90 Participants Needed

NIRS for Depression

(NIRSIT Trial)

AB
AW
Overseen ByArthur Wallace, MD, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of California, San Francisco
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

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?

AW

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

All subjects who sign informed consent

Exclusion Criteria

I do not have depression, anxiety, major neurocognitive disorders like Alzheimer's, or neurologic disorders with brain lesions.
I do not have schizophrenia, Alzheimer's, brain injuries, or untreated depression.
I am unable to sign the informed consent form.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Baseline Assessment

Initial assessment of depressive symptoms using HDRS, BDI, and PHQ-9, and cognitive assessment prior to NIRSIT testing

1 day
1 visit (in-person)

NIRSIT Testing

Participants undergo NIRSIT testing to measure frontal blood oxygenation, with repeated sessions up to five times

9-15 weeks
Up to 5 visits (in-person)

Follow-up

Participants are monitored for changes in depression scores and blood oxygenation levels after NIRSIT testing

6 weeks
3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • NIRSIT
Trial Overview The trial is testing a new diagnostic protocol using NIRSIT technology to distinguish symptoms and severity of depression in patients compared to non-depressed individuals through up to five visits per subject.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Non-Depressed ControlsExperimental Treatment1 Intervention
Group II: Depressed PatientsActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials
2,636
Recruited
19,080,000+

Obelab Inc.

Collaborator

Trials
1
Recruited
90+

San Francisco Veterans Affairs Medical Center

Collaborator

Trials
52
Recruited
211,000+

OBELAB, Inc.

Industry Sponsor

Trials
2
Recruited
130+

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/40226684/
Functional Near-Infrared Spectroscopy-Based Computer ...In this study, we propose a novel deep learning framework based on a convolutional neural network (CNN) for the fNIRS-based CAD of MDD with high accuracy.
Application of functional near-infrared spectroscopy and ...This study investigates whether functional near-infrared spectroscopy (fNIRS) and clinical assessment information can predict treatment response ...
Functional near-infrared spectroscopy (fNIRS) in patients ...The coexistence of GAD and MDD results in reduced treatment outcomes, increased disability and suicidal ideation, and impaired quality of life compared to MDD ...
Near Infrared Spectroscopy (NIRS) for Assessment of ...Develop a NIRSIT testing protocol that can be administered in the diagnostic setting and reliably distinguishes the symptoms and severity of depression, ...
5.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/40071372/
Application of Near-Infrared Spectroscopy in Early ...This study underscores the potential of NIRS as a non-invasive, objective tool for early detection and monitoring of treatment efficacy in MDD.
Functional Near-Infrared Spectroscopy-Based Computer ...Diagnostic and predictive applications of functional near-infrared spectroscopy for major depressive disorder: a systematic review.
Functional near-infrared spectroscopy-based diagnosis ...Our study utilizes functional near-infrared spectroscopy (fNIRS) and machine learning to accurately classify mild and severe depression.
A functional near-infrared spectroscopy (fNIRS) studyThis study focuses on the characteristics and neural mechanisms of WM in individuals with depressive tendencies.
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