Recruiting
Near Infrared Spectroscopy (NIRS) for Assessment of Depression
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.
ClinicalTrials.gov IDNCT04061148
PhaseNA
Enrollment90
SponsorUniversity of California, San Francisco
Age18 Years and older
SexALL
Conditions studied
Major Depressive Disorder
About this study
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.
Interventions
- Device: NIRSIT — NIRSIT is a device that utilizes Near Infrared Spectroscopy to provide a non-invasive measurement of frontal lobe blood oxygenation over time.
Primary outcomes
- 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.)
Eligibility information
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 locations
- San Francisco Veterans Affairs Medical Center, San Francisco, California 94121 United States
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-11-01.