NIRSIT / Major Depressive Disorder · Interventional Study

Near Infrared Spectroscopy (NIRS) for Assessment of Depression

ClinicalTrials.gov · September 11, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a registry record for a recruiting interventional study using near-infrared spectroscopy (NIRS) to measure frontal hemoglobin changes in patients with major depressive disorder during cognitive tasks. The study aims to develop a diagnostic protocol but has not yet reported results; it measures surrogate neurophysiological markers rather than clinical outcomes.

What was studied

Interventional, Non Randomized, Parallel, Open label, Diagnostic purpose. Major Depressive Disorder; age from 18 Years; accepts healthy volunteers. Intervention: Non-Depressed Controls. Compared with: Depressed Patients — Active Comparator. n = 90. 1 site: United States.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a recruiting interventional study with surrogate neurophysiological endpoints (hemoglobin concentration changes) in a small planned sample, designed to develop and validate a diagnostic protocol rather than test clinical efficacy.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Change in Frontal Oxyhemoglobin concentration before initiation of treatment for MDD (assessed at Each measurement is over 10 to 15 mins long, taken during the performance of VF…); Change in Frontal Oxyhemoglobin concentration 3 weeks after initiation of treatment for MDD (assessed at Each measurement is over 10 to 15 mins long, taken during the performance of VF…); Change in Frontal Oxyhemoglobin concentration 6 weeks after initiation of treatment for MDD (assessed at Each measurement is over 10 to 15 mins long, taken during the performance of VF…); Change in Fronta…

DesignInterventional, Non Randomized, Parallel, Open label, Diagnostic purpose

PopulationMajor Depressive Disorder; age from 18 Years; accepts healthy volunteers

Sample size90

InterventionNon-Depressed Controls

ComparatorDepressed Patients — Active Comparator

Setting1 site: United States

Reported figures

Quoted from the source exactly as published.

Planned sample size90

Primary outcome measure 1Change in Frontal Oxyhemoglobin concentration before initiation of treatment for MDD

Primary outcome measure 2Change in Frontal Oxyhemoglobin concentration 3 weeks after initiation of treatment for MDD

Primary outcome measure 3Change in Frontal Oxyhemoglobin concentration 6 weeks after initiation of treatment for MDD

Primary outcome measure 4Change in Frontal Deoxyhemoglobin concentration before initiation of treatment for MDD

Primary outcome measure 5Change in Frontal Deoxyhemoglobin concentration 3 weeks after initiation of treatment for MDD

Primary outcome measure 6Change in Frontal Deoxyhemoglobin concentration 6 weeks after initiation of treatment for MDD

Measurement duration per session10 to 15 minutes

Caveats

This is a registry record only; no results are posted and the study is still recruiting.
Primary outcomes are surrogate neurophysiological markers (hemoglobin concentration changes during cognitive tasks), not validated clinical depression severity scales or treatment response.
No comparator arm details, blinding strategy, or randomisation method reported in registry record.
Phase designation not specified; statistical power calculation and primary hypothesis threshold not reported.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

limited

Interventional device study with repeated measures; phase not specified in registry.

Directness

limited

Primary outcomes are surrogate markers (hemoglobin concentration), not clinical depression severity or treatment response.

Consistency

insufficient

Registry record only; no results posted; consistency cannot be assessed.

Risk of bias

insufficient

Blinding, allocation concealment, and comparator details not described in registry record.

Sample adequacy

limited

Planned enrollment 90 participants; study still recruiting with no power calculation reported.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT04061148). This is a study registration, not published results. Lead sponsor: University of California, San Francisco. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 90 participants (ESTIMATED). Conditions: Major Depressive Disorder. Interventions: DEVICE: NIRSIT. Primary outcome measures: Change in Frontal Oxyhemoglobin concentration before initiation of treatment for MDD , 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.; Change in Frontal Oxyhemoglobin concentration 3 weeks after initiation of treatment for MDD , Each measurement is over 10 to 15 mins long, taken during the performance of VFT and CHR, 3 weeks after initiation of treatment for MDD.; Change in Frontal Oxyhemoglobin concentration 6 weeks after initiation of treatment for MDD , Each measurement is over 10 to 15 mins long, taken during the performance of VFT and CHR, 6 weeks after initiation of treatment for MDD.; Change in Frontal Deoxyhemoglobin concentration before initiation of treatment for MDD , 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.; Change in Frontal Deoxyhemoglobin concentration 3 weeks after initiation of treatment for MDD , Each measurement is over 10 to 15 mins long, taken during the performance of VFT and CHR, 3 weeks after initiation of treatment for MDD.; Change in Frontal Deoxyhemoglobin concentration 6 weeks after initiation of treatment for MDD , Each measurement is over 10 to 15 mins long, taken during the performance of VFT and CHR, 6 weeks after initiation of treatment for MDD.. Brief summary: 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

University of California, San FrancisNIRSITNCT04061148Major Depressive Disorder