Near Infrared Spectroscopy (NIRS) for Assessment of Depression

NCT04061148 | Recruiting FDA Device

• 1 other identifier: 17-22188
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Keywords

Near Infrared Spectroscopy; Depression; NIRS; Major Depressive Disorder

Outcome Measures

Primary Outcomes (6)

• Change in Frontal Oxyhemoglobin concentration before initiation of treatment for MDD

  Change in Oxyhemoglobin concentration in frontal blood from the baseline during the performance of Verbal Fluency Task (VFT) and Cartoon humor reaction task (CHR) by the subject.

  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

  Change in Oxyhemoglobin concentration in frontal blood from the baseline during the performance of Verbal Fluency Task (VFT) and Cartoon humor reaction task (CHR) by the subject.

  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

  Change in Oxyhemoglobin concentration in frontal blood from the baseline during the performance of Verbal Fluency Task (VFT) and Cartoon humor reaction task (CHR) by the subject.

  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

  Change in Deoxyhemoglobin concentration in frontal blood from the baseline during the performance of Verbal Fluency Task and Cartoon humor reaction task by the subject.

  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

  Change in Deoxyhemoglobin concentration in frontal blood from the baseline during the performance of Verbal Fluency Task and Cartoon humor reaction task by the subject.

  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

  Change in Deoxyhemoglobin concentration in frontal blood from the baseline during the performance of Verbal Fluency Task and Cartoon humor reaction task by the subject.

  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.

Secondary Outcomes (3)

• Hamilton Depression Rating Scale (HAM-D) Score

  HAM-D is administered before each of the three NIRS measurement sessions; on the day of initiation of treatment for MDD, but before the treatment is given; 3 weeks after initiation of treatment and 6 weeks after the initiation of treatment.

• Beck's Depression Inventory - II (BDI-II) Scores

  BDI-II is administered before each of the three NIRS measurement sessions; on the day of initiation of treatment for MDD, but before the treatment is given; 3 weeks after initiation of treatment and 6 weeks after the initiation of treatment.

• Patient Health Questionnaire-9 (PHQ-9) Scores

  PHQ-9 is administered before each of the three NIRS measurement sessions; on the day of initiation of treatment for MDD, but before the treatment is given; 3 weeks after initiation of treatment and 6 weeks after the initiation of treatment.

Study Arms (2)

Non-Depressed Controls

OTHER

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.

Device: NIRSIT

Depressed Patients

ACTIVE COMPARATOR

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.

Device: NIRSIT

Interventions

NIRSIT DEVICE

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

Depressed Patients; Non-Depressed Controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Subjects who cannot sign informed consent.

Sponsors & Collaborators

• University of California, San Francisco: lead
• OBELAB, Inc.: collaborator
• San Francisco Veterans Affairs Medical Center: collaborator

Study Sites (1)

San Francisco Veterans Affairs Medical Center

San Francisco, California, 94121, United States

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Arthur Wallace, MD, PhD

  San Francisco Veterans Affairs Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anusha Badathala, MBBS

CONTACT

4152214810; Anusha.Badathala@ncire.org

Arthur Wallace, MD, PhD

CONTACT

4152214810; art.wallace@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Repeated NIRS measure comparison of patients being treated for Major Depressive Disorder with control, non-depressed subjects.

Study Record Dates

• First Submitted: February 20, 2019
• First Posted: August 19, 2019
• Study Start: January 4, 2019
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)