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

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?

Research shows that functional near-infrared spectroscopy (fNIRS) can help diagnose and predict treatment responses in major depressive disorder by monitoring brain activity, especially in the prefrontal regions, which are linked to mood regulation.12345

Is Near Infrared Spectroscopy (NIRS) safe for use in humans?

The research articles reviewed do not provide specific safety data for Near Infrared Spectroscopy (NIRS) in humans, focusing instead on its diagnostic potential for conditions like major depressive disorder and suicidality.23567

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

AW

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

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

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)

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Non-Depressed ControlsExperimental Treatment1 Intervention
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.
Group II: Depressed PatientsActive Control1 Intervention
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.

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+

Findings from Research

In a 12-week study involving 11 medication-naïve participants with major depressive disorder (MDD), all subjects achieved remission after treatment with sertraline, indicating its efficacy as an antidepressant.
The study found a significant negative correlation between oxygenated hemoglobin levels in the prefrontal region and changes in depression scores, suggesting that these hemodynamic changes could serve as potential biological markers for predicting treatment response in MDD.
Brain functional alterations observed 4-weekly in major depressive disorder following antidepressant treatment.Yamagata, B., Yamanaka, K., Takei, Y., et al.[2020]
Functional near-infrared spectroscopy (fNIRS) has shown potential in differentiating between individuals with major depressive disorder (MDD) and healthy individuals by detecting reduced cerebral hemodynamic changes, based on a review of 64 studies.
fNIRS signals correlate with specific symptoms of depression and can effectively monitor treatment responses, suggesting its utility as a diagnostic and predictive tool for MDD.
Diagnostic and Predictive Applications of Functional Near-Infrared Spectroscopy for Major Depressive Disorder: A Systematic Review.Ho, CSH., Lim, LJH., Lim, AQ., et al.[2022]
In a study involving 40 first-episode medication-naïve depression patients (FMD) and 53 recurrent major depression patients (RMD), both groups showed lower oxygenated hemoglobin concentration ([oxy-Hb]) in the frontal and temporal lobes compared to healthy controls, indicating impaired brain function during cognitive tasks.
Patients with RMD exhibited significantly lower hemodynamic responses in specific brain areas (right dorsolateral prefrontal cortex and dorsal frontal pole cortex) compared to FMD patients, suggesting that neurofunctional differences may relate to the stage of major depressive disorder (MDD).
The fNIRS evaluation of frontal and temporal lobe cortical activation in Chinese first-episode medication-naïve and recurrent depression during a verbal fluency task.Yang, T., Wang, H., Dai, H., et al.[2023]

References

Brain functional alterations observed 4-weekly in major depressive disorder following antidepressant treatment. [2020]
Diagnostic and Predictive Applications of Functional Near-Infrared Spectroscopy for Major Depressive Disorder: A Systematic Review. [2022]
The fNIRS evaluation of frontal and temporal lobe cortical activation in Chinese first-episode medication-naïve and recurrent depression during a verbal fluency task. [2023]
Alterations in prefrontal cortical activity in the course of treatment for late-life depression as assessed on near-infrared spectroscopy. [2019]
Near-infrared spectroscopy for examination of prefrontal activation during cognitive tasks in patients with major depressive disorder: a meta-analysis of observational studies. [2015]
Clinical Utility of Functional Near-Infrared Spectroscopy for Assessment and Prediction of Suicidality: A Systematic Review. [2021]
Impaired Oxygenation of the Prefrontal Cortex During Verbal Fluency Task in Young Adults With Major Depressive Disorder and Suicidality: A Functional Near-Infrared Spectroscopy Study. [2022]
[Establishing biological markers for diagnosis and treatment of depression: possible availability of PET, NIRS, and DST]. [2018]
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