NCT05680220Recruiting
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
Source: ClinicalTrials.gov · Last updated 3 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 3 Jan 2023
- Start date
- 5 Oct 2023
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Klaus Martiny
- Diseases
- Depression
- NCT number
- NCT05680220
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 5 Oct 2023 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subjects with current psychotic symptoms. However, subjects with a prior psychotic depression or subjects with an actual psychotic depression episode that at the time of informed consent no longer fulfills the psychosis criteria are allowed to participate.
- Subjects with current drug or alcohol dependence based on their medical records or the M.I.N.I. interview.
Other illness
- Subjects with a history of photosensitive migraines and/or epileptic seizures
- Subjects with a known eye disorder that might be sensitive to light treatment.
- Subjects with a known history of bipolar disorder according to DSM-5 criteria
- Subjects with a known history of borderline personality disorder
- Subjects with progressive neurodegenerative or neoplastic disease.
Age
- Subjects who are pregnant at the time of inclusion or unsafe contraception in women of fertile age
Other
- Subjects with suicidal ideation corresponding to a score of 2 or more on the HAM-D 17 scale item 3 or if the patient or investigator is uncertain of the degree of suicidal risk
- Subjects currently enrolled in another investigational treatment study.
- Subjects who are unable to understand the study procedures or handling of the NSS device.
Who the study is looking for
- Subjects between 18 and 75 years of age.
- Subjects with a diagnosis of major depressive episode and currently experiencing a depressive episode according to DSM-5
- Subjects with an MDI score \> 21 at screening
- Subjects on stable medication and/or psychotherapy for at least 4 weeks before starting the trial.
- Subjects, who are willing to comply with the scheduled plan and are able to use the device for 1 hour per day for 6 weeks.
- Subjects who can understand the oral and written study information and willing to sign an informed consent.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mental Health Centre Copenhagen Coordinator of this site? Confirm its status | Copenhagen | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.