Near Infrared Spectroscopy (NIRS) for Assessment of Depression
ConditionMajor Depressive Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, San Francisco
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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'
Trial design
Design model
Parallel
Treatments tested in this trial
NIRSIT
DeviceNIRSIT is a device that utilizes Near Infrared Spectroscopy to provide a non-invasive measurement of frontal lobe blood oxygenation over time.
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: Non-Depressed ControlsOther 1 intervention
Group B: Depressed PatientsActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
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.2
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.
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.3
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.
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.4
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.
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.Secondary outcomes
1
Hamilton Depression Rating Scale (HAM-D) Score
Changes in HAM-D Scores before, during and after treatment of MDD. The score range is 0-50, with 50 indicating most severe depression.
Time frame
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.2
Beck's Depression Inventory - II (BDI-II) Scores
Changes in BDI-II Scores before, during and after treatment of MDD. The score range is 0-63, with 63 indicating most severe depression.
Time frame
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.3
Patient Health Questionnaire-9 (PHQ-9) Scores
Changes in PHQ-9 Scores before, during and after treatment of MDD. The score range is 0-27, with 27 indicating most severe depression.
Time frame
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, San Francisco
Lead sponsor
OBELAB, Inc.
Collaborator
San Francisco Veterans Affairs Medical Center
Collaborator
Source ClinicalTrials.gov