DepressionNCT04579185
Transcranial Photobiomodulation for the Treatment of Pediatric Depression
A study testing Transcranial Photobiomodulation in people with Depression, run by Massachusetts General Hospital.
Trial summary
An open label trial to assess the safety and efficacy of transcranial photobiomodulation (tPBM) in improving symptoms of depression in youth. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Depression
- What is being tested?
- Transcranial Photobiomodulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2020to Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- 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
About this study
Official title: Detailed Protocol: Evaluation of Transcranial Photobiomodulation for the Treatment of Pediatric Depression: An Open-Label Pilot Study
An open label trial to assess the safety and efficacy of transcranial photobiomodulation (tPBM) in improving symptoms of depression in youth.
Read the detailed description
Pediatric depression is a prevalent and morbid disorder estimated to affect up to 12% of youth in the United States by the time they reach adolescence. Recent research has documented that even minor symptoms of depression as captured through the Child Behavior Checklist (CBCL) Anxiety/Depression scale are strongly associated with the subsequent development of major depression. While treatments with antidepressants and psychotherapy are available, antidepressants can be associated with adverse effects including manic activation and psychosocial interventions are costly and not wide available. This state of affairs supports the search for safe and effective alternative treatments.
One such opportunity is transcranial LED therapy, also known as transcranial photobiomodulation (tPBM). The treatment consists of exposing the frontal brain to the tPBM bilaterally, which is hypothesized to enhance adenosine triphosphate (ATP) production in depressed subjects. tPBM is a non-ionizing electromagnetic wave. It is invisible, penetrates the skin and skull into brain tissue, is non-invasive, is minimally dissipated as thermal energy, and is mainly absorbed by specific chromophores. The benefits of tPBM are wavelength specific. A mitochondrial enzyme, the cytochrome c oxidase, is the primary chromophore for the tPBM, with a wavelength around 830 nm. The energy absorbed by the cytochrome c oxidase leads to increased ATP production through the respiratory chain. Ultimately, the increased ATP is thought to lead to increased energy metabolism for the cell, and it is hypothesized that a signaling cascade is activated promoting cellular plasticity and cytoprotection. These properties of the tPBM have led to novel therapeutic applications in psychiatry. A preliminary open label study in 10 depressed subjects has shown that the tPBM was safe, effective and well tolerated in depressed adults. Further research confirmed these findings and shown tPBM therapy to be a promising intervention for adults with MDD. However, whether this non-invasive intervention may be safe and effective in pediatric depression remains unknown.
To this end the investigators propose a pilot study is to evaluate whether tPBM is safe and effective in the treatment of pediatric depression. This study will enroll 30 youth of both sexes 6-17 years with active symptoms of depression as assessed through elevated scores on the CBCL Anxiety/depression scale. Based on the adult literature, investigators hypothesize that it will be safe and effective in this population.
- Conditions
- Depression
- Being tested
- Transcranial Photobiomodulation
- Keywords
- light therapy, pediatric depression, depression, MDD
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial PhotobiomodulationDevice
Also called Niraxx G1 Headband
Transcranial Photobiomodulation--a noninvasive intervention in which near-infrared light (850 nanometer) is applied to forebrain.
| Study group | Role | What they receive |
|---|---|---|
| Transcranial Photobiomodulation | Experimental | Transcranial Photobiomodulation--a noninvasive intervention in which near-infrared light (850 nanometer) is applied to forebrain. Receives: Device: Transcranial Photobiomodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Week 8
Secondary outcomes (1)
Safety (The Transcranial Photobiomodulation Self-Report Questionnaire)
To assess the safety of transcranial photobiomodulation for treatment of depression. The Transcranial Photobiomodulation (tPBM) Self-Report Questionnaire rates the patient's comfort/discomfort with the tPBM on a scale of 0 (not discomfort) to 5 (extreme discomfort), with higher scores on this scale indicating a worse outcome.
Measured: Baseline to Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study startNov 2020 (estimated)
- Primary completionNov 2022 (estimated)
- Study completionNov 2023 (estimated)
Why it stopped: Due to COVID, this study was not initiated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carrie Vaudreuil, Massachusetts General Hospital
- Investigators
- Carrie Vaudreuil, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04579185
- Sponsor's protocol ID
- 2020P002694
- Status last verified
- Mar 2024
- First submitted
- 1 Oct 2020
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 15620380Cassano 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.
PubMed 26989758Eells 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.
PubMed 12626762Frye 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.
PubMed 19015231Leverich 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.
PubMed 16449476Merikangas 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.
PubMed 20855043Mochizuki-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.
PubMed 11959421Schiffer 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.
PubMed 19995444Uchida 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.
PubMed 30007773Zhang 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.
PubMed 10938785
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detailed Protocol: Evaluation of Transcranial Photobiomodulation for the Treatment of Pediatric Depression: An Open-Label Pilot Study
- ClinicalTrials.gov ID
- NCT04579185
- Acronym / sponsor ID
- 2020P002694
- Conditions
- Depression
- Keywords
- light therapy, pediatric depression, depression, MDD
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to COVID, this study was not initiated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Nov 2020 (estimated)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 8 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An open label trial to assess the safety and efficacy of transcranial photobiomodulation (tPBM) in improving symptoms of depression in youth.
Detailed description
Pediatric depression is a prevalent and morbid disorder estimated to affect up to 12% of youth in the United States by the time they reach adolescence. Recent research has documented that even minor symptoms of depression as captured through the Child Behavior Checklist (CBCL) Anxiety/Depression scale are strongly associated with the subsequent development of major depression. While treatments with antidepressants and psychotherapy are available, antidepressants can be associated with adverse effects including manic activation and psychosocial interventions are costly and not wide available. This state of affairs supports the search for safe and effective alternative treatments.
One such opportunity is transcranial LED therapy, also known as transcranial photobiomodulation (tPBM). The treatment consists of exposing the frontal brain to the tPBM bilaterally, which is hypothesized to enhance adenosine triphosphate (ATP) production in depressed subjects. tPBM is a non-ionizing electromagnetic wave. It is invisible, penetrates the skin and skull into brain tissue, is non-invasive, is minimally dissipated as thermal energy, and is mainly absorbed by specific chromophores. The benefits of tPBM are wavelength specific. A mitochondrial enzyme, the cytochrome c oxidase, is the primary chromophore for the tPBM, with a wavelength around 830 nm. The energy absorbed by the cytochrome c oxidase leads to increased ATP production through the respiratory chain. Ultimately, the increased ATP is thought to lead to increased energy metabolism for the cell, and it is hypothesized that a signaling cascade is activated promoting cellular plasticity and cytoprotection. These properties of the tPBM have led to novel therapeutic applications in psychiatry. A preliminary open label study in 10 depressed subjects has shown that the tPBM was safe, effective and well tolerated in depressed adults. Further research confirmed these findings and shown tPBM therapy to be a promising intervention for adults with MDD. However, whether this non-invasive intervention may be safe and effective in pediatric depression remains unknown.
To this end the investigators propose a pilot study is to evaluate whether tPBM is safe and effective in the treatment of pediatric depression. This study will enroll 30 youth of both sexes 6-17 years with active symptoms of depression as assessed through elevated scores on the CBCL Anxiety/depression scale. Based on the adult literature, investigators hypothesize that it will be safe and effective in this population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transcranial Photobiomodulation | Experimental | Device: Transcranial PhotobiomodulationTranscranial Photobiomodulation--a noninvasive intervention in which near-infrared light (850 nanometer) is applied to forebrain. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial PhotobiomodulationAlso: Niraxx G1 HeadbandTranscranial Photobiomodulation--a noninvasive intervention in which near-infrared light (850 nanometer) is applied to forebrain. | Device | Transcranial Photobiomodulation |
Primary outcome
Efficacy-Major Depressive Disorder (Clinical Global Impression - Major Depressive Disorder)
Time frame: Baseline to Week 8
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.
1 secondary outcome
Safety (The Transcranial Photobiomodulation Self-Report Questionnaire)
Time frame: Baseline to Week 8
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Background: PubMed 15620380Barrett 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.
- Background: PubMed 26989758Cassano 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.
- Background: PubMed 12626762Eells 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.
- Background: PubMed 19015231Frye 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.
- Background: PubMed 16449476Leverich 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.
- Background: PubMed 20855043Merikangas 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.
- Background: PubMed 11959421Mochizuki-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.
- Background: PubMed 19995444Schiffer 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.
- Background: PubMed 30007773Uchida 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.
- Background: PubMed 10938785Zhang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carrie Vaudreuil, MD principal investigator
Massachusetts General Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Photobiomodulation in people with Depression, run by Massachusetts General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy-Major Depressive Disorder (Clinical Global Impression - Major Depressive Disorder) (time frame: Baseline to Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04579185, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.