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

Launched by UNIVERSITY OF SAO PAULO · Apr 3, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment method for people with Major Depressive Disorder (MDD) using a technique called Intermittent White Light Stimulation (IWLS). The goal is to see if this type of light therapy is safe and can help improve symptoms of depression. The study will involve 30 participants aged 18 to 65 who have been diagnosed with moderate to severe depression and have been on a stable antidepressant for at least six weeks.

During the six-week study, participants will receive light stimulation sessions five times a week for the first two weeks, with each session lasting 30 minutes. They will also have follow-up visits to track their progress. To be eligible, participants should not have other serious mental health conditions, severe suicidal thoughts, or certain medical issues that could interfere with the study. This trial is an important first step in exploring non-invasive treatments for depression, and its results may lead to more research in the future.

Gender

ALL

Eligibility criteria

• 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.