NCT06922812

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of Sao Paulo · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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 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.

Detailed description

This is an open-label pilot study evaluating the safety, tolerability, and preliminary efficacy of Intermittent White Light Stimulation (IWLS) in individuals with moderate to severe Major Depressive Disorder. The intervention consists of 10 sessions over two weeks, with follow-up at weeks 4 and 6. The study aims to gather data to support future randomized controlled trials using IWLS for depression.

Conditions

• Major Depressive Disorder (MDD)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-05-05
• Primary completion: 2025-11-01
• Completion: 2026-05-30
• First posted: 2025-04-11
• Last updated: 2026-02-23

Locations

1 site across 1 country: Brazil