RECRUITING

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

Conditions

Major Depressive Disorder MDD, transcranial Photobiomodulation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-04-01

Study Completion:2026-01-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05573074

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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: 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.	* 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. * 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 for depression will need to be discontinued at least 8 weeks prior to screen. * Serious, unstable medical illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, hematologic disease; defined as any medical illness which is not well-controlled with standard-of-care v Clinically significant abnormal findings of laboratory parameters including urine toxicology screen for drugs of abuse or at physical examination. * 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.

Inclusion Criteria

Exclusion 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:
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.

* 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.
* 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 for depression will need to be discontinued at least 8 weeks prior to screen.
* Serious, unstable medical illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, hematologic disease; defined as any medical illness which is not well-controlled with standard-of-care v Clinically significant abnormal findings of laboratory parameters including urine toxicology screen for drugs of abuse or at physical examination.
* 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.

Contacts and Locations

Study Contact

Dan Iosifescu, MD

CONTACT

646-754-5156

Dan.Iosifescu@nyulangone.org

Anna Peterson

CONTACT

646-754-2260

Anna.Peterson@nyulangone.org

Principal Investigator

Dan Iosifescu, MD

PRINCIPAL_INVESTIGATOR

NYU Langone Health

Study Locations (Sites)

Harvard Medical School

Boston, Massachusetts, 02114

United States

NYU Langone Health

New York, New York, 10016

United States

Nathan Kline Institute for Psychiatric Research

Orangeburg, New York, 10962

United States

Collaborators and Investigators

Sponsor: NYU Langone Health

Dan Iosifescu, MD, PRINCIPAL_INVESTIGATOR, NYU Langone Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-01

Study Completion Date2026-01-31

Study Record Updates

Study Start Date2023-04-01

Study Completion Date2026-01-31

Terms related to this study

Keywords Provided by Researchers

MDD, transcranial Photobiomodulation

Additional Relevant MeSH Terms

Major Depressive Disorder