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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

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

Trial sites (1)

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