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EEG Biomarkers for Predicting Response to Antidepressant Therapy

This study is ongoing, but not recruiting participants.
Study NCT00289523.   Last updated on March 30, 2007.   Information provided by Aspect Medical Systems

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Descriptive Information Fields
Brief Title  EEG Biomarkers for Predicting Response to Antidepressant Therapy
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.
Brief Summary

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
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.

Study Phase Phase IV
Study Type  Observational
Study Design  Screening, Longitudinal, Defined Population, Prospective Study
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Major Depressive Disorder
Intervention  Drug: Escitalopram, Bupropion XL
MEDLINE PMIDs 15992554
Links MedlinePlus related topics: Depression This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Active, not recruiting
Enrollment  375
Start Date  January 2006
Completion Date June 2007
Eligibility 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
Gender Both
Ages 21 Years to 75 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00289523
Organization ID 227
Secondary IDs ††
Study Sponsor  Aspect Medical Systems
Collaborators ††
Investigators 
Principal Investigator:     Andrew F Leuchter, M.D.     University of California, Los Angeles-Westwood    
Information Provided By Aspect Medical Systems
Verification Date February 2007
First Received Date  February 8, 2006
Last Updated Date March 30, 2007

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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