NCT01128452终止2 期
A 4-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Investigate the Safety and Efficacy of EVT 101 as Monotherapy in Patients With Treatment-Resistant Major Depression
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 14
- 主要终点
- Safety and Tolerability Profile of EVT 101
研究概览
简要总结
This study is a 4-week, randomized, double-blind, parallel-group, placebo-controlled monotherapy study in patients with treatment-resistant major depression. After confirmation of treatment-resistance in a prospective treatment period with citalopram, each patient will be treated with either EVT 101 once daily or placebo for 28 consecutive days.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Major Depressive Disorder
- •Current episode of major depression that has not benefited from at least 1 but no more than 3 adequate treatment regimens
- •Has as score of >/= 18 on the Ham-D-17
排除标准
- •Pregnant or breast-feeding women
- •Evidence of age-related cognitive decline or mild dementia
- •At imminent risk of committing suicide
- •Has with the exception of major depression, a serious medical or neurological illness, including seizure disorder, stroke, dementia, or Parkinson disease
- •Has an established diagnosis of bipolar disorder, hypomania, schizoaffective disorder, major depression with psychotic features or schizophrenia
- •Has had a substance or alcohol abuse or dependence disorder (except nicotine and caffeine) in the 1 year before screening
研究组 & 干预措施
EVT 101
Experimental
EVT 101
干预措施: EVT 101 (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and Tolerability Profile of EVT 101
时间窗: 28 days of EVT 101-Treatment
AE monitoring, clinical laboratory assessments, vital sign measurements, body weight, 12-lead ECG, physical exmaninations, ophthalmological examinations and questionnaires
次要结局
- Percentage of patients who respond to treatment with study drug(4 weeks)
- Efficacy of EVT 101 in depression measured using the MADRS score(28 days)
- Percentage of patients who experience remission(4 weeks)
研究者
研究点 (14)
Loading locations...
相似试验
已完成
4 期
The Effects of Mometasone Furoate Nasal Spray in Subjects With Sleep-disordered Breathing (SDB) Associated With Perennial Allergic Rhinitis (Study P04726)Obstructive Sleep ApneaSleep DisorderPerennial Allergic RhinitisNCT00359216Organon and Co30
已完成
2 期
AMZ001 for the Treatment of Knee Osteoarthritis SymptomsOsteoarthritis, KneeNCT03691844Amzell444
已完成
2 期
A Study of Oxidative Pathways in MS FatigueFatigueProgressive Multiple SclerosisNCT02804594University of California, San Francisco15
已完成
4 期
The Effect of Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets Compared to Placebo in Subjects Suffering From the Common Cold or Influenza.Common ColdNCT02246166GlaxoSmithKline53
已完成
2 期
Fasitibant Intra-articular Injection in Patients With Symptomatic Osteoarthritis of the KneeKnee OsteoarthritisNCT02205814Menarini Group436