Near Infrared Spectroscopy (NIRS) for Assessment of Depression

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT04061148
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • NIRSIT — DEVICE
    NIRSIT is a device that utilizes Near Infrared Spectroscopy to provide a non-invasive measurement of frontal lobe blood oxygenation over time.

Study Details

Develop a NIRSIT testing protocol that can be administered in the diagnostic setting and reliably distinguishes the symptoms and severity of depression, with the help of repeated measure (up to five visits per subject) comparison of patients being treated for Major Depressive Disorder with control, non-depressed subjects.

Key Dates

Start date
Jan 4, 2019
Status verified
Mar 2025
Primary completion
Dec 30, 2027
Completion
Dec 30, 2027

Study Design

Enrollment
90 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Other: Non-Depressed Controls
    Volunteers who have screened by a clinical psychiatrist, to exclude depression and other major psychiatric and neurocognitive disorders. They will undergo NIRSIT testing to measure frontal blood oxygenation up to 3 times, with an interval of 3 weeks between each measurement.
  • Active Comparator: Depressed Patients
    Patients diagnosed with Major Depressive Disorder by a clinical psychiatrist. They will undergo NIRSIT testing to measure frontal blood oxygenation up to 5 times, with an interval of 3 weeks between each measurement, over the course of their clinical therapy for Major Depressive Disorder.

Primary Outcome Measure

Change in Frontal Oxyhemoglobin concentration before initiation of treatment for MDD [ Time Frame: Each measurement is over 10 to 15 mins long, taken during the performance of VFT and CHR, on the day of initiation of treatment for MDD, but before the treatment is given. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
San Francisco Veterans Affairs Medical CenterSan FranciscoCalifornia94121
Arthur Wallace, MD, PhD

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