Clinical Research Studies

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

• Conditions:
  Major Depressive Disorder
• Age: Between 18 years - 65 years
• Gender: Male or Female

• Other Inclusion Criteria:
  

  1. Participants must be able to give written informed consent and follow study procedures
  2. Participants must have major depressive disorder
  3. Women of child-bearing potential must agree to use adequate contraception
  4. 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
  5. Participants must be able to fit comfortably in the study scanner while wearing the study device and tolerate a single dose of high-irradiance tPBM.

  
  

You may not be eligible for this study if the following are true:

• 1. Unwilling or unable to comply with study requirements
  2. Participants 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.
  3. Has history of any or psychotic or bipolar disorder
  4. Participants with diagnostic criteria for an alcohol or substance use disorder, post-traumatic stress disorder, obsessive-compulsive disorder, anorexia nervosa, or bulimia nervosa
  5. History of dementia, traumatic brain injury (TBI), or neurological disorders affecting the brain, including any history of stroke.
  6. Participants with cognitive impairment significant as determined by the Montreal Cognitive Assessment (MOCA) <22 or MOCA-Blind <19.
  7. Has history of antisocial personality disorder, or any clinically significant personality trait
  8. History of significant treatment non-adherence or situations.
  9. Participants who are pregnant or nursing.
  10. Currently undergoing device-based treatment for depression or taking medications for depression other than SSRIs or SNRIs.
  11. Treatment resistance with failure to respond to more than two adequate treatments with FDA-approved antidepressant medications during current episode of major depressive disorder
  12. Participants who have history of electroconvulsive therapy (ECT) in the last 12 months; lifetime history of Vagus nerve stimulation (VNS); lifetime treatment resistance to any FDA-approved device-based treatment for major depressive disorder
  13. Participants with serious, unstable medical illnesses
  14. Clinically significant abnormal findings of laboratory parameters
  15. Clinical or laboratory evidence of uncontrolled hypothyroidism
  16. Past intolerance or hypersensivity to t-PBM.