Back to resultsAging Brain Changes, Executive Dysfunction and Depression (FA)
Primary Purpose
Depression
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Escitalopram
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring Depression
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Escitalopram
Arm Description
12-week open label with 2 week placebo period (14 weeks total)
Outcomes
Primary Outcome Measures
Hamilton Depression Rating Scale.
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
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
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00918684
First Posted
June 9, 2009
Last Updated
April 4, 2017
Sponsor
Weill Medical College of Cornell University
Collaborators
National Institute of Mental Health (NIMH), Forest Laboratories
1. Study Identification
Unique Protocol Identification Number
NCT00918684
Brief Title
Aging Brain Changes, Executive Dysfunction and Depression
Acronym
FA
Official Title
Aging White Matter Changes, Executive Dysfunction and Depression
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
December 2002 (Actual)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
National Institute of Mental Health (NIMH), Forest Laboratories
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
116 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Escitalopram
Arm Type
Experimental
Arm Description
12-week open label with 2 week placebo period (14 weeks total)
Intervention Type
Drug
Intervention Name(s)
Escitalopram
Other Intervention Name(s)
Lexapro
Intervention Description
10mg tab daily
Primary Outcome Measure Information:
Title
Hamilton Depression Rating Scale.
Description
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.
Time Frame
14 weeks (12th week of treatment)
Title
WHODAS-II Disability Scale
Description
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.
Time Frame
14 weeks (12th week of treatment)
Title
Stroop Color-Word Test
Description
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.
Time Frame
14 weeks (12th week of treatment)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George S Alexopoulos, MD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Aging Brain Changes, Executive Dysfunction and Depression
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