Efficacy of Chronotherapeutic Combination for Major Depressive Episode With Insomnia
报名条件（概要）
- 年龄：18 Years – 65 Years
- 性别：不限
- 健康志愿者：不接受
完整入排标准请以官方页面为准。
开展国家/地区
France
药品与企业信息
Patients will receive an SSRI antidepressant (e.g., Fluoxetine, Sertraline, Paroxetine, Escitalopram) or SNRI (e.g., Venlafaxine, Duloxetine) antidepressant (as clinically appropriate), combined with sleep hygiene education, daily morning LT (10,000 lux for 30 minutes between 7-8 a.m. using the Dayvia Slim Style 3 lamp), and 2 mg of extended-release melatonin taken one hour before bedtime, all for a duration of 8 weeks.
Patients will receive an SSRI or SNRI, sleep hygiene instructions, daily morning bright LT (10,000 lux, 30 cm, 30 min, 7-8 a.m., using Dayvia Slim Style 3 lamps), and placebo melatonin taken one hour before bedtime, all for a duration of 8 weeks.
Patients will receive an SSRI or SNRI, sleep hygiene instructions, daily placebo light exposure (\<10 lux, 30 cm, 30 min, 7-8 a.m., using Dayvia Slim Style 3 lamps in non-therapeutic mode), and 2 mg of extended-release melatonin taken one hour before bedtime, all for a duration of 8 weeks.
Patients will receive an SSRI or SNRI, sleep hygiene instructions, daily placebo light exposure (\<10 lux, 30 cm, 30 min, 7-8 a.m., using Dayvia Slim Style 3 lamps), and oral placebo melatonin taken one hour before bedtime, all for a duration of 8 weeks.
研发企业
试验官方登记的主要申办方；研究机构申办时会显示相应机构名称。
生产企业
公开药品批准资料或正式说明书暂未提供明确的生产企业信息。
研发企业与生产企业可能不是同一家。研究阶段药品可能尚未公布生产企业；生产企业仅取自美国上市原研药说明书所列企业（不含仿制药），不作推测；仅在其他国家上市的药品暂无法显示。
研究简介（原文）
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.
适应症
主动联系研究团队
这项试验目前在中国大陆没有研究中心
这种情况下，直接发"入组咨询"往往会被回复"您所在地区没有中心"。更有效的做法是申请同情用药／扩展准入（由主治医生一同提出），或询问能否到最近的境外中心参加。下面已为您切换到对应的信件版本。
查看完整申请路径与成功率说明 →总联系人（申办方／研究总部）
- Pierre-Alexis GEOFFROY, Pr, medpierrealexis.geoffroy@aphp.fr+33 1 40 25 62 72
- Julia MARUANI, Dr, medjulia.maruani@aphp.fr+33 1 40 25 62 72
研究中心联系方式
- Hôpital Bichat-Claude BernardParis，France
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英文版（发给研究团队）
Dear Study Team, I am a patient in China and I am interested in participating in your clinical trial: Study Title: Efficacy of Chronotherapeutic Combination for Major Depressive Episode With Insomnia ClinicalTrials.gov Identifier: NCT07120880 Sponsor: Assistance Publique - Hôpitaux de Paris Investigational product: AD + SHR + active LT and extended-release melatonin 2mg, AD + SHR + active LT and placebo melatonin, AD + SHR + placebo LT and extended-release melatonin 2mg, AD + SHR + placebo LT and placebo melatonin About me: - Age: (please fill in) - Sex: (please fill in) - Confirmed diagnosis and stage: (please fill in) - Biomarkers / genetic testing: not available - Prior and current treatments: (please fill in) - Performance status (ECOG): not assessed - Current location: China - Travel ability: (please fill in) Could you please let me know: 1. Whether I might be eligible for this study; 2. Which site would be closest and most practical for me, and whether remote pre-screening is possible; 3. What documents (medical records, pathology or imaging reports, recent labs) I should prepare for pre-screening. I can provide English translations of my medical records. Thank you very much for your time and help. Kind regards, (your name) (your email / phone with country code)
中文对照（供您核对）
尊敬的研究团队： 我是一位来自中国的患者，希望咨询参加以下临床试验的可能： 研究名称：Efficacy of Chronotherapeutic Combination for Major Depressive Episode With Insomnia 试验编号：NCT07120880 申办方：Assistance Publique - Hôpitaux de Paris 研究药物：AD + SHR + active LT and extended-release melatonin 2mg、AD + SHR + active LT and placebo melatonin、AD + SHR + placebo LT and extended-release melatonin 2mg、AD + SHR + placebo LT and placebo melatonin 我的基本情况： - 年龄：（请填写） - 性别：（请填写） - 确诊疾病与分期：（请填写） - 基因／标志物检测：暂无 - 既往及当前治疗：（请填写） - 体能状态（ECOG）：未评估 - 目前所在城市：中国 - 可前往范围：（请填写） 想请教三个问题： 1. 我是否可能符合本研究的入组标准？ 2. 哪个中心对我最方便可行？能否远程预筛？ 3. 预筛需要准备哪些资料（病历、病理、影像、近期化验）？ 我可以提供英文翻译版病历。感谢您的时间与帮助。 顺祝安康 （您的姓名） （您的邮箱／带国际区号的电话）
提示：请与主治医生一起发信——由医生署名的申请，回复率远高于患者单独发信。首封邮件不要附身份证号等敏感信息。研究团队通常在 3–10 个工作日内回复，两周无回音可礼貌追问一次。
下一步怎么做？
- 把本页信息带给您的主治医生，评估是否适合参加。
- 点击下方按钮打开官方注册页，查看研究中心联系方式。
- 直接联系研究团队咨询报名事宜（通常有中文同声翻译服务可协助沟通）。