Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT05680220

40 Hz Light Neurostimulation for Patients With Depression (FELIX)

Led by Klaus Martiny · Updated on 2026-03-03

60

Participants Needed

1

Research Sites

199 weeks

Total Duration

On this page

Sponsors

K

Klaus Martiny

Lead Sponsor

T

Technical University of Denmark

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

40 Hz Light Neurostimulation for Patients With Depression (FELIX)

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Between 18 and 75 years old
  • Diagnosed with a major depressive episode and currently experiencing depression according to DSM-5
  • Major Depression Inventory (MDI) score greater than 21 at screening
  • On stable medication and/or psychotherapy for at least 4 weeks before starting the trial
  • Willing and able to use the light device for 1 hour daily for 6 weeks
  • Able to understand study information and willing to sign informed consent
Not Eligible

You will not qualify if you...

  • History of photosensitive migraines or epileptic seizures
  • Known eye disorders sensitive to light treatment
  • History of bipolar disorder according to DSM-5
  • Suicidal ideation with a score of 2 or more on HAM-D 17 item 3, or uncertain suicidal risk
  • Current psychotic symptoms (except prior or resolved psychotic depression)
  • Current drug or alcohol dependence
  • History of borderline personality disorder
  • Currently enrolled in another investigational treatment study
  • Progressive neurodegenerative or cancerous disease
  • Unable to understand study procedures or device use
  • Pregnant or unsafe contraception in women of fertile age

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Mental Health Centre Copenhagen

Copenhagen, Denmark, Denmark, 2100

Actively Recruiting

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Research Team

K

Klaus Martiny

CONTACT

M

Malina Ploug Larsen

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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