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The study was ultimately not funded by the sponsor. No subjects were enrolled.
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| Name | Class |
|---|---|
| ElMindA Ltd | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. | ||
| Healthy Controls | Patient with no history of significant mental health problems. |
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| 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 |
| 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. |
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For Patients with Major Depressive Disorder
Inclusion Criteria:
• Male and female outpatients, aged 18-55 years
Exclusion Criteria:
• Other primary diagnoses including major depressive disorder with psychotic features, bipolar disorder, schizoaffective disorder, schizophrenia, dementia, attention deficit hyperactivity disorder (ADHD).
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Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Cristina Cusin, MD | Massachusetts General Hospital | Principal Investigator |
| Ottavio Vitolo, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Depression Clinical and Research Program | Boston | Massachusetts | 02114 | United States |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| 8 weeks |