Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
24 participants
INTERVENTIONAL
2017-05-01
2019-05-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Individuals with Untreated Depression
32 participants diagnosed with Major Depressive Disorder by a psychiatric specialist of this research according to MINI screening and Diagnostic and Statistical Manual (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). The participants will be attached to the SLEEPSCOPE device.
SLEEPSCOPE
Brainwave measurement device which is connected to the participant by an electrode attached to the forehead and another electrode behind one ear
Healthy Participants
32 healthy participants with absence of mental disorders, including but not limited to depression and sleep disorders, by a psychiatric specialist according to MINI screening and Diagnostic and Statistical Manual (DSM-5) criteria, and negative Hamilton Rating Scale for Depression, Beck Depression Inventory, and Patient Health Questionnaire for Depression (PHQ-9). The participants will be attached to the SLEEPSCOPE device.
SLEEPSCOPE
Brainwave measurement device which is connected to the participant by an electrode attached to the forehead and another electrode behind one ear
Interventions
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SLEEPSCOPE
Brainwave measurement device which is connected to the participant by an electrode attached to the forehead and another electrode behind one ear
Eligibility Criteria
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Inclusion Criteria
\- 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
* 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
30 Years
59 Years
ALL
Yes
Sponsors
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Stanford University
OTHER
Responsible Party
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Clete A. Kushida
Professor
Principal Investigators
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Clete A Kushida, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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Stanford Sleep Medicine Center
Redwood City, California, United States
Countries
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Other Identifiers
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41103
Identifier Type: -
Identifier Source: org_study_id