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Could a special light lift depression? new trial tests 40 hz therapy

NCT ID NCT05680220

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a device that shines 40 Hz flickering light can help reduce depression symptoms. Sixty adults with major depression will use the device at home for one hour each day over six weeks. Half will get the active flickering light, and half will get a sham light that does not flicker. The goal is to see if this light therapy can safely improve mood.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
40 Hz flickering light neurostimulation device
What this could lead to
If it works, this could offer a simple, non-drug option to help ease depression symptoms at home.
What could go wrong
This is a small, early-stage trial with only 60 people. The light therapy may not work better than a placebo, and results may not apply to everyone with depression.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2023

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Depressive Disorder, Treatment-Resistant major depressive disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Mental Health Centre Copenhagen

    RECRUITING

    Copenhagen, Denmark, 2100, Denmark

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