40 Hz light therapy for treating depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Identifying brain biomarkers for treatment-resistant major depression using deep brain stimulation

  This study is testing if deep brain stimulation can help people with severe depression who haven't found relief from regular treatments by looking for brain signals that could predict their mood changes.

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• Using gamma oscillations to predict ketamine therapy outcomes in depression

  This study is testing if brain activity measured during ketamine treatment can help predict how well it will work for people with depression that hasn't responded to other treatments.

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• Understanding the impact of mood disorders and treatment responses

  This study is trying to learn more about how people with depression and bipolar disorder respond to treatment by talking to them weekly for up to 12 weeks to improve future care and predict how well medications might work.

  Recruiting National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT06462196

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.