A Double-blinded, Randomized Placebo-controlled Trial of 40 Hz Light Neurostimulation Therapy for Patients With Depression

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Denmark
Mental Health Centre Copenhagen
RECRUITING
Copenhagen
Contact Information
Primary
Klaus Martiny
klaus.martiny@regionh.dk
+45 38 64 71 00
Backup
Malina Ploug Larsen
malina.ploug.larsen@regionh.dk
Time Frame
Start Date: 2023-10-05
Estimated Completion Date: 2025-11
Participants
Target number of participants: 60
Treatments
Experimental: Active Neurostimulation System (NSS)
Exposure to the NSS device set to 40 Hz invisible spectral flicker 1 hour a day
Placebo_comparator: Sham Neurostimulation System (NSS)
Exposure to the NSS device set to continuous color-matched white light for 1 hour a day
Related Therapeutic Areas
Sponsors
Collaborators: OptoCeutics, Technical University of Denmark
Leads: Klaus Martiny

This content was sourced from clinicaltrials.gov