- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05435820
Near-infrared Transcranial Laser Therapy in Subjects With Major Depressive Disorder: A Study of Dosing With Laser
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Raúl Yepez Adrianzén, Dr.
- Phone Number: +51 999962145
- Email: r.yepez@pcr.pe
Study Contact Backup
- Name: Paula Cahuina Lope, Dr.
- Phone Number: +51 923403150
- Email: medicalaffairs@pcr.pe
Study Locations
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Lima, Peru, 15007
- Recruiting
- Hospital Nacional Hipólito Unanue
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Contact:
- Martha Celis Llerena, Bach.
- Phone Number: (+51) 997077107
- Email: marjecelle@yahoo.com
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Contact:
- Elizabeth Valdivia Márquez, Dr.
- Phone Number: (+51) 979181614
- Email: evaldiviamarquez@gmail.com
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Principal Investigator:
- William Aguilar Rivera, Dr.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BCW group
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) |
The treatment consists in exposing bilaterally the frontal brain to Transcranial Laser Therapy, which may enhance ATP production in depressed subjects.
|
Experimental: BPW-1 group
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) |
The treatment consists in exposing bilaterally the frontal brain to Transcranial Laser Therapy, which may enhance ATP production in depressed subjects.
|
Experimental: BPW-2 group
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) |
The treatment consists in exposing bilaterally the frontal brain to Transcranial Laser Therapy, which may enhance ATP production in depressed subjects.
|
Sham Comparator: SHAM group
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 |
The treatment consists in exposing bilaterally the frontal brain to Transcranial Laser Therapy, which may enhance ATP production in depressed subjects.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in the scores of the Hamilton Depression Rating Scale (HAMD-17) from baseline to week 3 and week 6.
Time Frame: From baseline to week 3 and week 6.
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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.
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From baseline to week 3 and week 6.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in the scores of the Quick Inventory of Depressive Symptomatology-Clinician Rated Scale (QIDS-CR) from baseline to week 3 and week 6.
Time Frame: From baseline to week 3 and week 6.
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The antidepressant effects of NIR-TLT doses will be measured using the QIDS-CR.
This is a brief (16-item) clinician-rated inventory of core depressive symptoms such as sleep, depressed mood, appetite, concentration, suicidal ideation, interest, energy, psychomotor retardation, or agitation.
The range score is 0 to 27.
Higher scores represent greater severity of depression.
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From baseline to week 3 and week 6.
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Changes in the scores of the Clinical Global Impressions - Severity (CGI-S) from baseline to week 3 and week 6.
Time Frame: From baseline to week 3 and week 6.
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The antidepressant effects of NIR-TLT doses will be measured using the CGI-S.
The CGI-S is one of the two components of the CGI test.
This tool asks the clinician one question: "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?"
which is rated on the following seven-point scale: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients.
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From baseline to week 3 and week 6.
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Changes of electroencephalogram (EEG) espectral power from baseline to week 3 and week 6.
Time Frame: From baseline to week 3 and week 6.
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To compare the effects of NIR-TLT doses on brain electrophysiology, changes in EEG spectral power in all spectral bands for each dose will be analyzed.
The waves that will be considered are alpha, theta, and delta.
For all of them, frequency and amplitude will be registered.
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From baseline to week 3 and week 6.
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Changes in the scores of the Systemic Assessment for Treatment Emergent Events (SAFTEE-SI) from baseline to week 3 and week 6.
Time Frame: From baseline to week 3 and week 6.
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To compare the safety and tolerability of NIR-TLT doses, mean changes in SAFTEE-SI scores will be analyzed.
This is a questionnaire developed for psychiatric trials.
The SAFTEE-SI allows ratings of five levels of severity and collects information about the onset, duration, pattern, judgment of attribution of cause, and action taken by the clinician when an Adverse Event happens.
The range score is 0 to 128.
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From baseline to week 3 and week 6.
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Brain metabolism effect of NIR-TLT dose (exploratory assessment) from baseline to week 6.
Time Frame: From baseline to week 6.
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The analysis of the results obtained in the PET will be for exploratory purposes to study the brain metabolism of the participants, before and at the end of the study intervention in the 4 groups.
The cortical regions that will be analyzed are the prefrontal lateral and prefrontal medial regions (right and left for both).
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From baseline to week 6.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: William Aguilar Rivera, Dr., Hospital Nacional Hipólito Unanue
- Principal Investigator: Beatrice Macciotta Felices, Dr., Clinica Vesalio
Publications and helpful links
General Publications
- 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.
- 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.
- 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. Review.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NITLT01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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