NCT00926653

Brief Summary

This study will examine differences in activity of the anterior cingulate cortex, a brain area involved in emotion and cognitive regulation, between older adults with and without depression.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

June 22, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 23, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

August 11, 2015

Status Verified

August 1, 2015

Enrollment Period

4.8 years

First QC Date

June 22, 2009

Last Update Submit

August 10, 2015

Conditions

Keywords

Geriatric Depression

Outcome Measures

Primary Outcomes (1)

  • Cerebral activation, as measured using functional magnetic resonance imaging (fMRI)

    Average of a 2 hour MRI session

Study Arms (2)

Depressed

Elderly participants with depression

Drug: Escitalopram

Control

Elderly participants who have never experienced depression

Interventions

10 to 20 mg daily as part of another study in which participants are enrolled

Also known as: Lexapro
Depressed

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Depressed and control participants are recruited from the community, with additional depressed participants recruited from a geriatric outpatient clinic at New York Presbyterian/Weill Cornell Medical College.

You may qualify if:

  • Diagnosis of major depression by DSM-IV criteria
  • Mini-Mental State Examination (MMSE) score greater than 24
  • Severity score of 17 or higher on the 21-item Hamilton Depression Rating Scale score (HDRS) during the index episode
  • Residence less than a 45-minute drive from New York Hospital-Westchester Division

You may not qualify if:

  • Presence of psychotic depression, as defined by Research Diagnostic Criteria and DSM-IV
  • History of psychiatric disorders other than unipolar major depression (people with bipolar disorder and dysthymia will be excluded)
  • Presence of dementing disorders
  • Acute or severe medical illness, such as the following: delirium; metastatic cancer; decompensated cardiac, liver, or kidney failure; major surgery; or cerebrovascular accident or myocardial infarction 3 months prior to study entry
  • Receiving drugs known to cause depression, including reserpine, alpha-methyl-dopa, and steroids
  • Requires concomitant treatment with other psychotropics, including antipsychotic medications, lithium salts, stimulants, valproic acid, carbamazepine, or gabapentin
  • Severe aphasia interfering with communication
  • Contraindications to magnetic resonance (MR) scanning, such as implanted metal, claustrophobia, or weight greater than or equal to 300 lbs
  • MMSE score greater than 24
  • History of psychiatric disorder
  • Presence of dementing disorders
  • Acute or severe medical illness, such as the following: delirium; metastatic cancer; decompensated cardiac, liver, or kidney failure; major surgery; or cerebrovascular accident or myocardial infarction 3 months prior to study entry
  • Receiving drugs known to cause depression, including reserpine, alpha-methyl-dopa, and steroids
  • Current treatment with psychotropics
  • Severe aphasia interfering with communication
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York Presbyterian-Weill Cornell Medical College

White Plains, New York, 10605, United States

Location

MeSH Terms

Conditions

Depression

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic ChemicalsNitrilesBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Faith M. Gunning-Dixon, PhD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2009

First Posted

June 23, 2009

Study Start

July 1, 2005

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

August 11, 2015

Record last verified: 2015-08

Locations