Objective Evaluation of Depression Using Sleep EEG

The purpose of study is to collect and analyze human sleeping brainwave data, to better
understand depression in humans.

First visit:

- Informed consent procedures, including explanation of research background, purpose,
details of implementation, and study benefits and risks

- Interview with questionnaires (MINI International Psychiatric Interview, Hamilton Rating
Scale for Depression, Beck Depression Inventory, Patient Health Questionnaire for
Depression [PHQ-9]), physical examination.

- Urine drug sample for screening of controlled substances.

- Inform participants that those qualifying will be informed whether or not to proceed
with second visit

Second visit:

- Explanation of EEG measurement (placement of two electrodes, one on the forehead and one
behind the ear)

- Sleep diary provided for participant to complete at home for each night until third
visit

- Distribution of EEG devices for home use

- EEG measurement conducted at participant's residence for three nights of stable
sleep-wake cycles

Third visit:

- Collect EEG devices and check completeness of downloaded data

Inclusion Criteria:

Individuals with Untreated Depression:

- 16 men and 16 women aged from 30 to 59 years, with an approximate ethnic balance of 10
Asian, 3 White and 3 other ethnicity for each gender, whom are diagnosed with Major
Depressive Disorder by a psychiatric specialist of this research according to MINI
screening and DSM-5 criteria, and defined as a score of 15 or higher on the
clinician-administered Hamilton Rating Scale for Depression, Beck Depression Inventory, and
Patient Health Questionnaire for Depression (PHQ-9).

Healthy Participants:

- 16 men and 16 women age-, ethnic-, and gender-matched healthy participants to the cohort
with untreated depression, with absence of mental disorders, including but not limited to
depression and sleep disorders, by a psychiatric specialist according to MINI screening and
DSM-5 criteria, and negative Hamilton Rating Scale for Depression, Beck Depression
Inventory, and Patient Health Questionnaire for Depression (PHQ-9).

Exclusion Criteria:

Participants corresponding to any of the following conditions are considered ineligible for
the trial.

- Diagnosed with epilepsy or other organic brain disorder.

- Medical conditions resulting in depressive symptoms such as hypothyroidism, Cushing's
disease, systemic lupus erythematosus; neurological conditions resulting in depressive
symptoms such as Parkinson's disease, Huntington's disease, multiple sclerosis

- Patients with suspected sleep apnea, based on symptoms and a BMI of 30 or greater

- Prescribed interferon regularly with stimulants, opioid drugs (Ritalin, Opioid, etc.)
and steroids

- Repetitive thoughts of death, current thoughts about suicide, suicide attempts, or a
suicide plan

- Tested positive to controlled substance use by a urine drug screening before
commencement of testing

- Current or past drug or alcohol dependence

- Shift work or rotating work schedule

- Nursing, pregnant or planning to become pregnant

- Participating in other clinical trials