Can morning light and melatonin double the power of antidepressants?
NCT ID NCT07120880
First seen Aug 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time
Summary
This trial tests whether adding two 'chronotherapeutics'—bright light therapy in the morning and a slow-release melatonin pill at night—to standard antidepressants can better ease depression in adults who also have insomnia. About 184 people with major depression and sleep problems will receive these add-ons, alone or together, for 8 weeks. The goal is to see if this combination reduces depressive symptoms more than antidepressants alone, potentially offering a new strategy for the many patients who don't fully respond to medication.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Light therapy (10,000 lux for 30 minutes each morning) and extended-release melatonin 2 mg, taken one hour before bedtime, added to standard antidepressant treatment and sleep hygiene education.
- What this could lead to
- If effective, this combination could offer a simple, drug-adjacent way to boost antidepressant response and improve sleep, potentially helping the many people with depression who don't fully recover with medication alone.
- What could go wrong
- This is a mid-stage trial, so results may not hold up in larger, real-world settings. Light therapy carries a small risk of eye strain or headache, and melatonin may cause drowsiness or dizziness.
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 184 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Jan 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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. Adults aged between 18 and 65 years (to avoid the risk of cataract associated with light therapy) with a diagnosis of a major depressive episode (MDE) in the context of unipolar depression (according to DSM-5 criteria). 2. Diagnosis of comorbid insomnia with the MDE, defined by difficulty initiating sleep, and/or maintaining sleep, and/or early morning awakenings with daytime consequences, occurring at least three times per week (according to DSM-5 and ICSD-3, in line with European guideline recommendations). 3. Outpatients or inpatients treated for MDE in one of the psychiatric departments of the study centers, or in the sleep medicine department, for a minimum treatment duration of 8 weeks. 4. Patients not currently receiving antidepressant treatment for the current MDE (previous use of antidepressants is allowed, provided treatment was stopped at least one month prior to study participation). 5. A MADRS score ≥ 20 (clinician-rated), indicating at least a moderate-intensity depressive episode. 6. An ISI score ≥ 8 (clinician-rated), indicating at least mild and clinically significant insomnia. 7. No exposure to light therapy in the month prior to inclusion. 8. Ability to understand and sign the informed consent form. 9. Use of highly effective contraception for women of childbearing potential. Exclusion Criteria: 1. Individuals under legal guardianship or deprived of liberty 2. Ophthalmologic conditions (e.g., cataract, glaucoma, age-related macular degeneration) or diseases affecting the retina (e.g., retinitis pigmentosa, diabetes, herpes, etc.) 3. The following disorders (according to DSM-5): schizophrenia and other psychotic disorders; bipolar disorder, particularly (hypo)manic episodes (YMRS score ≥ 12); other unstable mental disorders 4. Other unstable general medical conditions 5. Pregnant or breastfeeding women 6. Hypersomnia with prolonged total sleep time secondary to the depressive episode, according to ICSD-3 criteria 7. Current depressive episode already being treated with an antidepressant 8. Presence of a high suicidal risk, as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS, score ≥ 4) 9. Ongoing melatonin treatment at the time of inclusion
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Conditions
The condition(s) this trial relates to.
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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Hôpital Bichat-Claude Bernard
RECRUITINGParis, 75018, France