NCT05680220 40 Hz Light Neurostimulation for Patients With Depression (FELIX)
| NCT ID | NCT05680220 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Klaus Martiny |
| Condition | Major Depressive Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-10-05 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2023-10-05 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. Subjects between 18 and 75 years of age. 2. Subjects with a diagnosis of major depressive episode and currently experiencing a depressive episode according to DSM-5 3. Subjects with an MDI score \> 21 at screening 4. Subjects on stable medication and/or psychotherapy for at least 4 weeks before starting the trial. 5. 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. 6. Subjects who can understand the oral and written study information and willing to sign an informed consent. Exclusion Criteria: 1. Subjects with a history of photosensitive migraines and/or epileptic seizures 2. Subjects with a known eye disorder that might be sensitive to light treatment. 3. Subjects with a known history of bipolar disorder according to DSM-5 criteria 4. 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 5. 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. 6. Subjects with current drug or alcohol dependence based on their medical records or the M.I.N.I. interview. 7. Subjects with a known history of borderline personality disorder 8. Subjects currently enrolled in another investigational treatment study. 9. Subjects with progressive neurodegenerative or neoplastic disease. 10. Subjects who are unable to understand the study procedures or handling of the NSS device. 11. Subjects who are pregnant at the time of inclusion or unsafe contraception in women of fertile age
Contact & Investigator
Klaus Martiny
PRINCIPAL INVESTIGATOR
Senior Consultant at Psychiatric Centre Copenhagen
Frequently Asked Questions
Who can join the NCT05680220 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Major Depressive Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05680220 currently recruiting?
Yes, NCT05680220 is actively recruiting participants. Contact the research team at klaus.martiny@regionh.dk for enrollment information.
Where is the NCT05680220 trial being conducted?
This trial is being conducted at Copenhagen, Denmark.
Who is sponsoring the NCT05680220 clinical trial?
NCT05680220 is sponsored by Klaus Martiny. The principal investigator is Klaus Martiny at Senior Consultant at Psychiatric Centre Copenhagen. The trial plans to enroll 60 participants.