tPBM Group for Major Depressive Disorder (MDD)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Major Depressive Disorder (MDD)+2 More
Transcranial Photobiomodulator - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

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.

Eligible Conditions
  • Major Depressive Disorder (MDD)

Treatment Effectiveness

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: Baseline, Visit 18 (Week 10)

Week 8
Change in the Montgomery-Asberg Depression Rating Scale (MADRS) score
Week 10
Core-Binding Factor
Week 10
Percent change of cerebral blood flow (CBF) at endpoint in relation to treatment outcome

Trial Safety

Trial Design

2 Treatment Groups

Sham Group
1 of 2
tPBM Group
1 of 2

Active Control

Experimental Treatment

120 Total Participants · 2 Treatment Groups

Primary Treatment: tPBM Group · No Placebo Group · N/A

tPBM GroupExperimental Group · 2 Interventions: Transcranial Photobiomodulator, Sham · Intervention Types: Device, Device
Sham GroupActiveComparator Group · 2 Interventions: Transcranial Photobiomodulator, Sham · Intervention Types: Device, Device
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

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, visit 18 (week 10)

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,251 Previous Clinical Trials
743,658 Total Patients Enrolled
4 Trials studying Major Depressive Disorder (MDD)
341 Patients Enrolled for Major Depressive Disorder (MDD)
National Institutes of Health (NIH)NIH
2,418 Previous Clinical Trials
24,557,447 Total Patients Enrolled
11 Trials studying Major Depressive Disorder (MDD)
963 Patients Enrolled for Major Depressive Disorder (MDD)
Dan Iosifescu, MDPrincipal InvestigatorNYU Langone Health
5 Previous Clinical Trials
400 Total Patients Enrolled
3 Trials studying Major Depressive Disorder (MDD)
191 Patients Enrolled for Major Depressive Disorder (MDD)

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You must be able to give written informed consent and follow study procedures.
You are eligible if you are 18 years of age or older.
You have experienced at least two weeks of a major depressive episode
You have a primary diagnosis of depression.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 5th, 2021

Last Reviewed: November 15th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.