Actively Recruiting
Transcranial Near Infrared Radiation and Cerebral Blood Flow in Depression - R33
Led by NYU Langone Health · Updated on 2026-02-05
120
Participants Needed
3
Research Sites
169 weeks
Total Duration
On this page
Sponsors
N
NYU Langone Health
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this research study is to determine if application of near infrared energy to the forehead can change blood flow in the brains of people with depression. Near infrared energy is like light but is not visible to the human eye.
CONDITIONS
Official Title
Transcranial Near Infrared Radiation and Cerebral Blood Flow in Depression - R33
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to give written informed consent and follow study procedures
- Age between 18 and 65 years
- Diagnosed with Major Depressive Disorder within the past two weeks according to DSM-5 MINI
- Inventory for Depressive Symptomatology Clinician-rated (IDS-C) score of 23 or higher at screening
- Depression symptoms are the primary reason for treatment or seeking treatment
- Women of child-bearing potential agree to use adequate contraception
- Stable on medications or psychotherapy for depression for at least 8 weeks before screening
You will not qualify if you...
- Unwilling or unable to comply with study requirements
- At serious or imminent risk of suicide or homicide, or currently in crisis requiring hospitalization
- History of psychotic or bipolar disorder
- Diagnosed with alcohol or substance use disorder, PTSD, OCD, anorexia nervosa, or bulimia nervosa within the last 6 months
- History of dementia, traumatic brain injury, stroke, seizure disorders requiring treatment in the last 5 years, or other neurological disorders affecting the brain
- Significant cognitive impairment (MOCA score below 22 or MOCA-Blind below 19)
- History of antisocial personality disorder or other personality traits that impair safe participation or adherence
- Significant prior treatment non-adherence or unlikely to adhere to treatment
- Pregnant or nursing
- Currently receiving device-based treatments for depression or taking antidepressants other than SSRIs, SNRIs, or Wellbutrin
- Treatment resistance defined as failure to respond to more than two adequate antidepressant treatments during current episode
- History of ECT in the last 12 months, lifetime VNS, or lifetime resistance to FDA-approved device treatments for depression; device treatments must be stopped at least 8 weeks before screening
- Serious unstable medical illnesses including hepatic, renal, gastrointestinal, respiratory, cardiovascular, endocrine, neurological, immunologic, or hematologic diseases
- Clinically significant abnormal lab findings including positive drug screen
- Uncontrolled hypothyroidism or not euthyroid for at least 1 month if on thyroid medication
- Past intolerance or hypersensitivity to tPBM
- Significant scalp skin conditions in the treatment area
- Use of light-activated drugs within 14 days before enrollment
- Head implants that might be affected by tPBM
- Failure to meet MRI safety requirements such as claustrophobia or incompatible implants or metals
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Harvard Medical School
Boston, Massachusetts, United States, 02114
Actively Recruiting
2
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
3
Nathan Kline Institute for Psychiatric Research
Orangeburg, New York, United States, 10962
Actively Recruiting
Research Team
D
Dan Iosifescu, MD
CONTACT
A
Anna Peterson
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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