Aging Brain Changes, Executive Dysfunction and Depression

NCT ID: NCT00918684

Last Updated: 2017-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-12-31
• Study Completion Date: 2010-05-31

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.

Conditions

Depression

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Escitalopram

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

Group Type: EXPERIMENTAL

Escitalopram

Intervention Type: DRUG

10mg tab daily

Interventions

Escitalopram

10mg tab daily

Intervention Type: DRUG

Other Intervention Names

Lexapro

Eligibility 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).

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Forest Laboratories

INDUSTRY

Sponsor Role: collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

George S Alexopoulos, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Other Identifiers

R01MH065653-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0204005523

Identifier Type: -

Identifier Source: org_study_id