Treatment Response of Geriatric Depression (ERP)
Recruitment status was Recruiting
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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 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | ERPs, Cognitive Dysfunction and Treatment Response of Geriatric Depression |
- Montgomery Asberg Depression Rating Scale (Depression severity) [ Time Frame: 14 Weeks ] [ Designated as safety issue: No ]
- Hamilton Depression Rating Scale (Depression Severity) [ Time Frame: 14 Weeks ] [ 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) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Escitalopram
12 week open label with 2 week placebo period (14 weeks total)
|
Drug: Escitalopram
20 mg by mouth daily
Other Name: Lexapro
|
Eligibility| Ages Eligible for Study: | 60 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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 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
Contacts and 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 | |
| Principal Investigator: | George Alexopoulos, MD | Weill Medical College of Cornell University |
More Information
No publications provided
| Responsible Party: | George Alexopoulos, MD, Weill Cornell Medical College |
| ClinicalTrials.gov Identifier: | NCT00754936 History of Changes |
| Other Study ID Numbers: | R01 MH079414-01A1, R01 MH079414-01A1 |
| Study First Received: | September 17, 2008 |
| Last Updated: | February 18, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Weill Medical College of Cornell University:
|
Depression |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders Dexetimide Citalopram Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Parasympatholytics Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Serotonin Agents |
ClinicalTrials.gov processed this record on May 16, 2013