40 Hz light therapy for treating depression
A Double-blinded, Randomized Placebo-controlled Trial of 40 Hz Light Neurostimulation Therapy for Patients With Depression
This study is testing if a special 40 Hz flickering light therapy can help people with Major Depressive Disorder feel better during a depressive episode.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University Hospital Bispebjerg and Frederiksberg Academic / other |
| Locations | 1 site (Copenhagen, Denmark) |
| Trial ID | NCT05680220 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of 40 Hz flickering light therapy on patients with Major Depressive Disorder (MDD) who are currently experiencing a depressive episode. Participants will receive either active 40 Hz light stimulation or a sham treatment in a home setting for one hour each day over six weeks. The study aims to assess changes in depression severity, cognitive responses, and other related symptoms, utilizing a double-blinded, randomized placebo-controlled design. The primary outcome will be measured using the Hamilton Depression Rating sub-scale scores at week 6.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with a current diagnosis of major depressive episode and a Hamilton Depression Inventory score greater than 21.
Not a fit: Patients with a history of photosensitive migraines, epilepsy, or bipolar disorder may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a novel, non-invasive treatment option for patients with treatment-resistant depression.
How similar studies have performed: While research on 40 Hz light stimulation is limited, preliminary studies in related fields suggest potential benefits, making this approach novel yet promising.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Copenhagen, Denmark
- Mental Health Centre Copenhagen — Copenhagen, Denmark, Denmark (Recruiting)
Study contacts
- Principal investigator: Klaus Martiny — Senior Consultant at Psychiatric Centre Copenhagen
- Study coordinator: Klaus Martiny
- Email: klaus.martiny@regionh.dk
- Phone: +45 38 64 71 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.