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NIRS for Depression (NIRSIT Trial)
N/A
Recruiting
Led By Arthur Wallace, MD, PhD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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.
Awards & highlights
NIRSIT Trial Summary
This trial will test a new protocol using Near Infrared Spectroscopy to diagnose and measure the severity of Major Depressive Disorder.
Who is the study for?
This trial is for adults over 18 who are either not depressed (controls) or diagnosed with Major Depressive Disorder and currently receiving treatment at SFVAMC. Participants must be able to give informed consent. Those with anxiety, psychotic disorders, substance abuse issues, major neurocognitive disorders like Alzheimer's, or neurological conditions with lesions are excluded.Check my eligibility
What is being tested?
The trial is testing a new diagnostic protocol using NIRSIT technology to distinguish symptoms and severity of depression in patients compared to non-depressed individuals through up to five visits per subject.See study design
What are the potential side effects?
Since this study involves a non-invasive imaging technique (NIRSIT), there may be minimal side effects related directly to the procedure itself; however, specific side effects are not detailed in the provided information.
NIRSIT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am over 18 and do not have depression.
Select...
I am over 18 and diagnosed with Major Depressive Disorder, receiving treatment at SFVAMC.
NIRSIT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 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.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Frontal Deoxyhemoglobin concentration 3 weeks after initiation of treatment for MDD
Change in Frontal Deoxyhemoglobin concentration 6 weeks after initiation of treatment for MDD
Change in Frontal Deoxyhemoglobin concentration before initiation of treatment for MDD
+3 moreSecondary outcome measures
Beck's Depression Inventory - II (BDI-II) Scores
Hamilton Depression Rating Scale (HAM-D) Score
Patient Health Questionnaire-9 (PHQ-9) Scores
NIRSIT Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Non-Depressed ControlsExperimental Treatment1 Intervention
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.
Group II: Depressed PatientsActive Control1 Intervention
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.
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Who is running the clinical trial?
OBELAB, Inc.Industry Sponsor
1 Previous Clinical Trials
35 Total Patients Enrolled
Obelab Inc.UNKNOWN
University of California, San FranciscoLead Sponsor
2,496 Previous Clinical Trials
11,934,599 Total Patients Enrolled
71 Trials studying Depression
28,738 Patients Enrolled for Depression
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have depression, anxiety, major neurocognitive disorders like Alzheimer's, or neurologic disorders with brain lesions.I am over 18 and do not have depression.I am over 18 and diagnosed with Major Depressive Disorder, receiving treatment at SFVAMC.I do not have schizophrenia, Alzheimer's, brain injuries, or untreated depression.I am unable to sign the informed consent form.
Research Study Groups:
This trial has the following groups:- Group 1: Depressed Patients
- Group 2: Non-Depressed Controls
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still vacancies available for participants in this research project?
"According to the data posted on clinicaltrials.gov, this medical study is not actively looking for participants at present. The trial was initially launched on April 1st 2019 and has been edited as recently as August 10th 2020. Though no longer recruiting patients, 1317 other trials are currently in need of volunteers."
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