Potential Use Of Brain Network Activation Analysis to Diagnose Major Depression

Study Overview
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Brief Summary
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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.

Official Title
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Potential Use Of Brain Network Activation Analysis Using Evoked Response Potentials to Diagnose Major Depression and Assess Response to Antidepressant Treatment

Conditions
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Major Depressive Disorder

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with Major Depressive Disorder<br>Patients who have Major Depressive Disorder and are taking a Selective Serotonin Re-uptake Inhibitor (SSRI) as part of another study at our clinic. | |
| Healthy Controls<br>Patient with no history of significant mental health problems. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain Network Analysis group patterns | 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]. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify possible predictors of treatment response | 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. | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EEG, Biomarker, Major Depressive Disorder, Healthy Control