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| Tracking Information | |||||
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| First Received Date ICMJE | February 8, 2006 | ||||
| Last Updated Date | March 30, 2007 | ||||
| Start Date ICMJE | January 2006 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00289523 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | EEG Biomarkers for Predicting Response to Antidepressant Therapy | ||||
| Official Title ICMJE | 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:
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| 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. |
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| Study Phase | Phase IV | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Screening, Longitudinal, Defined Population, Prospective Study | ||||
| Condition ICMJE | Major Depressive Disorder | ||||
| Intervention ICMJE | Drug: Escitalopram, Bupropion XL | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | Cook IA, Leuchter AF, Morgan ML, Stubbeman W, Siegman B, Abrams M. Changes in prefrontal activity characterize clinical response in SSRI nonresponders: a pilot study. J Psychiatr Res. 2005 Sep;39(5):461-6. | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 375 | ||||
| Completion Date | June 2007 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 21 Years to 75 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00289523 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 227 | ||||
| Study Sponsor ICMJE | Aspect Medical Systems | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Aspect Medical Systems | ||||
| Verification Date | February 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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