Chronotherapy plus light therapy and melatonin for major depressive episode with insomnia

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 Phase 3, interventional trial investigates a chronotherapy approach for adults with a unipolar major depressive episode complicated by insomnia. Participants are randomized to receive combinations of light therapy and extended-release melatonin (2 mg) or placebos, alongside standard antidepressant care where applicable. The study targets rapid improvements in depressive symptoms and sleep quality by stabilizing circadian rhythms. Eligibility requires adults 18-65 with DSM-5 confirmed MDE and comorbid insomnia, a MADRS score of 20 or higher, and no current antidepressant treatment for the current episode. Primary outcomes likely include changes in depressive symptoms and sleep measures over a defined treatment period.

Why it matters

Who can join: the full rules

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

Where it's running

• Hôpital Bichat-Claude Bernard
  Paris, France Recruiting

Study contacts

• Principal investigator: Pierre-Alexis GEOFFROY, Pr — Assistance Publique - Hôpitaux de Paris
• Study coordinator: Pierre-Alexis GEOFFROY, Pr, med
• Email: pierrealexis.geoffroy@aphp.fr
• Phone: +33 1 40 25 62 72

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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.