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Aging Brain Changes, Executive Dysfunction and Depression (FA)

This study has been completed.
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Forest Laboratories
Information provided by (Responsible Party):
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00918684
First received: June 9, 2009
Last updated: April 4, 2017
Last verified: April 2017
  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: No masking
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. [ Time Frame: 14 weeks (12th week of treatment) ]
    A published and widely-used scale for rating depression severity, the Hamilton Depression Rating Scale 24 item total scores range from 0-76. Higher scores indicate greater severity of depression. Total scores are reported with no subscales.

  • WHODAS-II Disability Scale [ Time Frame: 14 weeks (12th week of treatment) ]
    A disability rating scale published by the World Health Organization, the WHODAS II total scores can range from 0-100. Higher scores indicate greater severity of disability. Total scores are reported with no subscales.

  • Stroop Color-Word Test [ Time Frame: 14 weeks (12th week of treatment) ]
    A published and widely used executive dysfunction test, the Stroop Color-Word total scores can range from 0-100. Higher scores indicate better memory functioning (no cognitive impairment). Total scores are reported with no subscales.


Enrollment: 116
Actual Study Start Date: December 2002
Study Completion Date: May 2010
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

Detailed Description:
Age-related brain changes have been associated with development of late-life depression. Prominent among aging-related changes is decline in white matter disproportionately affecting frontal structures.Based on previous findings, we conceptualized treatment resistance, disability, and executive dysfunction as clinical phenomena contributed, at least in part, by compromised integrity of frontal neural systems. The study focuses on frontal white matter abnormalities in geriatric depression and their relationship to treatment response, disability,and executive dysfunction.
  Eligibility

Ages Eligible for Study:   60 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age: Two strata: 60-74 years (n=60) subjects and 75-84 years (n=60).
  2. 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.
  3. 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:

  1. 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).
  2. High suicide risk, i.e. intent or plan to attempt suicide in near future.
  3. Presence of any Axis I psychiatric disorder or substance abuse other than unipolar major depression.
  4. Axis II diagnosis of antisocial personality (by SCID-P and DSM-IV).
  5. History of psychiatric disorders other than unipolar major depression or generalized anxiety disorder (bipolar disorder, hypomania, are exclusion criteria).
  6. Cognition: MMSE scores below 24 or diagnosis of dementia by DSM-IV.
  7. 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.
  8. 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.
  9. Current involvement in psychotherapy.
  10. History of hypersensitivity to escitalopram or need to receive drugs that may interact with escitalopram.
  11. Inability to perform any of the ADLs (MAI: ADL subscale) even with assistance, e.g. walking with a cane is not an exclusion criterion.
  12. Inability to speak English.
  13. Aphasia.
  14. Residence outside a 45-minute drive from Cornell's clinical facilities.
  15. Patients taking MAOI's and Fluoxetine will be excluded.
  Contacts and Locations
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

Sponsors and Collaborators
Weill Medical College of Cornell University
National Institute of Mental Health (NIMH)
Forest Laboratories
Investigators
Principal Investigator: George S Alexopoulos, MD Weill Medical College of Cornell University
  More Information

Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00918684     History of Changes
Other Study ID Numbers: 0204005523
R01MH065653-01A1 ( US NIH Grant/Contract Award Number )
Study First Received: June 9, 2009
Results First Received: February 17, 2017
Last Updated: April 4, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Weill Medical College of Cornell University:
Depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Citalopram
Dexetimide
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents

ClinicalTrials.gov processed this record on May 25, 2017