Aging Brain Changes, Executive Dysfunction and Depression

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00918684
• Date of registration: 09/06/2009
• Primary sponsor: Weill Medical College of Cornell University
• Public title: Aging Brain Changes, Executive Dysfunction and Depression FA
• Scientific title: Aging White Matter Changes, Executive Dysfunction and Depression
• Date of first enrolment: August 2002
• Target sample size: 116
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT00918684
• Study type: Interventional
• Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Contacts

• Name: George S Alexopoulos, MD
• Affiliation: Weill Medical College of Cornell University

Key inclusion & exclusion 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.



Age minimum: 60 Years
Age maximum: 85 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Depression

Intervention(s)

Drug: Escitalopram

Primary Outcome(s)

Hamilton Depression Rating Scale (depression severity) [Time Frame: 14 weeks]

Secondary ID(s)

R01 MH065653-01A1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Forest Laboratories

National Institute of Mental Health (NIMH)