Aging Brain Changes, Executive Dysfunction and Depression

NCT00918684 | Completed Phase 4 Results DMC

• 2 other identifiers: 0204005523R01MH065653-01A1
• Study Type: interventional
• Target: 116
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Depression

Keywords

Depression

Outcome Measures

Primary Outcomes (3)

• 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)

Study Arms (1)

Escitalopram

EXPERIMENTAL

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

Drug: Escitalopram

Interventions

Escitalopram DRUG

10mg tab daily

Also known as: Lexapro

Escitalopram

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: Two strata: 60-74 years (n=60) subjects and 75-84 years (n=60).
• 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.
• 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).

You may not qualify if:

• 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).
• High suicide risk, i.e. intent or plan to attempt suicide in near future.
• Presence of any Axis I psychiatric disorder or substance abuse other than unipolar major depression.
• Axis II diagnosis of antisocial personality (by SCID-P and DSM-IV).
• Cognition: MMSE scores below 24 or diagnosis of dementia by DSM-IV.
• 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.
• 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.
• Current involvement in psychotherapy.
• History of hypersensitivity to escitalopram or need to receive drugs that may interact with escitalopram.
• Inability to speak English.
• Aphasia.
• Residence outside a 45-minute drive from Cornell's clinical facilities.
• Patients taking MAOI's and Fluoxetine will be excluded.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• National Institute of Mental Health (NIMH): collaborator
• Forest Laboratories: collaborator

MeSH Terms

Conditions

Depression

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. George Alexopoulos, M.D.
• Organization: Weill Cornell Medical College

galexopoulos@med.cornell.edu

914-997-5767

Study Officials

• George S Alexopoulos, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2009
• First Posted: June 11, 2009
• Study Start: December 1, 2002
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: May 12, 2017
• Results First Posted: May 12, 2017

Record last verified: 2017-04