Light stimulation for treating major depression

Intermittent White Light Stimulation (IWLS) for the Treatment of Major Depressive Disorder: An Open-Label Pilot Study of Safety, Tolerability, and Preliminary Efficacy

This study is testing if a new light treatment can help people with major depression feel better after 10 sessions over two weeks.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: University of Sao Paulo (Academic / other)
• Locations: 1 site (São Paulo, SP)
• Trial ID: NCT06922812 on ClinicalTrials.gov

What this trial studies

This open-label pilot study evaluates the safety, tolerability, and preliminary efficacy of Intermittent White Light Stimulation (IWLS) in individuals with moderate to severe Major Depressive Disorder (MDD). Participants will undergo 10 sessions of light stimulation over two weeks, with follow-up assessments at weeks 4 and 6. The study aims to gather data that could support future randomized controlled trials using this innovative treatment approach for depression.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with a confirmed diagnosis of moderate to severe Major Depressive Disorder.

Not a fit: Patients with other psychiatric disorders, severe suicidal ideation, or certain medical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a non-invasive alternative for patients with major depression who do not respond to traditional pharmacological therapies.

How similar studies have performed: While this specific approach has not been tested in depressed patients, similar non-invasive brain stimulation techniques have shown promise in other studies.

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.

Where this trial is running

São Paulo, SP

• University of São Paulo — São Paulo, Sp, Brazil (Recruiting)

Study contacts

• Study coordinator: Andre Russowsky Brunoni, Professor

Conditions Major Depressive Disorder; open-label clinical trial; light; 60 Hz; major depression