Treatment Response of Geriatric Depression

NCT00754936 | Completed Results DMC

• 2 other identifiers: 0703009061R01MH079414-01A1
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine the relationship between brain electrical activity in elderly depressed patients and response to antidepressant medication treatment. Elderly patients with depression will be treated for 12 weeks with an antidepressant medication commonly used in clinical practice called escitalopram (Lexapro). Brain electrical activity will be assessed using electrophysiological tests. Researchers are interested in whether the brain electrical activity of elderly people with depression before they start the medication can tell us who amongst them will improve with antidepressant treatment and to what extent. They will also determine whether patients' brain electrical activity during the 12 weeks of medication treatment will change in any way and whether this change will be linked with a change in the severity of their depression. Researchers hope that information gained from this study will help to better understand the brain processes associated with depression and its successful treatment.

Conditions

Depression

Keywords

Depression

Outcome Measures

Primary Outcomes (1)

• Montgomery Asberg Depression Rating Scale (Depression Severity)

  A published and widely used scale for measuring severity of depression. Montgomery Asberg Depression Rating Scale scores can range from 0-60. Higher scores indicate greater severity of depression. Total scores are reported with no subscales.

  14 weeks from enrollment (12 weeks from medication start)

Secondary Outcomes (1)

• Hamilton Depression Rating Scale (Depression Severity)

  14 weeks from enrollment (12 weeks from medication start)

Study Arms (1)

Escitalopram

EXPERIMENTAL

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

Drug: Escitalopram

Interventions

Escitalopram DRUG

20 mg by mouth daily

Also known as: Lexapro

Escitalopram

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis: Major depression, unipolar without psychotic features (by DSM-IV criteria) -Severity of depression: A 24-Item HDRS above 19 at screening and at baseline -
• Level of Executive Dysfunction: Two strata within each age stratum: Stroop Color-Word scores - one half of the sample \< 26, one of half ≥ 26.
• Capacity to provide informed consent.

You may not qualify if:

• High suicide risk, i.e. intent or plan to attempt suicide in near future
• Presence of any current Axis I psychiatric disorder (other than unipolar major depression or specific phobias) including substance abuse (those with a history of substance abuse must be abstinent for at least 3 months prior to entry)
• Axis II diagnosis of antisocial personality disorder, mental retardation and pervasive developmental disorder (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, sympathomimetics withdrawal
• Presence of a significant neurological disease such as Parkinson's disease, primary or secondary seizure disorders, intracranial tumors, severe head trauma; neurodegenerative diseases i.e. MS
• History of failure to respond to escitalopram (Lexapro) (20mg/day for 6 weeks or longer) during the current or previous depressive episodes
• History of intolerance to escitalopram (Lexapro) or use of concomitant drugs that may provide reason to believe that escitalopram is contraindicated. Active treatment with fluoxetine at the time of screening
• Inability to speak English
• Aphasia

Sponsors & Collaborators

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

Study Sites (1)

Weill Cornell Medical College-Westchester Division

White Plains, New York, 10605, United States

Location

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: George S Alexopoulos
• Organization: Weill Cornell Medicine

gsalexop@med.cornell.edu

914-997-5767

Study Officials

• George Alexopoulos, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2008
• First Posted: September 18, 2008
• Study Start: May 1, 2007
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: March 19, 2019
• Results First Posted: March 19, 2019

Record last verified: 2019-02

Locations

US (1)