Aging Brain Changes, Executive Dysfunction and Depression

Depression Clinical Trial

— FA  

Official title:

Aging White Matter Changes, Executive Dysfunction and Depression

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00918684
• Other study ID #: R01MH065653-01A1
• Secondary ID: R01MH065653-01A1
• Status: Active, not recruiting
• Phase: Phase 4
• First received: June 9, 2009
• Last updated: February 18, 2011
• Start date: August 2002
• Est. completion date: May 2010

Study information

• Verified date: February 2011
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 116
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years to 85 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Drug:
• Escitalopram
10mg tab daily

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	Forest Laboratories, National Institute of Mental Health (NIMH)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Depression Rating Scale (depression severity)		14 weeks	No