Status:
RECRUITING
IWLS for Major Depressive Disorder: An Open-Label Study of Safety, Tolerability, and Efficacy
Lead Sponsor:
University of Sao Paulo
Conditions:
Major Depressive Disorder (MDD)
Eligibility:
All Genders
18-65 years
Phase:
NA
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 f...
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 D...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 5 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06922812
Start Date
May 5 2025
End Date
November 30 2025
Last Update
May 30 2025
Active Locations (1)
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1
University of São Paulo
São Paulo, São Paulo, Brazil, 05403-010