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

N/AActive Not RecruitingNCT06922812

University of Sao Paulo30 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. 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.

Outcomes

Primary Outcomes

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.

Time frame: 6 weeks

Secondary Outcomes

Change in Depression Severity as Measured by HDRS-17

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.

Time frame: Baseline, Day 12, Day 40