Intermittent White Light Stimulation (IWLS) for the Treatment of Major Depressive Disorder: An Open-Label Study of Safety, Tolerability, and Efficacy (IWLS-MDD)

April 3, 2025 updated by: Andre R Brunoni, University of Sao Paulo

Intermittent White Light Stimulation (IWLS) for the Treatment of Major Depressive Disorder: An Open-Label Pilot Study of Safety, Tolerability, and Preliminary Efficacy

INTRODUCTION:

Depression is the most common mood disorder worldwide, with approximately 20 million adults affected in the United States in 2019. Current pharmacological treatments are not effective for all patients, often have significant side effects, and in some cases, require medical monitoring. Non-invasive brain stimulation (NIBS) techniques are emerging as a promising therapeutic alternative, offering fewer side effects. In this context, 60 Hz intermittent light stimulation may represent a promising and safe treatment option for depression. Animal studies have demonstrated that this form of stimulation can promote neuroplasticity, while studies in healthy individuals have shown the technique to be safe. However, 60 Hz intermittent light stimulation has not yet been evaluated in depressed patients in clinical trials.

METHODS:

This is an open-label study designed to assess the safety and tolerability of 60 Hz intermittent light stimulation (ILS) in individuals with moderate to severe depression. The trial will last six weeks in total, consisting of five sessions per week during the first two weeks, with one daily session (a total of 10 sessions, each lasting 30 minutes with 60 Hz white light stimulation), followed by two follow-up visits at weeks 4 and 6. Thirty patients aged 18 to 59 years with a current diagnosis of moderate to severe major depressive episode (HDRS-17 > 16) and a stable antidepressant regimen for at least six weeks will be recruited. The primary outcome will be the safety and tolerability of the device. Clinical improvement will be assessed through changes in HDRS-17 scores and other validated depression and anxiety scales.

EXPECTED RESULTS:

The results of this pilot study may advance knowledge in the field and pave the way for future placebo-controlled clinical trials.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 05403-010

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

- Age between 18 and 65 years

Current diagnosis of Major Depressive Disorder (MDD), confirmed by MINI

HDRS-17 score ≥16 at baseline

Stable antidepressant regimen for at least 6 weeks prior to enrollment

Able and willing to provide informed consent

Exclusion Criteria:

  • Diagnosis of other psychiatric disorders (e.g., bipolar disorder, psychotic disorders, OCD, ADHD, personality disorders, dementia)

Substance or alcohol use disorders

Severe suicidal ideation or psychotic symptoms

HDRS-17 score >28

Neurological or severe medical conditions

History of epilepsy, migraine, or photosensitivity

Retinal disease or cataracts

Regular use of anti-inflammatory medications or clopidogrel

Any worsening of symptoms during the trial (e.g., psychosis, HDRS >28, or suicidal ideation)

Participation in another clinical trial within the last 30 days

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IWLS Intervention
Participants in this arm will receive Intermittent White Light Stimulation (IWLS) at 60 Hz using an LED-equipped eye mask. Sessions will occur once daily (Monday to Friday) for 2 consecutive weeks, totaling 10 sessions. Each session will last 30 minutes. Follow-up assessments will be conducted at weeks 4 and 6 after the intervention period. The device used is developed by SyntropicMedical (Austria) and emits approximately 700 lux of diffuse white light delivered tangentially to the eyes.
Device: Intermittent White Light Stimulation (IWLS)
A wearable device developed by SyntropicMedical (Austria) delivers intermittent white light at 60 Hz using LED strips embedded in safety goggles. The light is diffused (approximately 700 lux) and projected tangentially to the participant's eyes. Participants will undergo 10 daily sessions (30 minutes each) over a two-week period. The intervention aims to evaluate the safety, tolerability, and potential antidepressant effects of 60 Hz visual stimulation in individuals with moderate to severe Major Depressive Disorder.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and Tolerability of Intermittent White Light Stimulation (IWLS)
Time Frame: 6 weeks
Safety and tolerability will be assessed through adverse events reported by participants during the stimulation period and follow-up, as well as dropout rates. Adverse effects such as dry eyes, headache, drowsiness, or discomfort will be recorded using a structured questionnaire. Ophthalmologic examinations will be conducted at baseline and at 6 weeks.
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Depression Severity as Measured by HDRS-17
Time Frame: Baseline, Day 12, Day 40
Depressive symptoms will be evaluated using the 17-item Hamilton Depression Rating Scale (HDRS-17). Outcomes will include change from baseline, clinical response (≥50% reduction), and remission (score <7) at Days 12 and 40.
Baseline, Day 12, Day 40

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Investigators

  • Study Director: Kallene Vidal, Doctor, University of Sao Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2025

Primary Completion (Estimated)

August 31, 2025

Study Completion (Estimated)

September 30, 2025

Study Registration Dates

First Submitted

April 3, 2025

First Submitted That Met QC Criteria

April 3, 2025

First Posted (Actual)

April 11, 2025

Study Record Updates

Last Update Posted (Actual)

April 11, 2025

Last Update Submitted That Met QC Criteria

April 3, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 84990324.7.0000.0068

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data (IPD) that underlie the results reported in this study will be shared, including data on primary and secondary outcomes, adverse events, and baseline characteristics.

IPD Sharing Time Frame

Study protocol, statistical analysis plan (SAP), informed consent form (ICF), and clinical study report (CSR) will be made available upon request.

IPD Sharing Access Criteria

Data will be available starting 6 months after publication of the primary results and will be available for a period of 5 years.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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