Major Depressive Disorder
Conditions
Keywords
EEG, Biomarker, Major Depressive Disorder, Healthy Control
Brief summary
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.
Interventions
None listed
Sponsors
ElMindA Ltd
Massachusetts General Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brain Network Analysis group patterns | 8 weeks | 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 \[ Time Frame: Baseline, 1 week after the first dose of antidepressant treatment, end of the treatment phase\]. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Identify possible predictors of treatment response | 8 weeks | 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. |
Countries
United States
Outcome results
None listed