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Photobiomodulation
Transcranial Photobiomodulation for Depression (TRIADE-R33 Trial)
N/A
Recruiting
Led By Dan Iosifescu, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must be 18-65 years of age
Participants must be 18-65 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, visit 18 (week 10)
Awards & highlights
TRIADE-R33 Trial Summary
This trial studies if near-infrared light can help treat depression by changing blood flow in the brain. Near-infrared light is like regular light, but not visible to us.
Who is the study for?
Adults aged 18-65 with Major Depressive Disorder, stable on current medications or psychotherapy for at least 8 weeks, and not in immediate crisis. They must score ≥23 on the IDS-C for depression severity and be able to consent to study procedures. Excludes those with certain psychiatric disorders, substance abuse issues, significant medical conditions, or using specific depression treatments.Check my eligibility
What is being tested?
The trial is testing if near infrared energy applied to the forehead can alter brain blood flow in depressed individuals. Participants will either receive the actual Transcranial Photobiomodulator treatment or a sham (placebo) procedure to compare effects.See study design
What are the potential side effects?
Potential side effects are not specified but may include discomfort at the application site or unforeseen reactions due to light sensitivity. The treatment is non-invasive so risks are expected to be minimal compared to drug therapies.
TRIADE-R33 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 65 years old.
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I am between 18 and 65 years old.
Select...
I am between 18 and 65 years old.
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I have been diagnosed with major depressive disorder with significant symptoms.
TRIADE-R33 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, visit 18 (week 10)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, visit 18 (week 10)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Core-Binding Factor
Secondary outcome measures
Change in the Montgomery-Asberg Depression Rating Scale (MADRS) score
Percent change of cerebral blood flow (CBF) at endpoint in relation to treatment outcome
TRIADE-R33 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: tPBM GroupExperimental Treatment2 Interventions
Visit 1: t-PBM at irradiance dose of 291.7 mW/cm2 (333s) Visit 2 - 18: randomized to receive active t-PBM of 291.7 mW/cm2 (333s) Visit 19: t-PBM at irradiance dose of 291.7 mW/cm2 (333s)
Group II: Sham GroupActive Control2 Interventions
Visit 1: t-PBM at irradiance does of 291.7 mW/cm2 (333s) Visit 2 - 18: randomized to receive Sham of 0 mW/cm2 (333s) Visit 19: t-PBM at irradiance dose of 291.7 mW/cm2 (333s)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transcranial Photobiomodulator
2020
N/A
~60
Sham
2013
Completed Phase 3
~2060
Find a Location
Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,368 Previous Clinical Trials
839,619 Total Patients Enrolled
22 Trials studying Depression
1,502 Patients Enrolled for Depression
National Institutes of Health (NIH)NIH
2,696 Previous Clinical Trials
6,952,460 Total Patients Enrolled
54 Trials studying Depression
47,028 Patients Enrolled for Depression
Dan Iosifescu, MDPrincipal InvestigatorNYU Langone Health
5 Previous Clinical Trials
399 Total Patients Enrolled
3 Trials studying Depression
219 Patients Enrolled for Depression
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 65 years old.I haven't had ECT in the past year, VNS ever, or been resistant to device-based depression treatments.My thyroid condition is stable, and I've been on medication for at least a month.I have been on a stable treatment for depression for at least 8 weeks.I am using a device or taking non-SSRI/SNRI/Wellbutrin medication for depression.I am seeking treatment mainly for my depression symptoms.I have depression and haven't improved after trying two different antidepressants.My health is stable and I don't have uncontrolled serious illnesses.I have skin conditions like rashes or wounds on my scalp where the procedure will be.I have not had dementia, significant brain injuries, strokes, or seizures needing treatment in the last 5 years.I am between 18 and 65 years old.My depression treatment has been stable for at least 8 weeks.You must be able to give written informed consent and follow study procedures.I am between 18 and 65 years old.You have experienced at least two weeks of a major depressive episodeI am not at immediate risk of harming myself or others.I have not used any light-activated drugs in the last 14 days.I cannot have an MRI due to safety concerns like claustrophobia or metal in my body.I have been diagnosed with major depressive disorder with significant symptoms.
Research Study Groups:
This trial has the following groups:- Group 1: Sham Group
- Group 2: tPBM Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Depression Patient Testimony for trial: Trial Name: NCT05573074 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this testing protocol open to individuals of advanced age?
"This trial is accepting applicants who have reached the age of consent but are under 65 years old."
Answered by AI
Do I qualify to participate in this medical research?
"The requirements for enrollment in this medical experiment are a diagnosis of major depressive disorder (MDD) and an age between 18 to 65. Roughly 120 volunteers are needed for the trial."
Answered by AI
Is recruitment for this medical experiment currently available?
"As per clinicaltrials.gov, the recruitment phase of this medical trial has been concluded as it was most recently updated on October 6th 2022. Nonetheless, 826 other studies are still recruiting patients at present."
Answered by AI
Who else is applying?
What state do they live in?
Pennsylvania
New Jersey
New York
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
Other
Nathan Kline Institute for Psychiatric Research
Harvard Medical School
NYU Langone Health
How many prior treatments have patients received?
1
2
0
3+
What questions have other patients asked about this trial?
How long do screening visits take? How often are the screening visits? how far are you from Penn station New York?
PatientReceived 1 prior treatment
Are there any studies for depression in Michigan? Ann Arbor? Detroit areas?
PatientReceived 1 prior treatment
Why did patients apply to this trial?
Tried several meds. Want to get better. interested in finding help. I tried a lot of different things.
PatientReceived 1 prior treatment
I've tried 5 or more drugs and tms.
PatientReceived 1 prior treatment
How responsive is this trial?
Typically responds via
Email
Phone Call
Average response time
- < 2 Days
Most responsive sites:
- Nathan Kline Institute for Psychiatric Research: < 48 hours
- Harvard Medical School: < 48 hours
- NYU Langone Health: < 48 hours
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