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Sponsored by: |
Aspect Medical Systems |
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Information provided by: | Aspect Medical Systems |
ClinicalTrials.gov Identifier: | NCT00289523 |
The purpose of this study is to evaluate the potential early EEG predictors of an individual’s response to treatment with antidepressant medications.
Objectives:
Condition | Intervention | Phase |
---|---|---|
Major Depressive Disorder |
Drug: Escitalopram, Bupropion XL |
Phase IV |
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. |
Estimated Enrollment: | 375 |
Study Start Date: | January 2006 |
Estimated Study Completion Date: | June 2007 |
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.
Ages Eligible for Study: | 21 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Principal Investigator: | Andrew F Leuchter, M.D. | University of California, Los Angeles-Westwood |
Study ID Numbers: | 227 |
Study First Received: | February 8, 2006 |
Last Updated: | March 30, 2007 |
ClinicalTrials.gov Identifier: | NCT00289523 History of Changes |
Health Authority: | United States: Institutional Review Board |
Major Depressive Disorder, Depressive Disorder, Unipolar Depression, Antidepressants, Electroencephalography |
Dopamine Uptake Inhibitors Neurotransmitter Agents Depression Cholinergic Antagonists Psychotropic Drugs Depressive Disorder, Major Cholinergic Agents Depressive Disorder Serotonin Uptake Inhibitors Citalopram Serotonin |
Behavioral Symptoms Muscarinic Antagonists Dopamine Mental Disorders Bupropion Mood Disorders Dopamine Agents Peripheral Nervous System Agents Antidepressive Agents, Second-Generation Dexetimide Antidepressive Agents |
Dopamine Uptake Inhibitors Parasympatholytics Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Cholinergic Antagonists Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Physiological Effects of Drugs Psychotropic Drugs Antiparkinson Agents Depressive Disorder, Major Cholinergic Agents Mental Disorders Therapeutic Uses Antidepressive Agents, Second-Generation |
Dexetimide Antidepressive Agents Depression Depressive Disorder Serotonin Uptake Inhibitors Citalopram Pharmacologic Actions Behavioral Symptoms Muscarinic Antagonists Serotonin Agents Autonomic Agents Bupropion Mood Disorders Dopamine Agents Peripheral Nervous System Agents |