NCT04061148 · University of California, San Francisco
Near Infrared Spectroscopy (NIRS) for Assessment of Depression
(NIRSIT)
What this study is about
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.
View original scientific description
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 outcome measures
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 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.
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 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.
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 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.
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 Deoxyhemoglobin concentration in frontal blood from the baseline during the performance of Verbal Fluency Task and Cartoon humor reaction task by the subject.
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 Deoxyhemoglobin concentration in frontal blood from the baseline during the performance of Verbal Fluency Task and Cartoon humor reaction task by the subject.
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.
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- San Francisco, California
Collaborators
OBELAB, Inc., San Francisco Veterans Affairs Medical Center
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 20, 2025 · Source of record for eligibility and locations