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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.
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
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.
Age
21 - 75 years
Sex
ALL
Healthy Volunteers
No
University of California, Los Angeles-Westwood
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
University of California, San Diego
San Diego, California, United States
University of California, Los Angeles-Harbor
Torrance, California, United States
Northwestern University
Chicago, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
University of Texas, Southwestern
Dallas, Texas, United States
Baylor University College of Medicine
Houston, Texas, United States
R/D Clinical Research, Inc.
Lake Jackson, Texas, United States
Start Date
January 1, 2006
Primary Completion Date
July 1, 2007
Completion Date
July 1, 2007
Last Updated
March 7, 2012
375
ACTUAL participants
Lead Sponsor
Medtronic - MITG
NCT07115329
NCT06793397
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07025720