Potential Use Of Brain Network Activation Analysis to Diagnose Major Depression
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Purpose
The investigators are doing this study to find out if they can use electroencephalographic (EEG) recordings, which measure brain waves, to predict response to antidepressant treatments, as well as to distinguish patients who have depression from those who do not. In particular the investigators want to test the usefulness of a new type of analysis of EEG recordings called brain network activation or BNA. BNA allows to identify patterns of activation in brain networks and to track their changes over time.
| Condition |
|---|
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Major Depressive Disorder |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Potential Use Of Brain Network Activation Analysis Using Evoked Response Potentials to Diagnose Major Depression and Assess Response to Antidepressant Treatment |
- Brain Network Analysis group patterns [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]The investogators will make a comparison of Functional networks of brain activity (BNA™) in subjects with MDD and healthy individuals measured using analysis of EEG Event Related Potential (ERP) data [ Time Frame: Baseline, 1 week after the first dose of antidepressant treatment, end of the treatment phase].
- Identify possible predictors of treatment response [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
The investigators will examine the agreement between clinical diagnoses and the change of Brain Network Activation (BNA™)Scores in MDD subjects and healthy controls.
Subjects will undergo clinical diagnostic interviews and a comprehensive neuropsychological and cognitive assessment, and then complete 1 EEG scan of approximately 1 hour. The results of the BNA will be compared to the results of the clinical diagnostic interviews and tests.
| Estimated Enrollment: | 70 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Patients with Major Depressive Disorder
Patients who have Major Depressive Disorder and are taking a Selective Serotonin Re-uptake Inhibitor (SSRI) as part of another study at our clinic.
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Healthy Controls
Patient with no history of significant mental health problems.
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Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
For Patients with Major Depressive Disorder
• Subjects meeting full criteria for the diagnosis of current Major Depressive Disorder (MDD) without psychotic features, as determined by clinical evaluation and Mood Module of structured diagnostic interview (SCID), completed by the study clinician.
For Healthy controls
- Males and females, aged 18-55 years
- Subjects who do not meet full criteria for any of the major psychiatric diagnosis including MDD, bipolar disorder, schizophrenia, substance abuse/dependence, as determined by clinical evaluation and structured diagnostic interview, completed by the study clinician.
For Patients with Major Depressive Disorder
Inclusion Criteria:
• Male and female outpatients, aged 18-55 years
- Subjects meeting full criteria for the diagnosis of current Major Depressive Disorder (MDD) without psychotic features, as determined by clinical evaluation and Mood Module of structured diagnostic interview (SCID), completed by the study clinician.
- HAM-D17 score of 14 or higher
- Able to provide informed consent
- Right handed, normal (corrected) vision and normal hearing
Exclusion Criteria:
• Other primary diagnoses including major depressive disorder with psychotic features, bipolar disorder, schizoaffective disorder, schizophrenia, dementia, attention deficit hyperactivity disorder (ADHD).
- Substance use disorder (abuse or dependence with active use within the last 6 months).
- Significant sensory deficits such as deafness or blindness.
- Severe or unstable medical illness, including history of closed head injury resulting in loss of consciousness, seizure disorder; history of neurological disorders.
- Pregnant or nursing females who are not using an accepted method of contraception (birth control pill, IUD, combination of barrier methods)
- Clinically significant abnormal laboratory values or electrocardiogram For Healthy Controls
Inclusion Criteria:
- Males and females, aged 18-55 years
- Subjects who do not meet full criteria for any of the major psychiatric diagnosis including MDD, bipolar disorder, schizophrenia, substance abuse/dependence, attention deficit hyperactivity disorder (ADHD), as determined by clinical evaluation and structured diagnostic interview, completed by the study clinician.
- Right handed, normal (corrected) vision and normal hearing
Exclusion Criteria:
- Any current primary psychiatric, or medical condition determined to be clinically significant.
- Current use of psychotropics or any medication with clinically significant central nervous system effects.
Contacts and Locations| United States, Massachusetts | |
| Depression Clinical and Research Program | |
| Boston, Massachusetts, United States, 02114 | |
| Principal Investigator: | Cristina Cusin, MD | Massachusetts General Hospital |
| Principal Investigator: | Ottavio Vitolo, MD | Massachusetts General Hospital |
More Information
No publications provided
| Responsible Party: | Cristina Cusin, MD, Principal Investigator, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT01579942 History of Changes |
| Other Study ID Numbers: | 2011P000200 |
| Study First Received: | April 11, 2012 |
| Last Updated: | December 13, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Massachusetts General Hospital:
|
EEG Biomarker Major Depressive Disorder Healthy Control |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Depressive Disorder, Major Behavioral Symptoms Mood Disorders Mental Disorders Serotonin Uptake Inhibitors |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Serotonin Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 21, 2013