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RecruitingMajor Depressive Disorder

Transcranial Near Infrared Radiation and Cerebral Blood Flow in Depression - R33

Eligible age

18–65 yrs

Accepts

All genders

Locations

2 states

Healthy volunteers

No

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About this study

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.

Sponsor: NYU Langone Health

You may qualify if…

  • Participants must be able to give written informed consent and follow study procedures
  • Participants must be 18-65 years of age
  • Participants must have major depressive disorder; all the following conditions need to be met to ensure presence of significant depression symptoms:
  • 1. Meeting diagnostic criteria for Major Depressive Disorder (MDD) in the past two weeks, at the DSM-5 Mini-International Neuropsychiatric Interview (MINI)
  • 2. Inventory for Depressive Symptomatology Clinician-rated (IDS-C) total score ≥23 at screening
  • 3. Depression symptoms are the primary target of treatment or treatment-seeking.
  • Women of child-bearing potential must agree to use adequate contraception
  • Participants taking medications or psychotherapy approved for the treatment of major depressive disorder will need to be stable for at least 8 weeks prior to screen.

You may not qualify if…

  • Unwilling or unable to comply with study requirements
  • Patients judged to be at serious and imminent suicidal (C-SSRS≥4) or homicide risk, or currently in crisis such that inpatient hospitalization or other crisis management should take priority.
  • History of any or psychotic or bipolar disorder
  • Met diagnostic criteria for an alcohol or substance use disorder, post-traumatic stress disorder, obsessive-compulsive disorder, anorexia nervosa, or bulimia nervosa within the preceding 6 months
  • History of dementia, traumatic brain injury (TBI), or neurological disorders affecting the brain, including any history of stroke or seizure disorders requiring treatment in the last 5 years
  • Cognitive impairment significant as determined by the Montreal Cognitive Assessment (MOCA) \<22 or MOCA-Blind \<19.
  • History of antisocial personality disorder, or any clinically significant personality trait that would, in the investigator's judgment, preclude safe study participation or impair ability to remain adherent with the treatment protocol
  • History of significant treatment non-adherence or situations where the subjects are unlikely to adhere to treatment, in the opinion of the investigator.

Where it's recruiting

New York

New York · Orangeburg

Source: ClinicalTrials.gov · NCT05573074 · last updated 2026-02-05

Transcranial Near Infrared Radiation and Cerebral Blood Flow in Depres · TrialPath