NIRS for Depression
(NIRSIT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new approach called NIRSIT, which measures blood oxygen levels in the brain to better diagnose and understand depression. The goal is to determine if this method can accurately identify the symptoms and severity of Major Depressive Disorder. The trial includes two groups: one with individuals who have depression and another with non-depressed individuals. Participants should either have a diagnosis of Major Depressive Disorder and be receiving treatment, or have no depression or other major mental health issues. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance depression diagnosis and treatment.
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 prior data suggests that the NIRSIT testing protocol is safe for diagnosing depression?
Research has shown that NIRSIT, a type of brain scan, is generally safe for people. Studies indicate it can help monitor brain activity linked to depression. These studies report no harmful side effects from using NIRSIT. It measures brain oxygen levels to understand emotions and stress, aiding in diagnosing depression. This technology doesn't require medication or invasive procedures. Instead, it uses light to scan the brain, similar to how a pulse oximeter measures blood oxygen. Overall, past research has noted that NIRSIT is well-tolerated, with no major safety concerns.12345
Why are researchers excited about this trial?
Researchers are excited about NIRSIT for depression because it offers a unique approach by using near-infrared spectroscopy to measure brain activity. Unlike typical treatments like antidepressants and therapy, which focus on altering chemical balances or behavior, NIRSIT targets brain blood oxygenation, providing insights into brain function in real-time. This method could lead to more personalized treatment plans by identifying how depressed and non-depressed brains differ in their oxygen usage, potentially enhancing the effectiveness of existing therapies.
What evidence suggests that the NIRSIT protocol is effective for diagnosing depression?
Research shows that Near-Infrared Spectroscopy (NIRS) can help diagnose and monitor Major Depressive Disorder (MDD). Studies have found that NIRS effectively measures brain activity linked to depression symptoms. In this trial, participants will undergo NIRSIT testing to measure frontal blood oxygenation. This tool, called functional NIRS, has predicted how well patients might respond to depression treatment. It is non-invasive, meaning it doesn't involve surgery or entering the body, and it provides clear data on brain function. Early results suggest that NIRS could become a reliable way to assess and track the severity of depression.23678
Who Is on the Research Team?
Arthur Wallace, MD, PhD
Principal Investigator
San Francisco Veterans Affairs Medical Center
Are You a Good Fit for This Trial?
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 for a Trial Participant
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
What Are the Treatments Tested in This Trial?
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