Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Near Infrared Spectroscopy (NIRS) for Assessment of Depression (NIRSIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04061148
Recruitment Status : Recruiting
First Posted : August 19, 2019
Last Update Posted : September 12, 2019
Sponsor:
Collaborators:
Obelab Inc.
San Francisco Veterans Affairs Medical Center
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Device: NIRSIT Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Repeated NIRS measure comparison of patients being treated for Major Depressive Disorder with control, non-depressed subjects.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Clinical Testing of Near Infrared Spectroscopy (NIRS) for Quantitative Assessment of Depression
Actual Study Start Date : January 4, 2019
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

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

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.
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 :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.


Secondary Outcome Measures :
  1. Hamilton Depression Rating Scale (HAM-D) Score [ 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. ]
    Changes in HAM-D Scores before, during and after treatment of MDD. The score range is 0-50, with 50 indicating most severe depression.

  2. Beck's Depression Inventory - II (BDI-II) Scores [ 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. ]
    Changes in BDI-II Scores before, during and after treatment of MDD. The score range is 0-63, with 63 indicating most severe depression.

  3. Patient Health Questionnaire-9 (PHQ-9) Scores [ 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. ]
    Changes in PHQ-9 Scores before, during and after treatment of MDD. The score range is 0-27, with 27 indicating most severe depression.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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'

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04061148


Contacts
Layout table for location contacts
Contact: Anusha Badathala, MBBS 4152214810 ext 22798 Anusha.Badathala@ncire.org
Contact: Arthur Wallace, MD, PhD 4152214810 ext 23732 art.wallace@va.gov

Locations
Layout table for location information
United States, California
San Francisco Veterans Affairs Medical Center Recruiting
San Francisco, California, United States, 94121
Contact: Arthur Wallace, MD, PhD         
Sponsors and Collaborators
University of California, San Francisco
Obelab Inc.
San Francisco Veterans Affairs Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Arthur Wallace, MD, PhD San Francisco Veterans Affairs Medical Center
  Study Documents (Full-Text)

Documents provided by University of California, San Francisco:
Study Protocol  [PDF] October 31, 2018


Layout table for additonal information
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04061148    
Other Study ID Numbers: 17-22188
First Posted: August 19, 2019    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: September 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of California, San Francisco:
Near Infrared Spectroscopy
Depression
NIRS
Major Depressive Disorder
Additional relevant MeSH terms:
Layout table for MeSH terms
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders