Major Depressive DisorderNCT00289523
EEG Biomarkers for Predicting Response to Antidepressant Therapy
An observational study of Major Depressive Disorder, run by Medtronic - MITG at 10 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Major Depressive Disorder
- How many people
- 375 participants
- Where
- 10 sitesUnited States
- Study dates
- Jan 2006to Jul 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Subject has diagnosis of Major Depressive Disorder
Who cannot join
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Northwestern University
Chicago, Illinois, 60611
University of Texas, Southwestern
Dallas, Texas, 75235
Baylor University College of Medicine
Houston, Texas, 77030
R/D Clinical Research, Inc.
Lake Jackson, Texas, 77566
University of California, Los Angeles-Westwood
Los Angeles, California, 90024
Cedars-Sinai Medical Center
Los Angeles, California, 90048
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
University of California, San Diego
San Diego, California, 92161
University of California, Los Angeles-Harbor
Torrance, California, 90509
About this 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.
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
Read the 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.
- Conditions
- Major Depressive Disorder
- Keywords
- Major Depressive Disorder, Depressive Disorder, Unipolar Depression, Antidepressants, Electroencephalography
- Medical subject headings
- Depressive Disorder, Major, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Escitalopram | Not described | |
| Bupropion XL | Not described | |
| Combination Therapy | Escitalopram and Bupropion XL |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. To confirm prospectively the accuracy of an EEG biomarker as a leading indicator of SSRI antidepressant treatment response;
- 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;
Measured: 8 weeks
Secondary outcomes (1)
1. To confirm prospectively the accuracy of an EEG biomarker as a leading indicator of remission;
- 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2006 (estimated)
- Study startJan 2006
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Medtronic - MITGThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 375 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew F Leuchter, M.D., Principal investigator, University of California, Los Angeles-Westwood
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00289523
- Sponsor's protocol ID
- 227
- Status last verified
- Apr 2010
- First submitted
- 8 Feb 2006
- Last updated
- 7 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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 in Major Depressive Disorder: results of the BRITE-MD study. Psychiatry Res. 2009 Sep 30;169(2):124-31. doi: 10.1016/j.psychres.2009.06.004. Epub 2009 Aug 27.
PubMed 19712979Leuchter 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 with escitalopram and bupropion in major depressive disorder. Psychiatry Res. 2009 Sep 30;169(2):132-8. doi: 10.1016/j.psychres.2009.04.004. Epub 2009 Aug 26.
PubMed 19709754Cook IA, Hunter AM, Gilmer WS, Iosifescu DV, Zisook S, Burgoyne KS, Howland RH, Trivedi MH, Jain R, Greenwald S, Leuchter AF. Quantitative electroencephalogram biomarkers for predicting likelihood and speed of achieving sustained remission in major depression: a report from the biomarkers for rapid identification of treatment effectiveness in major depression (BRITE-MD) trial. J Clin Psychiatry. 2013 Jan;74(1):51-6. doi: 10.4088/JCP.10m06813.
PubMed 23419226
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00289523
- Acronym / sponsor ID
- 227
- Conditions
- Major Depressive Disorder
- Keywords
- Major Depressive Disorder, Depressive Disorder, Unipolar Depression, Antidepressants, Electroencephalography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 375 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 10 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Escitalopram | – | – |
| Bupropion XL | – | – |
| Combination Therapy | – | –Escitalopram and Bupropion XL |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Subject has diagnosis of Major Depressive Disorder
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
1. To confirm prospectively the accuracy of an EEG biomarker as a leading indicator of SSRI antidepressant treatment response;
Time frame: 8 weeks
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;
1 secondary outcome
1. To confirm prospectively the accuracy of an EEG biomarker as a leading indicator of remission;
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2012.
- Results publication: PubMed 19712979Leuchter 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 in Major Depressive Disorder: results of the BRITE-MD study. Psychiatry Res. 2009 Sep 30;169(2):124-31. doi: 10.1016/j.psychres.2009.06.004. Epub 2009 Aug 27.
- Results publication: PubMed 19709754Leuchter 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 with escitalopram and bupropion in major depressive disorder. Psychiatry Res. 2009 Sep 30;169(2):132-8. doi: 10.1016/j.psychres.2009.04.004. Epub 2009 Aug 26.
- Derived from this study: PubMed 23419226Cook IA, Hunter AM, Gilmer WS, Iosifescu DV, Zisook S, Burgoyne KS, Howland RH, Trivedi MH, Jain R, Greenwald S, Leuchter AF. Quantitative electroencephalogram biomarkers for predicting likelihood and speed of achieving sustained remission in major depression: a report from the biomarkers for rapid identification of treatment effectiveness in major depression (BRITE-MD) trial. J Clin Psychiatry. 2013 Jan;74(1):51-6. doi: 10.4088/JCP.10m06813.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew F Leuchter, M.D. principal investigator
University of California, Los Angeles-Westwood
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder, run by Medtronic - MITG at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. To confirm prospectively the accuracy of an EEG biomarker as a leading indicator of SSRI antidepressant treatment response; (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00289523, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2012.