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Major Depressive Disorder (MDD) With Insomnia / AD + SHR + active LT and extended-release melatonin 2mg / AD + SHR + placebo LT and placebo melatonin · Phase 3 Trial
ClinicalTrials.gov · August 12, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a registry record describing a planned Phase 3 trial evaluating chronotherapeutic interventions (light therapy and melatonin) combined with antidepressants for major depressive disorder with comorbid insomnia. No results have been reported; the trial is actively recruiting and results are not yet available in this registry record.
Phase 3, Interventional, Randomized, Factorial, Double masking, Treatment purpose. Major Depressive Disorder (MDD) With Insomnia; age from 18 Years; to 65 Years. Intervention: A; B; C. Compared with: D — Placebo Comparator. n = 184. 1 site: France.
This is a registry record describing a planned Phase 3 trial evaluating chronotherapeutic interventions (light therapy and melatonin) combined with antidepressants for major depressive disorder with comorbid insomnia. No results have been reported; the trial is actively recruiting and results are not yet available in this registry record.
No efficacy, safety, or clinical outcome data are available to inform practice.
The source did not state who this applies to in practice.
This is a study registration describing a planned Phase 3 RCT with no reported results; the trial is actively recruiting and no outcome data are available.
As stated by the source record.
Quoted from the source exactly as published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07120880). This is a study registration, not published results. Lead sponsor: Assistance Publique - Hôpitaux de Paris. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 184 participants (ESTIMATED). Conditions: Major Depressive Disorder (MDD) With Insomnia. Interventions: PROCEDURE: AD + SHR + active LT and extended-release melatonin 2mg; PROCEDURE: AD + SHR + active LT and placebo melatonin; PROCEDURE: AD + SHR + placebo LT and extended-release melatonin 2mg; PROCEDURE: AD + SHR + placebo LT and placebo melatonin. Primary outcome measures: Assessment of the efficacy of two chronotherapeutics (LT and extended-release melatonin 2mg), alone or combined, associated to AD on depressive symptoms reduction after 8 weeks of treatment , At baseline (Week 0) and at Week 8. Brief summary: Major Depressive Disorder (MDD) affects 5% of the global population and is the second leading cause of disability worldwide. Despite the widespread use of antidepressants, 50-60% of patients do not respond adequately after 8 weeks of treatment. Insomnia, present in approximately 85% of individuals with MDD, is a frequent and persistent symptom that contributes to poor treatment outcomes. Targeting insomnia has been shown to enhance both symptom remission and functional recovery. In this context, combined therapeutic strategies are often used to optimize the antidepressant response. Among them, chronotherapeutic approaches, such as light therapy and prolonged-release melatonin, have demonstrated rapid antidepressant effects and are beneficial in regulating sleep and circadian rhythms. Light therapy shows an efficacy comparable to antidepressants and, when used in combination with them, can double treatment effectiveness. Melatonin is also recommended in the management of depression-related insomnia. This multicenter, randomized, double-blind, placebo-controlled trial with a 2x2 factorial design aims to evaluate the efficacy of two chronotherapeutic interventions, 8 weeks of active light therapy and 2 mg of prolonged-release melatonin-administered alone or in combination, on depressive symptom reduction at 8 weeks in adult patients with MDD and comorbid insomnia. The primary outcome is the change in Montgomery-Åsberg Depression Rating Scale (MADRS) score from baseline to week 8. All participants will receive antidepressant treatment and sleep hygiene education. This study proposes a novel therapeutic strategy combining pharmacological and non-pharmacological interventions to address both depression and insomnia, with the goal of improving outcomes, especially for the 40% of patients who do not adequately respond to antidepressants alone.
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