms
Mental Disorders
Mood Disorders
Dexetimide
Antidepressive Agents, Second-Generation
Antidepressive Agents

Additional relevant MeSH terms:
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Depression
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Depressive Disorder
Citalopram
Serotonin Uptake Inhibitors
Pharmacologic Actions
Behavioral Symptoms
Serotonin Agents
Mental Disorders
Therapeutic Uses
Mood Disorders
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on May 07, 2009