Status:

RECRUITING

40 Hz Light Neurostimulation for Patients With Depression (FELIX)

Lead Sponsor:

Klaus Martiny

Collaborating Sponsors:

Technical University of Denmark

OptoCeutics

Conditions:

Major Depressive Disorder

Treatment Resistant Depression

Eligibility:

All Genders

18-75 years

Phase:

NA

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 cognitio...

Detailed Description

Major depression is a major societal challenge worldwide and a substantial proportion of patients do not attain remission. Major depressive disorder (MDD) bears several key neurobiological similaritie...

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

Key Trial Info

Start Date :

October 5 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

July 30 2027

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT05680220

Start Date

October 5 2023

End Date

July 30 2027

Last Update

March 3 2026

Active Locations (1)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (1 locations)

1

Mental Health Centre Copenhagen

Copenhagen, Denmark, Denmark, 2100

40 Hz Light Neurostimulation for Patients With Depression (FELIX) | DecenTrialz