Near-infrared Transcranial Laser Therapy in Subjects With Major Depressive Disorder: A Study of Dosing With Laser

NCT05435820 | Unknown FDA Device

• 1 other identifier: NITLT01
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

The Near-infrared transcranial laser therapy (NIR-TLT) is a non-ionizing electromagnetic wave. The NIR-TLT is invisible, penetrates the skin and skull into brain tissue and is non-invasive. The benefits of NIR-TLT are wavelength specific. A mitochondrial enzyme, the Cytochrome c oxidase, is the primary chromophore for the NIR-TLT with a wavelength of around 830 nm. When this enzyme is activated, it leads to increased adenosine triphosphate (ATP) production and this event is related to the promotion of cellular plasticity and cytoprotection. These are critical cellular processes for recovery of the depressive patients. Therefore, this study will contribute to answer the question of whether NIR-TLT has an antidepressant effect and whether it is acceptable in minority population.

Conditions

Major Depressive Disorder

Keywords

Near-infrared transcranial laser therapy; Hamilton Depression rating scale; Major depressive Disorder; Clinical trial

Outcome Measures

Primary Outcomes (1)

• Changes in the scores of the Hamilton Depression Rating Scale (HAMD-17) from baseline to week 3 and week 6.

  The antidepressant effects of NIR-TLT doses will be measured using the Hamilton Depression rating scale (HAM-D 17). The HAM-D 17 is a 17-item clinician rated instrument developed to quantify the severity of depression in subjects already diagnosed with this disorder. The rating of this tool will be determined in an interview with the psychiatrist, yielding a maximum score of 52. Higher scores represent greater severity of depression.

  From baseline to week 3 and week 6.

Secondary Outcomes (5)

• Changes in the scores of the Quick Inventory of Depressive Symptomatology-Clinician Rated Scale (QIDS-CR) from baseline to week 3 and week 6.

  From baseline to week 3 and week 6.

• Changes in the scores of the Clinical Global Impressions - Severity (CGI-S) from baseline to week 3 and week 6.

  From baseline to week 3 and week 6.

• Changes of electroencephalogram (EEG) espectral power from baseline to week 3 and week 6.

  From baseline to week 3 and week 6.

• Changes in the scores of the Systemic Assessment for Treatment Emergent Events (SAFTEE-SI) from baseline to week 3 and week 6.

  From baseline to week 3 and week 6.

• Brain metabolism effect of NIR-TLT dose (exploratory assessment) from baseline to week 6.

  From baseline to week 6.

Study Arms (4)

BCW group

EXPERIMENTAL

NIR-TLT dose: i. Treatment site(s): EEG F3 and F4 ii. Temporal format: continuous wave iii. Average radiance: 350 mW / cm2 iv. Exposure time: 429 sec. v. Total fluence delivered: 3.6 kJ (1.8 kJ per treatment location)

Device: Near-infrared Transcranial Laser Therapy

BPW-1 group

EXPERIMENTAL

NIR-TLT dose: i. Treatment site(s): EEG F3 and F4 ii. Temporal format: pulsed wave, 10 Hz; 50% duty cycle iii. Average radiance: 350 mW / cm2 iv. Exposure time: 429 sec. v. Total fluence delivered: 3.6 kJ (1.8 kJ per treatment location)

Device: Near-infrared Transcranial Laser Therapy

BPW-2 group

EXPERIMENTAL

NIR-TLT dose: i. Treatment site(s): EEG F3 and F4 ii. Temporal format: pulsed wave, 40-50 Hz; 50% duty cycle iii. Average radiance: 350 mW / cm2 iv. Exposure time: 429 sec. v. Total fluence delivered: 3.6 kJ (1.8 kJ per treatment location)

Device: Near-infrared Transcranial Laser Therapy

SHAM group

SHAM COMPARATOR

NIR-TLT dose: i. Treatment site(s): none ii. Temporal format: none iii. Average radiance: 0 mW / cm2 iv. Exposure time: 429 sec. v. Total fluence delivered: 0 kJ

Device: Near-infrared Transcranial Laser Therapy

Interventions

Near-infrared Transcranial Laser Therapy DEVICE

The treatment consists in exposing bilaterally the frontal brain to Transcranial Laser Therapy, which may enhance ATP production in depressed subjects.

BCW group; BPW-1 group; BPW-2 group; SHAM group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects age at screening will be between 18 and 75 years old (inclusive).
• Diagnosis of major depressive disorder (Mini International Neuropsychiatric Interview, MINI)
• QIDS-CR≥12 at screening
• CGI-S ≥4 or higher, i.e., "moderately depressed"
• Women of child-bearing potential must use a double-barrier method for birth control (e.g. condoms plus spermicide) if sexually active.
• Subject Informed Consent obtained in writing in compliance with local regulations prior to enrollment into this study.
• The subject is willing to participate in this study for at least 12 weeks.
• Subjects will need to be on stable dose(s) of antidepressants (if taking any) for at least six weeks prior to enrollment.

You may not qualify if:

• Decrease in Symptoms of Depression Questionnaire (SDQ) self-report from screening to baseline \>=30%, calculated as \[(SDQ screening-88) - (SDQ initial-88) / (SDQ screening-88)\] \>=30/100. A score of 88 is "normal" in SDQ.
• The subject is pregnant or lactating.
• The subject failed more than 2 adequate treatments with FDA approved antidepressants during current episode per Antidepressant Treatment Response Questionnaire (ATRQ) criteria (less than 50% decrease in depressive symptomatology).
• Structured psychotherapy focused on treating the subject's depression is permitted if started at least 8 weeks prior to the screening visit.
• Substance dependence or abuse in the past 3 months.
• History of a psychotic disorder or psychotic episode (current psychotic episode per MINI assessment).
• Bipolar affective disorder (per MINI assessment).
• Unstable medical illness, defined as any medical illness which is not well-controlled with standard-of-care medications (e.g., insulin for diabetes mellitus).
• Active suicidal or homicidal ideation (both intention and plan are present), as determined by Columbia-Suicide Severity Rating Scale (C-SSRS) screening.
• The subject has a significant skin condition (i.e., hemangioma, scleroderma, psoriasis, rash, open wound or tattoo) on the subject's scalp that is found to be in proximity to any of the procedure sites.
• The subject has an implant of any kind in the head (e.g. stent, clipped aneurysm, 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)
• Recent history of stroke (90 days).
• The subject failed a device-based intervention FDA-approved for the treatment of depression, during the current episode (e.g. less than 50% decrease in depressive symptomatology with Transcranial Magnetic Stimulation).
• History of dementia, traumatic brain injury (TBI) or any other organic neurological disorder.

Sponsors & Collaborators

• Peruvian Clinical Research: lead
• NeuroThera: collaborator

Study Sites (1)

Hospital Nacional Hipolito Unanue

Lima, 15007, Peru

RECRUITING

Related Publications (3)

• Cassano P, Petrie SR, Mischoulon D, Cusin C, Katnani H, Yeung A, De Taboada L, Archibald A, Bui E, Baer L, Chang T, Chen J, Pedrelli P, Fisher L, Farabaugh A, Hamblin MR, Alpert JE, Fava M, Iosifescu DV. Transcranial Photobiomodulation for the Treatment of Major Depressive Disorder. The ELATED-2 Pilot Trial. Photomed Laser Surg. 2018 Dec;36(12):634-646. doi: 10.1089/pho.2018.4490. Epub 2018 Oct 20.

  PMID: 30346890 BACKGROUND

• Cassano P, Cusin C, Mischoulon D, Hamblin MR, De Taboada L, Pisoni A, Chang T, Yeung A, Ionescu DF, Petrie SR, Nierenberg AA, Fava M, Iosifescu DV. Near-Infrared Transcranial Radiation for Major Depressive Disorder: Proof of Concept Study. Psychiatry J. 2015;2015:352979. doi: 10.1155/2015/352979. Epub 2015 Aug 19.

  PMID: 26356811 BACKGROUND

• Caldieraro MA, Cassano P. Transcranial and systemic photobiomodulation for major depressive disorder: A systematic review of efficacy, tolerability and biological mechanisms. J Affect Disord. 2019 Jan 15;243:262-273. doi: 10.1016/j.jad.2018.09.048. Epub 2018 Sep 17.

  PMID: 30248638 BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• William Aguilar Rivera, Dr.

  Hospital Nacional Hipolito Unanue

  PRINCIPAL INVESTIGATOR

• Beatrice Macciotta Felices, Dr.

  Clinica Vesalio

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raúl Yepez Adrianzén, Dr.

CONTACT

+51 999962145; r.yepez@pcr.pe

Paula Cahuina Lope, Dr.

CONTACT

+51 923403150; medicalaffairs@pcr.pe

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2022
• First Posted: June 28, 2022
• Study Start: July 1, 2022
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: September 28, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

PE (1)