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

Not Applicable

Recruiting

• Conditions: Major Depressive Disorder (MDD)

• Registration Number: NCT06922812
• Lead Sponsor: University of Sao Paulo

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 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.

Study Timeline

• Study First Submitted: 2025-04-03
• Study First Submitted QC: 2025-04-03
• Study First Posted: 2025-04-11
• Status Verified: 2025-05
• Study Start: 2025-05-05
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-23
• Primary Completion: 2025-11-01
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Change in Depression Severity as Measured by HDRS-17	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.

Trial Locations

Locations (1)

University of São Paulo; 🇧🇷 São Paulo, SP, Brazil