Overview

Aging Brain Changes, Executive Dysfunction and Depression

Status:
Completed
Trial end date:
2010-05-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Weill Medical College of Cornell University
Collaborators:
Forest Laboratories
National Institute of Mental Health (NIMH)
Treatments:
Citalopram
Dexetimide
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.