Recruiting

NIRSIT

Sponsor:

UCLA

Code:

NCT04061148

Conditions

Major Depressive Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

NIRSIT

Study Details

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.

Conditions

Major Depressive Disorder

Study ID

NCT04061148

Start date

Jan 4, 2019

Status verified date

Sep, 2026

Completion date

Dec 30, 2030

Anticipated

Primary completion date

Dec 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • All subjects who sign informed consent.
  • Controls: Volunteers over 18 years of age who are not depressed.
  • Patients over 18 years of age with a diagnosis of Major Depressive Disorder, receiving clinical therapy at SFVAMC.

Exclusion Criteria:

  • Subjects who cannot sign informed consent.
  • Exclusion criteria for control subjects: 1.Depression 2.Anxiety, psychotic, substance abuse, mood and personality disorders 3.Major neurocognitive disorders such as Alzheimer's disease and other dementias 4.Neurologic disorders with anatomic lesions including traumatic brain injury, stroke, tumor and arteriovenous malformation
  • Exclusion criteria for depressed patients: 1.Psychotic disorders like schizophrenia 2.Major neurocognitive disorders such as Alzheimer's disease and other dementias 3.Neurologic disorders with anatomic lesions including traumatic brain injury, stroke, tumor and arteriovenous malformation 4.Not receiving clinical therapy for depression at SFVAMC'

Study Design

Enrollment

90 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

other: Non-Depressed Controls

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.

active comparator: Depressed Patients

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.

Interventions

NIRSIT

NIRSIT is a device that utilizes Near Infrared Spectroscopy to provide a non-invasive measurement of frontal lobe blood oxygenation over time.

Primary outcome measure

  • Change in Frontal Oxyhemoglobin concentration before initiation of treatment for MDD [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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. ]

Central Contacts and Locations

Central contacts

Anusha Badathala, MBBS

4152214810Anusha.Badathala@ncire.org

Arthur Wallace, MD, PhD

4152214810art.wallace@va.gov

Locations

San Francisco Veterans Affairs Medical Center

Recruiting

San Francisco, California, United States, 94121

More Information

Sponsor

University of California, San Francisco

Last update posted

Sep 11, 2026

Last verified

Sep, 2026

Keywords

  • Near Infrared Spectroscopy
  • Depression
  • NIRS
  • Major Depressive Disorder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-12. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-09-11.