40 Hz Light Neurostimulation for Patients With Depression (FELIX)

Launched by KLAUS MARTINY · Jan 8, 2023

Keywords

ClinConnect Summary

The FELIX clinical trial is exploring the use of 40 Hz light therapy as a potential treatment for people with Major Depressive Disorder (MDD) who have not responded well to other treatments. Researchers believe that this type of light stimulation could help improve mood and brain function by encouraging the brain to make new connections and reducing inflammation. Participants in the study will spend one hour each day at home exposed to either the flickering light (the active treatment) or a non-flickering white light (the control) for a total of six weeks.

To join the trial, you need to be between 18 and 75 years old and currently experiencing a major depressive episode. You should also be on stable medication or therapy for at least four weeks before starting the study. However, there are some exclusions, like having certain eye disorders, a history of severe mental health issues, or being pregnant. If you qualify and choose to participate, you'll be asked to follow a set schedule and use the light device as instructed. This trial offers a chance to contribute to new research that could help others struggling with depression.

Gender

ALL

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