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CombiChronoS - Effectiveness of a Combination of Chronotherapeutics for the Treatment of Major Depressive Episode (MDE) with Insomnia: A Multicenter, Randomized, Double-Blind, Placebo-Controlled 2x2 Factorial Trial
EU CTIS ID: 2024-516371-32-00
What this study is testing
To evaluate the effectiveness of two chronotherapeutics, either alone or in combination, on the reduction of depressive symptoms after 8 weeks of treatment in patients with Major Depressive Episode (MDE): active light therapy for 8 weeks and 2 mg prolonged-release melatonin for 8 weeks.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1-Aged 18 to 65 years.
- 2- Diagnosed with Major Depressive Episode (MDE) in the context of a unipolar disorder (DSM-5 criteria) and a MADRS score ≥20 (threshold validated for moderate MDE).
- 3- Comorbid insomnia (DSM-5 criteria) with an ISI score ≥8 (threshold validated for mild and clinically significant insomnia).
- 4- Not exposed to antidepressants of any class in the month prior to inclusion
- 5- Not exposed to light therapy in the month prior to inclusion.
- 6- Patients receiving outpatient or inpatient care for a treatment duration of 8 weeks
You likely can't join if
- 1- Subjects under guardianship or deprived of liberty.
- 10- Participation in another interventional study during the course of the trial
- 11- Known hypersensitivity to melatonin.
- 12- Contraindication to selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs).
- 2- Ophthalmic diseases (cataracts, glaucoma, age-related macular degeneration, etc.) or diseases affecting the retina (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, such as substance use disorders, including alcohol and tobacco
See the full eligibility criteria
- 1-Aged 18 to 65 years.
- 2- Diagnosed with Major Depressive Episode (MDE) in the context of a unipolar disorder (DSM-5 criteria) and a MADRS score ≥20 (threshold validated for moderate MDE).
- 3- Comorbid insomnia (DSM-5 criteria) with an ISI score ≥8 (threshold validated for mild and clinically significant insomnia).
- 4- Not exposed to antidepressants of any class in the month prior to inclusion
- 5- Not exposed to light therapy in the month prior to inclusion.
- 6- Patients receiving outpatient or inpatient care for a treatment duration of 8 weeks
- 7- Ability to understand and sign the informed consent.
- 1- Subjects under guardianship or deprived of liberty.
- 10- Participation in another interventional study during the course of the trial
- 11- Known hypersensitivity to melatonin.
- 12- Contraindication to selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs).
- 2- Ophthalmic diseases (cataracts, glaucoma, age-related macular degeneration, etc.) or diseases affecting the retina (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, such as substance use disorders, including alcohol and tobacco
- 4- Other unstable general medical conditions.
- 5- Pregnant or breastfeeding women.
- 6- Hypersomnia with prolonged total sleep time secondary to MDE according to ICSD-3 criteria.
- 7- Therapeutic resistance of the current MDE (2 antidepressants from different classes).
- 8- Presence of a high suicide risk, assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS, score ≥ 4).
- 9- Treatment with melatonin at the time of inclusion.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.