A Phase III, A Multicenter, Double-blind, Randomized, Placebo-controlled Study Verify the Efficacy and Safety of Ansofaxine Hydrochloride Extended-release Tablets for Major Depressive Disorder
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 558
- 试验地点
- 1
- 主要终点
- Montgomery- Åsberg Depression Rating Scale(MADRS)
研究概览
简要总结
The purpose of this study is to determine if LY03005 is effective and safe in improve MADRS score, as compared to placebo (no medicine) in participants with Major Depressive Disorder (MDD)
详细描述
The study consisted of two periods: a screening period of 1 week and a double-blind treatment period (8 weeks). After the screening period, 588 enrolled subjects were randomized into one of 3 study groups in the 1:1:1 ratio, 2 LY03005 treatment groups with different dose or 1 placebo group. Subjects were given investigatory drug or placebo according to the protocol, followed up at the end of 1, 2, 4 6, and 8 weeks.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Male or female aged 18 to 65 years subjects from outpatients;
- •Subjects currently meet the Diagnostic and Statistical Manual of Manual Disorders, fifth Edition(DSM-5) criteria for MDD with either single or recurrent episodes (296.2/296.3) without psychotic characteristics;
- •Subjects has a total score of the Montgomery- Åsberg Depression Scale (MADRS) ≥26 points at screening;
- •Subjects has a clinical Global Impression -severity illness (CGI-S) score≥4 points at screening
排除标准
- •Allergic or known to be allergic to venlafaxine and desvenlafaxine;
- •Subjects with MDD who were not responsive to the previous venlafaxine treatment with sufficient amount and duration and to at least two different mechanisms of action antidepressants with adequate amount and duration in the past;
- •There is a clear suicide attempt or behavior and score of the 10th item (suicidal ideation) in MADRS scale is 4 points or greater;
- •Pregnant or lactating women,women who have a planned pregnancy in the near future;
- •Subjects meet the diagnostic criteria for other psychotic disorders(except for MDD) in DSM-5, such as Schizophrenia Spectrum and Other Psychotic Disorders, Bipolar and Related Disorders, Obsessive-Compulsive and related Disorders, post-traumatic stress disorder, separation disorders, anorexia nervosa or bulimia and personality disorder;
- •Subjects who meet the diagnostic criteria for substance or alcohol abuse (excluding nicotine or caffeine) 6 months prior to the screening;
- •MDD secondary to other mental illnesses or physical illnesses;
- •Those with a history of seizures (except for convulsions caused by febrile seizures in children).
研究组 & 干预措施
LY03005 extended-release tablets 80 mg group
orally once a day
干预措施: LY03005 extended-release tablet (Drug)
LY03005 extended-release tablets 160 mg group
orally once a day
干预措施: LY03005 extended-release tablet (Drug)
Placebo group
orally once a day
干预措施: Placebo (Drug)
结局指标
主要结局
Montgomery- Åsberg Depression Rating Scale(MADRS)
时间窗: 8 Weeks
Changes from baseline in the 10-items Montgomery- Åsberg Depression Scales (MADRS) total scores at the end of treatment. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).
次要结局
- 17 items Hamilton Depression Scales (HAM-D17)(8 Weeks)