NIRS for Depression
(NIRSIT Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify whether you need to stop taking your current medications. However, since it involves patients already receiving clinical therapy for depression, it seems likely that you can continue your current treatment.
What data supports the effectiveness of the treatment NIRSIT for depression?
Is Near Infrared Spectroscopy (NIRS) safe for use in humans?
How is NIRS treatment different from other depression treatments?
NIRS (Near-Infrared Spectroscopy) is unique because it is a noninvasive method that measures brain activity by assessing blood flow in the brain, which can help in diagnosing depression and predicting treatment responses. Unlike traditional treatments that focus on medication or therapy, NIRS provides real-time insights into brain function, potentially offering a new way to understand and manage depression.12358
What is the purpose of this trial?
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.
Research Team
Arthur Wallace, MD, PhD
Principal Investigator
San Francisco Veterans Affairs Medical Center
Eligibility Criteria
This trial is for adults over 18 who are either not depressed (controls) or diagnosed with Major Depressive Disorder and currently receiving treatment at SFVAMC. Participants must be able to give informed consent. Those with anxiety, psychotic disorders, substance abuse issues, major neurocognitive disorders like Alzheimer's, or neurological conditions with lesions are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Initial assessment of depressive symptoms using HDRS, BDI, and PHQ-9, and cognitive assessment prior to NIRSIT testing
NIRSIT Testing
Participants undergo NIRSIT testing to measure frontal blood oxygenation, with repeated sessions up to five times
Follow-up
Participants are monitored for changes in depression scores and blood oxygenation levels after NIRSIT testing
Treatment Details
Interventions
- NIRSIT
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Francisco
Lead Sponsor
Obelab Inc.
Collaborator
San Francisco Veterans Affairs Medical Center
Collaborator
OBELAB, Inc.
Industry Sponsor