Escitalopram and Sleep Architecture in Patients With Major Depressive Disorder
试验速览
- 阶段
- 4 期
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Change in latency of the first REM episode of the night.
研究概览
简要总结
The purpose of this study is to assess the effect of escitalopram on sleep architecture utilizing a prospective design.
Hypothesis: Escitalopram will improve REM latency in patients with MDD that have responded clinically to treatment.
详细描述
Disturbance of sleep is a prominent symptom in depressive disorders. Alterations of sleep patterns in depressed patients include insomnia, frequent awakenings, early wake-up and non-refreshing sleep. Polysomnographic recordings have confirmed these reports, reporting reduced latency of the first REM episode of the night, with decreased density of rapid eye movements, and enhancement of total percentage of REM sleep, a reduction of deep slow wave sleep (SWS) and increase in night awakenings (Benca et al., Classification of sleep disorders).
The effects of antidepressant drugs on depression and sleep disorders, specifically SSRIs, have been thoroughly researched. The effects of escitalopram on sleep in depressed patients have been reported using a retrospective design, and in this proposed protocol, we suggest to assess the effect of escitalopram on sleep architecture utilizing a prospective design.
Hypothesis
Escitalopram will improve REM latency in patients with MDD that have responded clinically to treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients suffering from MDD, excluding a depressive episode of Bipolar Disorder.
- •The depressive episode is not secondary to a general medical condition or substance abuse.
- •Ages between 18-65 years old.
- •Patients receiving other medications must be on a stable dosage for one month before entering the trial, including hypnotics.
- •Able to understand and sign an informed consent form.
排除标准
- •Patients suffering from sleep disturbances due to a physical condition (COPD, sleep apnea or essential insomnia preceding the diagnosis of depression).
- •Patients suffering from an unstable clinically significant medical condition (cardiovascular, endocrine, nutritional, hepatic, urinary).
- •Patients suffering from a malignancy or neuro-degenerative such as Parkinsons' disease
- •Patients suffering from a clinically significant psychiatric psychotic disease, as judged by DSM-IV criteria, such as schizophrenia or acute psychosis.
- •Patients experiencing severe withdrawal symptoms following a discontinuation of hypnotic drugs, upon entry into the baseline phase.
- •History of drug or alcohol dependence within the last year.
结局指标
主要结局
Change in latency of the first REM episode of the night.
次要结局
- Density of rapid eye movements
- Changes of total percentage of REM sleep
- Changes in deep slow wave sleep (SWS)
- Number of night awakenings