Objective Evaluation of Depression Using Sleep EEG

Completed · Not applicable

Conditions studied: Depression

In brief

The purpose of this study is to test the ability of a brainwave measurement device (SLEEPSCOPE) in identifying and assisting in the diagnosis of depression. The brainwave data from individuals with untreated depression and healthy participants will be collected and analyzed. The ability to obtain brainwave data from individuals in their homes while they're sleeping would represent a significant advance in depression research.

Key facts

Study ID

NCT03133013

Run by

Stanford University

People needed

24

Starts

2017-05-01

Expected to finish

2019-05-31

Last updated by the study team

2019-12-12

Who can join

Age: 30 and older, up to 59. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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

Where it is running

• Stanford Sleep Medicine Center — Redwood City, California, United States

Full record on ClinicalTrials.gov

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