IWLS for Major Depressive Disorder: An Open-Label Study of Safety, Tolerability, and Efficacy

NCT06922812 | Active Not Recruiting DMC

• 1 other identifier: 84990324.7.0000.0068
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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 will be recruited, with a current diagnosis of a mild major depressive episode (HDRS-17 scores between 8 and 23) and on a stable antidepressant regimen for at least six weeks.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.

Conditions

Major Depressive Disorder (MDD)

Keywords

open-label clinical trial; light; 60 Hz; major depression

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability of Intermittent White Light Stimulation (IWLS)

  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 Outcomes (1)

• Change in Depression Severity as Measured by HDRS-17

  Baseline, Day 12, Day 40

Study Arms (1)

IWLS Intervention

EXPERIMENTAL

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)

Interventions

Intermittent White Light Stimulation (IWLS) DEVICE

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.

IWLS Intervention

Eligibility Criteria

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

You may qualify if:

• Age between 18 and 65 years;
• Current diagnosis of Major Depressive Disorder (MDD), confirmed by MINI; HDRS-17 score between 8 and 23 at baseline;
• Stable antidepressant regimen for at least 6 weeks prior to enrollment;
• Able and willing to provide informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

University of São Paulo

São Paulo, São Paulo, 05403-010, Brazil

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Kallene Vidal, Doctor

  University of Sao Paulo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 3, 2025
• First Posted: April 11, 2025
• Study Start: May 5, 2025
• Primary Completion: November 1, 2025
• Study Completion (Estimated): May 30, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

BR (1)