Changes of Sleep EEG Power and Melatonin Rhythm in Major Depressive Disoder: a Self-controlled, 8 Weeks Study of Treatment With Escitalopram Compared With Healthy Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 主要终点
- Sleep ratio of EEG power changes in MDD after 8 weeks treatment by escitalopram
研究概览
简要总结
The main objective was to compare the differences of PSG parameters and plasma melatonin levels before and after treatment with escitalopram for 8 weeks. Polysomnography (PSG) was detected over a night and blood samples were collected at 4 h intervals for 24 h from 13 male healthy controls and 13 male MDD patients before and after treatment with escitalopram for 8 weeks. The outcome measures included the levels of plasma melatonin, PSG parameters (include sleep architecture and power analysis) and scales.
详细描述
- Design and participants: The patients with MDD were screened from the hospital, age- and gender-matched healthy controls were recruited by advertising from the community who signed written informed consent before participation.
- Assessments: The 17-item Hamilton Depression Rating Scale (HRSD-17) , Montgomery-Asberg Depression Rating Scale (MADRS), the Clinical Global Impression-Severity scale (CGI-S), and 14-item Hamilton anxiety scale (HAMA) were assessed at baseline and after 8 weeks' treatment with escitalopram for patients with MDD. As for healthy volunteer, these measures were evaluated only once. In addition, all participants were assessed Pittsburgh Sleep Quality Index (PSQI) and Insomnia Severity Index (ISI).
- Treatment: Each patient was provided with escitalopram.
- Collection of peripheral blood samples: Test the levels of plasma melatonin at 4 h intervals for 24 h from all participants.
- Sleep and EEG recordings: The PSG of participants was evaluated for one night at baseline (all participants) and 8 weeks treatment (MDD).
- Analysis the PSG architecture and power ratio.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
changed into escitalopram in open treatment and compared to health control
入排标准
- 年龄范围
- 22 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Clinical diagnosis of MDD;
- •Hamilton Rating Scale for Depression 17-items (HRSD-17) total scores ≥ 22;
- •Male patients aged between 18 and 45 years
排除标准
- •Significant suicide risk by HRSD suicide scores > 2;
- •Accompanied with psychiatric symptoms;
- •Treated with MECT within 6 months.
研究组 & 干预措施
MDD and Health Control
MDD in open label
干预措施: Escitalopram (Drug)
结局指标
主要结局
Sleep ratio of EEG power changes in MDD after 8 weeks treatment by escitalopram
时间窗: 8 weeks
polysomnography (PSG) was detected over a night and power analysis was done.
The levels changes of plasma melatonin after 8 weeks treatment by escitalopram
时间窗: 8 weeks
Test the levels of plasma melatonin at 7 time points during 24 h in MDD.
Clinical efficacy of MDD in the treatment of escitalopram
时间窗: 8 weeks
The 17-item Hamilton Depression Rating Scale (HRSD-17) was defined a prior as the primary outcome measure .
次要结局
未报告次要终点
研究者
Xueqin Wang
Associate professor, M.D.
Peking University Sixth Hospital