Transcranial Photobiomodulation for the Treatment of Pediatric Depression

NCT04579185 | Withdrawn

• 1 other identifier: 2020P002694
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

An open label trial to assess the safety and efficacy of transcranial photobiomodulation (tPBM) in improving symptoms of depression in youth.

Conditions

Depression

Keywords

light therapy; pediatric depression; depression; MDD

Outcome Measures

Primary Outcomes (1)

• Efficacy-Major Depressive Disorder (Clinical Global Impression - Major Depressive Disorder)

  To evaluate the efficacy of transcranial photobiomodulation in treatment of depression. The Clinical Global Impression Scale rates symptoms of depression from a scale of 1 (normal, not at all ill) to 7 (among the most extremely ill patients), with higher scores on this scale indicating a worse outcome.

  Baseline to Week 8

Secondary Outcomes (1)

• Safety (The Transcranial Photobiomodulation Self-Report Questionnaire)

  Baseline to Week 8

Study Arms (1)

Transcranial Photobiomodulation

EXPERIMENTAL

Transcranial Photobiomodulation--a noninvasive intervention in which near-infrared light (850 nanometer) is applied to forebrain.

Device: Transcranial Photobiomodulation

Interventions

Transcranial Photobiomodulation DEVICE

Transcranial Photobiomodulation--a noninvasive intervention in which near-infrared light (850 nanometer) is applied to forebrain.

Also known as: Niraxx G1 Headband

Transcranial Photobiomodulation

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male and female children aged 6- 17 years
• A CBCL T score of ≥ 60 on the Anxious/Depressed scale
• Current treatment with a psychotropic medication or psychological treatment will be allowed provided that no medication or psychological treatment changes occur during the study

You may not qualify if:

• Clinically unstable current psychiatric conditions judged to be a serious safety risk to self or others such as active suicidal ideation, psychosis or mania
• Subjects with an unstable medical condition that requires clinical attention
• The subject has a significant skin condition at the procedure sites (i.e., hemangioma, scleroderma, psoriasis, rash, open wound or tattoo).
• Inadequate command of the English language
• History of neurological injury or disease
• Impaired intellectual capacity (clinically determined)
• The subject has an implant of any kind in the head (e.g. stent, clipped aneurysm, embolised AVM, implantable shunt - Hakim valve).
• Any use of light-activated drugs (photodynamic therapy) within 14 days prior to study enrollment (in US: Visudine (verteporfin) - for age related macular degeneration; Aminolevulinic Acid- for actinic keratoses; Photofrin (porfimer sodium) - for esophageal cancer, non-small cell lung cancer; Levulan Kerastick (aminolevulinic acid HCl) - for actinic keratosis; 5-aminolevulinic acid (ALA)- for non-melanoma skin cancer
• Investigator and his/her immediate family, defined as the investigator's spouse, parent, child, grandparent, or grandchild

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Related Publications (10)

• Barrett B, Byford S, Knapp M. Evidence of cost-effective treatments for depression: a systematic review. J Affect Disord. 2005 Jan;84(1):1-13. doi: 10.1016/j.jad.2004.10.003.

  PMID: 15620380 BACKGROUND

• Cassano P, Petrie SR, Hamblin MR, Henderson TA, Iosifescu DV. Review of transcranial photobiomodulation for major depressive disorder: targeting brain metabolism, inflammation, oxidative stress, and neurogenesis. Neurophotonics. 2016 Jul;3(3):031404. doi: 10.1117/1.NPh.3.3.031404. Epub 2016 Mar 4.

  PMID: 26989758 BACKGROUND

• Eells JT, Henry MM, Summerfelt P, Wong-Riley MT, Buchmann EV, Kane M, Whelan NT, Whelan HT. Therapeutic photobiomodulation for methanol-induced retinal toxicity. Proc Natl Acad Sci U S A. 2003 Mar 18;100(6):3439-44. doi: 10.1073/pnas.0534746100. Epub 2003 Mar 7.

  PMID: 12626762 BACKGROUND

• Frye MA, Helleman G, McElroy SL, Altshuler LL, Black DO, Keck PE Jr, Nolen WA, Kupka R, Leverich GS, Grunze H, Mintz J, Post RM, Suppes T. Correlates of treatment-emergent mania associated with antidepressant treatment in bipolar depression. Am J Psychiatry. 2009 Feb;166(2):164-72. doi: 10.1176/appi.ajp.2008.08030322. Epub 2008 Nov 17.

  PMID: 19015231 BACKGROUND

• Leverich GS, Altshuler LL, Frye MA, Suppes T, McElroy SL, Keck PE Jr, Kupka RW, Denicoff KD, Nolen WA, Grunze H, Martinez MI, Post RM. Risk of switch in mood polarity to hypomania or mania in patients with bipolar depression during acute and continuation trials of venlafaxine, sertraline, and bupropion as adjuncts to mood stabilizers. Am J Psychiatry. 2006 Feb;163(2):232-9. doi: 10.1176/appi.ajp.163.2.232.

  PMID: 16449476 BACKGROUND

• Merikangas KR, He JP, Burstein M, Swanson SA, Avenevoli S, Cui L, Benjet C, Georgiades K, Swendsen J. Lifetime prevalence of mental disorders in U.S. adolescents: results from the National Comorbidity Survey Replication--Adolescent Supplement (NCS-A). J Am Acad Child Adolesc Psychiatry. 2010 Oct;49(10):980-9. doi: 10.1016/j.jaac.2010.05.017. Epub 2010 Jul 31.

  PMID: 20855043 BACKGROUND

• Mochizuki-Oda N, Kataoka Y, Cui Y, Yamada H, Heya M, Awazu K. Effects of near-infra-red laser irradiation on adenosine triphosphate and adenosine diphosphate contents of rat brain tissue. Neurosci Lett. 2002 May 3;323(3):207-10. doi: 10.1016/s0304-3940(02)00159-3.

  PMID: 11959421 BACKGROUND

• Schiffer F, Johnston AL, Ravichandran C, Polcari A, Teicher MH, Webb RH, Hamblin MR. Psychological benefits 2 and 4 weeks after a single treatment with near infrared light to the forehead: a pilot study of 10 patients with major depression and anxiety. Behav Brain Funct. 2009 Dec 8;5:46. doi: 10.1186/1744-9081-5-46.

  PMID: 19995444 BACKGROUND

• Uchida M, Fitzgerald M, Woodworth H, Carrellas N, Kelberman C, Biederman J. Subsyndromal Manifestations of Depression in Children Predict the Development of Major Depression. J Pediatr. 2018 Oct;201:252-258.e1. doi: 10.1016/j.jpeds.2018.05.049. Epub 2018 Jul 13.

  PMID: 30007773 BACKGROUND

• Zhang Q, Ma H, Nioka S, Chance B. Study of near infrared technology for intracranial hematoma detection. J Biomed Opt. 2000 Apr;5(2):206-13. doi: 10.1117/1.429988.

  PMID: 10938785 BACKGROUND

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Carrie Vaudreuil, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 1, 2020
• First Posted: October 8, 2020
• Study Start: November 1, 2020
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2023
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share