Major Depressive DisorderNCT05435820
Near-infrared Transcranial Laser Therapy in Subjects With Major Depressive Disorder: A Study of Dosing With Laser
A study testing Near-infrared Transcranial Laser Therapy in people with Major Depressive Disorder and Depression Disorders, run by Peruvian Clinical Research at 3 sites in Peru.
Trial summary
Note: This registration is retained as a historical study record. Updated study information and subsequent protocol modifications are available under ClinicalTrials.gov Identifier NCT06934135, which serves as the actively maintained study registration. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Major Depressive Disorder, Depression Disorders
- What is being tested?
- Near-infrared Transcranial Laser Therapy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 3 sitesPeru
- Study dates
- 1 Jul 2022to 30 May 2026
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
3 sites in 1 country.
Peru3 sites
Hospital Nacional Hipolito Unanue
Lima, Lima Province, 15007
Hospital Nacional Guillermo Almenara Irigoyen
Lima, Lima Province, 15034
Clinica Vesalio
Lima, Lima Province, 15037
About this study
Note: This registration is retained as a historical study record. Updated study information and subsequent protocol modifications are available under ClinicalTrials.gov Identifier NCT06934135, which serves as the actively maintained study registration.
The Near-Infrared Transcranial Laser Therapy (NIR-TLT) is a non-invasive intervention that delivers near-infrared light to brain tissue. Photobiomodulation is believed to interact with cytochrome c oxidase, a mitochondrial enzyme involved in cellular energy metabolism, resulting in increased adenosine triphosphate (ATP) production and potential neuroprotective effects.
These mechanisms may promote cellular plasticity and support improvement of depressive symptoms. This study evaluates the safety, tolerability, and potential antidepressant effects of NIR-TLT in adults with Major Depressive Disorder.
Read the detailed description
Study purpose: To assess and compare the effect(s) of each of the four doses of NIR-TLT on symptomatology of depression: antidepressant effect, in subjects with major depressive disorder (MDD). To assess the safety and tolerability of each dose of NIR-TLT. Compare the effect(s) of each of the four doses of NIR-TLT in brain electrophysiology. To describe the findings visualized in PET, related to the cerebral metabolism of the participants, before and after receiving the intervention under study. Study design: This protocol is a multicentered, randomized, simulated, and double-blind clinical study. This work will randomize 112 subjects into 4 equal groups: bilateral continuous wave (BCW), bilateral pulsed wave (BPW 1-2) y SHAM. All subjects, investigators (except the study statistician), and outcomes assessors will be blind to group assignment. The device operator will be aware of group assignments. All subjects will receive 3 NIR-TLT treatments per week for 6 weeks. A follow-up evaluation will be performed 2 weeks after the end of the study. The treatment will follow these specifications: wavelength 830 nm; average irradiance 54,8 mW / cm2; average fluence of 65,8 J / cm2 (consistently with parameters used in the ELATED-2 study at MGH with the device Omnilux New U), being the total Fluency delivered: 3.6 kJ (bilateral) o 1.8 kJ (unilateral), either on the subject's forehead, at or near electroencephalography sites (EEG) F3 and F4. All NIR-TLT sessions will last 20 minutes, regardless of group assignment. Study population: Patients eligible for study participation will be diagnosed with major depressive disorder (MDD) by DSM criteria. Subjects will be between 18-75 years of age (have not had 76st birthday) on the date of screening. Duration of participation: Subjects will be followed in the study for 8 weeks (a 6-week treatment period, plus 2 weeks of follow-up). The total duration of the study will be 24 months. Assessment criteria: The primary efficacy criteria is the improvement in depressive symptoms from each of the four doses of NIR-TLT. Assessed using HAMD-17, at 3 time points (visit 1, visit 9 and visit 18).
- Conditions
- Major Depressive Disorder, Depression Disorders
- Being tested
- Near-infrared Transcranial Laser Therapy
- Keywords
- Near-infrared transcranial laser therapy, Hamilton Depression rating scale, Major depressive Disorder, Clinical trial
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near-infrared Transcranial Laser TherapyDevice
The treatment consists in exposing bilaterally the frontal brain to Transcranial Laser Therapy, which may enhance ATP production in depressed subjects.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: 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) Receives: 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 Receives: Device: Near-infrared Transcranial Laser Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: From baseline to week 3 and week 6.
Changes of electroencephalogram (EEG) espectral power from baseline to week 3 and week 6.
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.
Measured: 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.
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.
Measured: From baseline to week 3 and week 6.
Brain metabolism effect of NIR-TLT dose (exploratory assessment) from baseline to week 6.
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).
Measured: From baseline to week 6.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start1 Jul 2022
- Primary completion30 May 2026
- Study completion30 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peruvian Clinical Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William Aguilar Rivera, Dr., Principal investigator, Hospital Nacional Hipolito UnanueBeatrice Macciotta Felices, Dr., Principal investigator, Clinica VesalioJeff Huarcaya, Dr., Principal investigator, Hospital Nacional Guillermo Almenara Irigoyen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05435820
- Sponsor's protocol ID
- NITLT01
- Status last verified
- May 2026
- First submitted
- 8 Jun 2022
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: After the completion of the study, the researchers will decide if IPDs can be shared. The data will first be sent to the regulatory institutions involved.
Publications
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.
PubMed 30346890Cassano 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.
PubMed 26356811Caldieraro 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.
PubMed 30248638
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Near-infrared Transcranial Laser Therapy in Subjects With Major Depressive Disorder: A Study of Dosing With Laser
- ClinicalTrials.gov ID
- NCT05435820
- Acronym / sponsor ID
- NITLT01
- Conditions
- Major Depressive Disorder, Depression Disorders
- Keywords
- Near-infrared transcranial laser therapy, Hamilton Depression rating scale, Major depressive Disorder, Clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Peruvian Clinical ResearchUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 May 2026 (actual)
- Study completion
- 30 May 2026 (actual)
- First posted
- 28 Jun 2022 (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.
Note: This registration is retained as a historical study record. Updated study information and subsequent protocol modifications are available under ClinicalTrials.gov Identifier NCT06934135, which serves as the actively maintained study registration.
The Near-Infrared Transcranial Laser Therapy (NIR-TLT) is a non-invasive intervention that delivers near-infrared light to brain tissue. Photobiomodulation is believed to interact with cytochrome c oxidase, a mitochondrial enzyme involved in cellular energy metabolism, resulting in increased adenosine triphosphate (ATP) production and potential neuroprotective effects.
These mechanisms may promote cellular plasticity and support improvement of depressive symptoms. This study evaluates the safety, tolerability, and potential antidepressant effects of NIR-TLT in adults with Major Depressive Disorder.
Detailed description
Study purpose: To assess and compare the effect(s) of each of the four doses of NIR-TLT on symptomatology of depression: antidepressant effect, in subjects with major depressive disorder (MDD). To assess the safety and tolerability of each dose of NIR-TLT. Compare the effect(s) of each of the four doses of NIR-TLT in brain electrophysiology. To describe the findings visualized in PET, related to the cerebral metabolism of the participants, before and after receiving the intervention under study. Study design: This protocol is a multicentered, randomized, simulated, and double-blind clinical study. This work will randomize 112 subjects into 4 equal groups: bilateral continuous wave (BCW), bilateral pulsed wave (BPW 1-2) y SHAM. All subjects, investigators (except the study statistician), and outcomes assessors will be blind to group assignment. The device operator will be aware of group assignments. All subjects will receive 3 NIR-TLT treatments per week for 6 weeks. A follow-up evaluation will be performed 2 weeks after the end of the study. The treatment will follow these specifications: wavelength 830 nm; average irradiance 54,8 mW / cm2; average fluence of 65,8 J / cm2 (consistently with parameters used in the ELATED-2 study at MGH with the device Omnilux New U), being the total Fluency delivered: 3.6 kJ (bilateral) o 1.8 kJ (unilateral), either on the subject's forehead, at or near electroencephalography sites (EEG) F3 and F4. All NIR-TLT sessions will last 20 minutes, regardless of group assignment. Study population: Patients eligible for study participation will be diagnosed with major depressive disorder (MDD) by DSM criteria. Subjects will be between 18-75 years of age (have not had 76st birthday) on the date of screening. Duration of participation: Subjects will be followed in the study for 8 weeks (a 6-week treatment period, plus 2 weeks of follow-up). The total duration of the study will be 24 months. Assessment criteria: The primary efficacy criteria is the improvement in depressive symptoms from each of the four doses of NIR-TLT. Assessed using HAMD-17, at 3 time points (visit 1, visit 9 and visit 18).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BCW group | Experimental | Device: Near-infrared Transcranial Laser TherapyNIR-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) |
| BPW-1 group | Experimental | Device: Near-infrared Transcranial Laser TherapyNIR-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) |
| BPW-2 group | Experimental | Device: Near-infrared Transcranial Laser TherapyNIR-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) |
| SHAM group | Sham comparator | Device: Near-infrared Transcranial Laser TherapyNIR-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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
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 |
|---|---|---|
| Near-infrared Transcranial Laser TherapyThe treatment consists in exposing bilaterally the frontal brain to Transcranial Laser Therapy, which may enhance ATP production in depressed subjects. | Device | BCW group, BPW-1 group, BPW-2 group, SHAM group |
Primary outcome
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.
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.
5 secondary outcomes
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.
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.
Changes of electroencephalogram (EEG) espectral power from baseline to week 3 and week 6.
Time frame: 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.
Time frame: From baseline to week 3 and week 6.
Brain metabolism effect of NIR-TLT dose (exploratory assessment) from baseline to week 6.
Time frame: From baseline to week 6.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Background: PubMed 30346890Cassano 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.
- Background: PubMed 26356811Cassano 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.
- Background: PubMed 30248638Caldieraro 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.
- Individual participant dataSharing planned: No. After the completion of the study, the researchers will decide if IPDs can be shared. The data will first be sent to the regulatory institutions involved.
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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.
William Aguilar Rivera, Dr. principal investigator
Hospital Nacional Hipolito Unanue
Beatrice Macciotta Felices, Dr. principal investigator
Clinica Vesalio
Jeff Huarcaya, Dr. principal investigator
Hospital Nacional Guillermo Almenara Irigoyen
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Near-infrared Transcranial Laser Therapy in people with Major Depressive Disorder and Depression Disorders, run by Peruvian Clinical Research at 3 sites in Peru.
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 8 inclusion and 15 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: finished, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Peru. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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.). 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 NCT05435820, which also lists 3 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 2 Jul 2026.