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

Sponsor:

Collaborators:

National Institute of Mental Health (NIMH)

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

History of Changes

Tracking Information

First Received Date ^ICMJE

June 9, 2009

Last Updated Date

February 18, 2011

Start Date ^ICMJE

August 2002

Estimated Primary Completion Date

May 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Hamilton Depression Rating Scale (depression severity) [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

depression severity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00918684 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Aging Brain Changes, Executive Dysfunction and Depression

Official Title ^ICMJE

Aging White Matter Changes, Executive Dysfunction and Depression

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

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Depression

Intervention ^ICMJE

Drug: Escitalopram

10mg tab daily

Other Name: Lexapro

Study Arm (s)

Experimental: Escitalopram

12-week open label with 2 week placebo period (14 weeks total)

Intervention: Drug: Escitalopram

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

116

Estimated Completion Date

May 2010

Estimated Primary Completion Date

May 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

60 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00918684

Other Study ID Numbers ^ICMJE

R01 MH065653-01A1, R01 MH065653-01A1

Has Data Monitoring Committee

Yes

Responsible Party

George S. Alexopoulos, MD, Weill Cornell Medical College

Study Sponsor ^ICMJE

Weill Medical College of Cornell University

Collaborators ^ICMJE

National Institute of Mental Health (NIMH)
Forest Laboratories

Investigators ^ICMJE

Principal Investigator:

George S Alexopoulos, MD

Weill Medical College of Cornell University

Information Provided By

Weill Medical College of Cornell University

Verification Date

February 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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