2024-516371-32-00招募中3 期
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
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 184
- 试验地点
- 4
- 主要终点
- Montgomery-Åsberg Depression Rating Scale (MADRS) score at 8 weeks (Week 8, Visit 3 – clinical evaluation visit) adjusted for the baseline score (Week 0, Visit 0 – inclusion and randomization visit) in each of the four treatment arms
研究概览
简要总结
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.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Montgomery-Åsberg Depression Rating Scale (MADRS) score at 8 weeks (Week 8, Visit 3 – clinical evaluation visit) adjusted for the baseline score (Week 0, Visit 0 – inclusion and randomization visit) in each of the four treatment arms
Montgomery-Åsberg Depression Rating Scale (MADRS) score at 8 weeks (Week 8, Visit 3 – clinical evaluation visit) adjusted for the baseline score (Week 0, Visit 0 – inclusion and randomization visit) in each of the four treatment arms
次要结局
- 1. MADRS score at 1, 4, 8 weeks, and 3 months: o Therapeutic response (50% reduction in MADRS score). o Remission (MADRS score ≤ 10).
- 2. Subjective sleep quality at 1, 4, 8 weeks, and 3 months: sleep and sleep-wake rhythm self-questionnaires
- 3. Objective actigraphy parameters at 1, 4, and 8 weeks: o Sleep parameters: total sleep time, nocturnal awakenings (WASO), fragmentation index, sleep efficiency (total sleep time/total time in bed), time spent in bed. o Rhythm parameters: relative amplitude, stability, and variability of sleep-wake rhythms, L5 and M10 phase markers (onset of the least active 5 hours and most active 10 hours).
- 4. Subjective sleep diary parameters at 1, 4, and 8 weeks.
- 5. Slope of longitudinal evolution of the MADRS score
- 6. Time (in days) to therapeutic response (maximum assessment at 3 months).
- 7. Side effects questionnaire (PRISE-M) at 1, 4, and 8 weeks
- 8. Mood state and overall functioning questionnaires (YMRS, C-SSRS, QIDS-SR, GAG7, CGI) at 1, 4, 8 weeks, and 3 months
研究者
Pr. Pierre Alexis GEOFFROY
Scientific
Assistance Publique Hopitaux De Paris
研究点 (4)
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