RecruitingNot ApplicableNCT05680220

40 Hz Light Neurostimulation for Patients With Depression (FELIX)

A Double-blinded, Randomized Placebo-controlled Trial of 40 Hz Light Neurostimulation Therapy for Patients With Depression


Sponsor

Klaus Martiny

Enrollment

60 participants

Start Date

Oct 5, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Recent research in mice models of Alzheimer's disease (AD) has demonstrated that one hour per day of exposure to 40 Hz flickering light therapy can halt the disease's progression, and improve cognition and memory. Moreover, recent data suggest that 40 Hz light stimulation may induce neuroplasticity and reduce neuroinflammation. In this study, the investigators aim to evaluate the antidepressant effects of 40 Hz light stimulation in Major Depressive Disorder (MDD). Patients will be exposed to 40 Hz invisible spectral flickering light (active setting) or continuous non-flickering white light (sham setting) in a home setting for 1 hour each day.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study — called FELIX — is testing whether a light therapy device that delivers flickering 40 Hz light stimulation can help reduce symptoms of depression when used at home for 1 hour a day over 6 weeks. The therapy works by stimulating brain activity at a specific frequency linked to improved brain function. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with major depression and are currently experiencing a depressive episode - Your depression score meets the required severity threshold - You have been on stable medication or therapy for at least 4 weeks before starting the trial - You are able and willing to use the device for 1 hour per day for 6 weeks **You may NOT be eligible if...** - You have a history of photosensitive migraines or epileptic seizures - You have a known eye disorder that could be worsened by light - You have bipolar disorder or current psychotic symptoms - You have active suicidal thoughts - You have a current drug or alcohol dependence - You have a history of borderline personality disorder - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICENeurostimulation System (NSS): Active Setting

Exposure to the active device for 1 hour a day for 6 weeks

DEVICENeurostimulation System (NSS): Sham Setting

Exposure to the sham device for 1 hour a day for 6 weeks


Locations(1)

Mental Health Centre Copenhagen

Copenhagen, Denmark, Denmark

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NCT05680220


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