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
Recruitment status was Active, not recruiting
Sponsor:
Weill Medical College of Cornell University
Collaborators:
Forest Laboratories
Information provided by:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00918684
First received: June 9, 2009
Last updated: February 18, 2011
Last verified: February 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Depression |
Drug: Escitalopram |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Aging White Matter Changes, Executive Dysfunction and Depression |
Resource links provided by NLM:
Further study details as provided by Weill Medical College of Cornell University:
Primary Outcome Measures:
- Hamilton Depression Rating Scale (depression severity) [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 116 |
| Study Start Date: | August 2002 |
| Estimated Study Completion Date: | May 2010 |
| Estimated Primary Completion Date: | May 2010 (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
10mg tab daily
Other Name: Lexapro
|
Eligibility| Ages Eligible for Study: | 60 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
- Aphasia.
- Residence outside a 45-minute drive from Cornell's clinical facilities.
- Patients taking MAOI's and Fluoxetine will be excluded.
Contacts and Locations More Information
No publications provided
| Responsible Party: | George S. Alexopoulos, MD, Weill Cornell Medical College |
| ClinicalTrials.gov Identifier: | NCT00918684 History of Changes |
| Other Study ID Numbers: | R01 MH065653-01A1, R01 MH065653-01A1 |
| Study First Received: | June 9, 2009 |
| 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 23, 2013