Randomised, Double-Blind, Parallel-Group, Placebo-Controlled, Fixed-Dose Study of Escitalopram in Combination With Two Fixed Doses of Gaboxadol Compared to Escitalopram in Major Depressive Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 490
- 试验地点
- 22
- 主要终点
- Montgomery and Åsberg Depression Rating Scale (MADRS)
研究概览
简要总结
To compare the efficacy of escitalopram fixed dose 20 mg/day in combination with fixed doses of gaboxadol (5 and 10 mg/day) versus escitalopram fixed dose 20 mg/day after 8 weeks of treatment in patients with Major Depressive Disorder
详细描述
Subjects participating in this study will be respectively randomised (1:2:2:2) to receive either:
- placebo or
- escitalopram 20 mg/day or
- escitalopram 20 mg/day in combination with gaboxadol 5 mg/day or
- escitalopram 20 mg/day in combination with gaboxadol 10 mg/day
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Clinical Diagnosis of MDD according to DSM-IV-TR criteria:
- •With reported duration of the current major depressive episode of at least 3 months
- •With MADRS total score of at least 30
排除标准
- •The patient has 1 or more of the following:
- •Any current psychiatric disorder other than MDD as defined in the DSM-IV-TR
- •Current or past history of: manic or hypomanic episode, schizophrenia, or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR
- •Any substance disorder (except nicotine and caffeine) within the previous 6 months as defined in the DSM-IV-TR
- •Presence or history of a clinically significant neurological disorder (including epilepsy)
- •Neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease, etc)
- •Any Axis II disorder that might compromise the study
- •Previous use of hallucinogenic drug
- •The patient has a significant risk of suicide according to the investigator's opinion, or has a score >=5 on item 10 (suicidal thoughts) of the MADRS, or has made a suicide attempt in the previous 12 months.
研究组 & 干预措施
Escitalopram placebo and gaboxadol placebo
干预措施: Escitalopram placebo (Drug)
Escitalopram 20 mg and gaboxadol 5 mg
干预措施: Escitalopram 20 mg (Drug)
Escitalopram placebo and gaboxadol placebo
干预措施: Gaboxadol placebo (Drug)
Escitalopram 20 mg and gaboxadol placebo
干预措施: Gaboxadol placebo (Drug)
Escitalopram 20 mg and gaboxadol placebo
干预措施: Escitalopram 20 mg (Drug)
Escitalopram 20 mg and gaboxadol 5 mg
干预措施: Gaboxadol 5 mg (Drug)
Escitalopram 20 mg and gaboxadol 10 mg
干预措施: Escitalopram 20 mg (Drug)
Escitalopram 20 mg and gaboxadol 10 mg
干预措施: Gaboxadol 10 mg (Drug)
结局指标
主要结局
Montgomery and Åsberg Depression Rating Scale (MADRS)
时间窗: Baseline to 8 weeks
The MADRS is a 10-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). Definitions of severity are provided at 2-point intervals. The total score of the 10 items ranges from 0 to 60.
次要结局
- MADRS(From baseline to Week 8)
- Hospital Anxiety and Depression Scale (HADS)(Mean change from baseline to Week 8)
- Insomnia Severity Index (ISI)(Mean change from baseline to Week 8)
- Sheehan Disability Scale (SDS): Family Subscale(Mean change from baseline to Week 8)
- SDS: Work Subscale(Mean change from baseline to Week 8)
- SDS: Social Subscale(Mean change from baseline to Week 8)
- Clinical Global Impression - Severity of Illness (CGI-S)(Mean change from baseline to Week 8)
- Clinical Global Impression - Global Improvement (CGI-I)(at Week 8)