EEG Biomarkers for Predicting Response to Antidepressant Therapy

Major Depressive Disorder Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00289523
• Other study ID #: 227
• Status: Completed
• Phase: Phase 4
• First received: February 8, 2006
• Last updated: March 6, 2012
• Start date: January 2006
• Est. completion date: July 2007

Study information

• Verified date: April 2010
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 375
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 75 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Northwestern University	Chicago	Illinois
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	Cedars-Sinai Medical Center	Los Angeles	California
United States	University of California, Los Angeles-Westwood	Los Angeles	California
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	University of California, San Diego	San Diego	California
United States	University of California, Los Angeles-Harbor	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic - MITG

Country where clinical trial is conducted

United States, 

References & Publications (2)

Leuchter AF, Cook IA, Gilmer WS, Marangell LB, Burgoyne KS, Howland RH, Trivedi MH, Zisook S, Jain R, Fava M, Iosifescu D, Greenwald S. Effectiveness of a quantitative electroencephalographic biomarker for predicting differential response or remission wit — View Citation

Leuchter AF, Cook IA, Marangell LB, Gilmer WS, Burgoyne KS, Howland RH, Trivedi MH, Zisook S, Jain R, McCracken JT, Fava M, Iosifescu D, Greenwald S. Comparative effectiveness of biomarkers and clinical indicators for predicting outcomes of SSRI treatment — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1. To confirm prospectively the accuracy of an EEG biomarker as a leading indicator of SSRI antidepressant treatment response;	2. To identify the optimal positive and negative indicators of response to initial treatment with an SSRI; 3. To determine the preferred clinical intervention to perform following an initial negative treatment response indicator;	8 weeks	No
Secondary	1. To confirm prospectively the accuracy of an EEG biomarker as a leading indicator of remission;	2. To explore the relationship between EEG and genetic biomarkers as predictors of treatment response and remission; 3. To determine if certain baseline EEG values or changes early in the course of treatment may predict the emergence of worsening suicidal ideation.	8 weeks	No

External Links

•   MedlinePlus related topics: Depression