Evaluation of Use of Brain Activity Monitoring for Evaluation of Depression Treatment

Study Overview
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Brief Summary
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This study evaluates the use of brain activity monitoring for early identification of pharmaceutical treatment efficacy and development of depression deterioration events.

Detailed Description
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The study will be conducted in two arms: In arm I, participants diagnosed with depression. In arm II, healthy participants. Arm I - Participants that need to start or switch their pharmacological antidepressant therapy will be recruited. Their clinical status will be evaluated and their EEG characteristics will be collected. Arm II - Clinical and EEG characteristics of Healthy volunteers will collected on a similar timetable.

Official Title
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Evaluation of Use of Brain Activity Monitoring for Early Identification of Pharmaceutical Treatment Efficacy and Development of Depression Deterioration Events.

Conditions
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Depression

Intervention / Treatment
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* Device: EEG monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant is willing and able to give informed consent for participation in the study. Male or Female, aged 18 -70 years (Adult, Senior) Able and willing to comply with all study requirements. Additional Inclusion Criteria for Arm I Diagnosed with depression Being within 2 days of receiving pharmaceutical treatment for depression for the first time or changing dose or changing type of current pharmaceutical treatment or addition to drug of current pharmaceutical treatment. Additional Inclusion Criteria for Arm II Brief Symptom Inventory (BSI < 2.3). Exclusion Criteria: The participant may not enter the study if ANY of the following apply: Diagnosed with Psychotic disorder. Diagnosed with Central Neurological disorder. A user of recreational or illicit drugs or has had a recent history of drug or alcohol abuse or dependence. Hearing disorder and/or known ear drum impairment. High suicide risk as judged by the research team.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Participants diagnosed with depression.<br>EEG monitoring and evaluation | Device: EEG monitoring<br>* EEG evaluation will be done using two off the shelf EEG devices for research and consumer use. The first one is a device called MindWave by NeuroSky ltd (http://neurosky.com) the second called EPOC by Emotiv ltd (https://emotiv.com/epoc.php). EEG evaluation will be conducted for a total duration of 20 minutes with and without auditory stimulation. The auditory stimulation will be performed using standard headphone or earphones to reduce external noises.<br>|
| Other: Healthy participants.<br>EEG monitoring and evaluation | Device: EEG monitoring<br>* EEG evaluation will be done using two off the shelf EEG devices for research and consumer use. The first one is a device called MindWave by NeuroSky ltd (http://neurosky.com) the second called EPOC by Emotiv ltd (https://emotiv.com/epoc.php). EEG evaluation will be conducted for a total duration of 20 minutes with and without auditory stimulation. The auditory stimulation will be performed using standard headphone or earphones to reduce external noises.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tuning and evaluation of use of EEG analysis of brain prefrontal activity for mental status evaluation. | Outcome measures: optimal EEG device, sampling duration, frequency, and EEG measure dynamics correlation with depression clinical dynamics. | 12 months |