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 — DEVICENIRSIT 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 ControlsVolunteers 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 PatientsPatients 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
- Anusha Badathala, MBBS4152214810
- Arthur Wallace, MD, PhD4152214810
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| San Francisco Veterans Affairs Medical Center | San Francisco | California | 94121 | Arthur Wallace, MD, PhD |
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