BridgeMD
New treatment option for Major Depressive Disorder
Official title Transcranial Near Infrared Radiation and Cerebral Blood Flow in Depression - R33
ClinicalTrials.gov ID: NCT05573074
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join 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:
- Meeting diagnostic criteria for Major Depressive Disorder (MDD) in the past two weeks, at the DSM-5 Mini-International Neuropsychiatric Interview...
- Inventory for Depressive Symptomatology Clinician-rated (IDS-C) total score ≥23 at screening
You likely can't join 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...
- 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...
- History of dementia, traumatic brain injury (TBI), or neurological disorders affecting the brain, including any history of stroke or seizure...
- Cognitive impairment significant as determined by the Montreal Cognitive Assessment (MOCA) \<22 or MOCA-Blind \<19.
See the full eligibility criteria
- 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:
- Meeting diagnostic criteria for Major Depressive Disorder (MDD) in the past two weeks, at the DSM-5 Mini-International Neuropsychiatric Interview (MINI)
- Inventory for Depressive Symptomatology Clinician-rated (IDS-C) total score ≥23 at screening
- 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.
- 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...
- History of significant treatment non-adherence or situations where the people are unlikely to adhere to treatment, in the opinion of the investigator.
- Pregnant (as confirmed by pregnancy test at screen) or nursing
- Currently undergoing device-based treatment for depression or taking medications for depression other than SSRIs, SNRIs, or Wellbutrin (bupropion).
- Treatment resistance with failure to respond to more than two adequate treatments with FDA-approved antidepressant medications during current episode of major depressive disorder.
- History of ECT in the last 12 months; lifetime history of VNS; lifetime treatment resistance to any FDA-approved device-based treatment for major depressive disorder (such as ECT, TMS, VNS); device-based interventions...
- Serious, unstable medical illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, hematologic disease; defined as any medical illness which is not...
- Clinical or laboratory evidence of uncontrolled hypothyroidism; if maintained on thyroid medication must be euthyroid for at least 1 month before screening.
- Past intolerance or hypersensitivity to tPBM.
- Significant skin conditions (i.e., hemangioma, scleroderma, psoriasis, rash, open wound or tattoo) on the subject's scalp that are found in the area of the procedure sites.
- Any use of light-activated drugs (photodynamic therapy) within 14 days prior to study enrollment.
- Any type of implants in the head, whose functioning might be affected by tPBM (e.g., stent, clipped aneurysm, embolized AVM, implantable shunt - Hakim valve).
- Failure to meet standard MRI safety requirements (e.g., claustrophobia, non-removable piercings, implanted medical devices, other non-removable metals) as determined by the MRI Safety Checklist.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
- New York, New York, United States
- Orangeburg, New York, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States; New York, New York, United States; Orangeburg, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.