Aging Brain Changes, Executive Dysfunction and Depression (FA)

Aging White Matter Changes, Executive Dysfunction and Depression

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.

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Drug: 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.

• Study Type: Interventional
• Enrollment (Actual): 116
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Escitalopram; 12-week open label with 2 week placebo period (14 weeks total)	Drug: Escitalopram; 10mg tab daily; Other Names: Lexapro

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	14 weeks (12th week of treatment)
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.	14 weeks (12th week of treatment)
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.	14 weeks (12th week of treatment)

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Collaborators: National Institute of Mental Health (NIMH); Forest Laboratories
• Investigators: Principal Investigator: George S Alexopoulos, MD, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2002
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: June 9, 2009
• First Submitted That Met QC Criteria: June 10, 2009
• First Posted (Estimate): June 11, 2009

Study Record Updates

• Last Update Posted (Actual): May 12, 2017
• Last Update Submitted That Met QC Criteria: April 4, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Depression
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Antidepressive Agents, Second-Generation; Citalopram
• Other Study ID Numbers: 0204005523; R01MH065653-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED