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EEG Biomarkers for Predicting Response to Antidepressant Therapy
This study is ongoing, but not recruiting participants.
Sponsored by: Aspect Medical Systems
Information provided by: Aspect Medical Systems
ClinicalTrials.gov Identifier: NCT00289523
  Purpose

The purpose of this study is to evaluate the potential early EEG predictors of an individual’s response to treatment with antidepressant medications.

Objectives:

  • Prospectively confirm accuracy of current EEG biomarker algorithm
  • Determine preferred clinical intervention for subjects with negative indicator
  • Identify predictors of worsening suicide ideation

Condition Intervention Phase
Major Depressive Disorder
Drug: Escitalopram, Bupropion XL
Phase IV

MedlinePlus related topics: Antidepressants Depression
Drug Information available for: Escitalopram Benzetimide Citalopram Citalopram hydrobromide Dexetimide Escitalopram oxalate Bupropion hydrochloride Bupropion
U.S. FDA Resources
Study Type: Observational
Study Design: Screening, Longitudinal, Defined Population, Prospective Study
Official Title: Biomarkers for Rapid Identification of Treatment Effectiveness in Major Depression (BRITE-MD), a Prospective, Randomized, Multi-Center Study to Determine the Efficacy of Selected EEG and Genotype Biomarkers for Predicting Response to Antidepressant Therapy With Escitalopram, Bupropion XL, or a Combination Treatment Regimen.

Further study details as provided by Aspect Medical Systems:

Estimated Enrollment: 375
Study Start Date: January 2006
Estimated Study Completion Date: June 2007
Detailed Description:

According to recent clinical studies sponsored by the NIH, fewer than half of subjects diagnosed with a major depressive episode respond to the first trial of an antidepressant medication. While the majority of subjects eventually respond to treatment with an antidepressant, failure with the first line medication puts subjects at increased risk for never receiving adequate treatment of their depression.

Several lines of reasoning support the rationale for further investigating EEG as a means of predicting response and resistance to antidepressants. Prior studies suggest that changes in neuronal activity in the anterior cingulate and prefrontal regions are related to depression and that changes in brain response to treatment may also produce alterations that can be detected by recoding frontal EEG activity.

In this protocol, we proposed to identify possible neurophysiologic indicators of treatment outcome in depression, particularly indicators of brain response that appear early (within 7 days) during treatment with antidepressants. We will test whether quantitative EEG (QEEG) biomarkers can be reliably associated with response or non-response to treatment with antidepressant medications, using both monotherapy and combination drug treatments.

Comparison(s):

Selecting the best treatment for subjects with resistance to an initial antidepressant poses a considerable challenge for clinicians. The most widely prescribed antidepressants usually require 4-6 weeks of therapeutic dosing before a marked clinical improvement in symptoms is observed. Therefore, determining the optimal regimen can take several weeks or months for subjects who are resistant to the first line antidepressant. A tool for predicting eventual clinical response to antidepressants could help inform and accelerate the process of identifying the most efficacious treatment option for a given subject.

  Eligibility

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject has diagnosis of Major Depressive Disorder

Exclusion Criteria:

  • Subject is suffering from cognitive, bipolar, or psychotic disorder
  • Subject has had a course of ECT within the past six months
  • Subject has any known contraindication for use of any of the study drugs
  • Subject has a known drug dependency or substance abuse within the past six mon ths
  • Subject is currently pregnant or not using a medically acceptable means of birth control
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00289523

Locations
United States, California
University of California, Los Angeles-Westwood
Los Angeles, California, United States, 90024
University of California, San Diego
San Diego, California, United States, 92161
University of California, Los Angeles-Harbor
Torrance, California, United States, 90509
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
Baylor University College of Medicine
Houston, Texas, United States, 77030
University of Texas, Southwestern
Dallas, Texas, United States, 75235
R/D Clinical Research, Inc.
Lake Jackson, Texas, United States, 77566
Sponsors and Collaborators
Aspect Medical Systems
Investigators
Principal Investigator: Andrew F Leuchter, M.D. University of California, Los Angeles-Westwood
  More Information

MedlinePlus related topics: Depression  This link exits the ClinicalTrials.gov site

Publications:
Study ID Numbers: 227
Study First Received: February 8, 2006
Last Updated: March 30, 2007
ClinicalTrials.gov Identifier: NCT00289523  
Health Authority: United States: Institutional Review Board

Keywords provided by Aspect Medical Systems:
Major Depressive Disorder, Depressive Disorder, Unipolar Depression, Antidepressants, Electroencephalography

Study placed in the following topic categories:
Dopamine
Depression
Mental Disorders
Bupropion
Mood Disorders
Depressive Disorder, Major
Dexetimide
Depressive Disorder
Citalopram
Serotonin
Behavioral Symptoms

Additional relevant MeSH terms:
Dopamine Uptake Inhibitors
Parasympatholytics
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiparkinson Agents
Cholinergic Agents
Serotonin Uptake Inhibitors
Pharmacologic Actions
Muscarinic Antagonists
Serotonin Agents
Autonomic Agents
Therapeutic Uses
Dopamine Agents
Peripheral Nervous System Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on January 16, 2009