EEG Biomarkers for Predicting Response to Antidepressant Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Covidien
ClinicalTrials.gov Identifier:
NCT00289523
First received: February 8, 2006
Last updated: March 6, 2012
Last verified: April 2010
  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 Phase
Major Depressive Disorder
Phase 4

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
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.

Resource links provided by NLM:


Further study details as provided by Covidien:

Primary Outcome Measures:
  • 1. To confirm prospectively the accuracy of an EEG biomarker as a leading indicator of SSRI antidepressant treatment response; [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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;


Secondary Outcome Measures:
  • 1. To confirm prospectively the accuracy of an EEG biomarker as a leading indicator of remission; [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 375
Study Start Date: January 2006
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts
Escitalopram
Bupropion XL
Combination Therapy
Escitalopram and Bupropion XL

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
Sampling Method:   Probability Sample
Study Population

A total of 375 subjects with major depressive disorder (MDD) between the ages of 18 - 75 with no other primary neuropsychiatric illnesses were recruited from the population presenting for ongoing treatment in a primary care clinic, or for depression in a psychiatric clinic at each site.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
University of California, San Diego
San Diego, California, United States, 92161
University of California, Los Angeles-Harbor
Torrance, California, United States, 90509
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
University of Texas, Southwestern
Dallas, Texas, United States, 75235
Baylor University College of Medicine
Houston, Texas, United States, 77030
R/D Clinical Research, Inc.
Lake Jackson, Texas, United States, 77566
Sponsors and Collaborators
Covidien
Investigators
Principal Investigator: Andrew F Leuchter, M.D. University of California, Los Angeles-Westwood
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Covidien
ClinicalTrials.gov Identifier: NCT00289523     History of Changes
Other Study ID Numbers: 227
Study First Received: February 8, 2006
Last Updated: March 6, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Covidien:
Major Depressive Disorder, Depressive Disorder, Unipolar Depression, Antidepressants, Electroencephalography

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antidepressive Agents
Citalopram
Bupropion
Dexetimide
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Antidepressive Agents, Second-Generation
Dopamine Uptake Inhibitors

ClinicalTrials.gov processed this record on August 18, 2014