A Double-Blind, Placebo-Controlled, Randomized Add-On Study of MSI-195 (Methylation Sciences Inc. S-Adenosyl-L-Methionine, SAMe) For Patients With Major Depressive Disorder(MDD) Who Have Had An Inadequate Response to Current Antidepressant Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 376
- 试验地点
- 2
- 主要终点
- Change in the total Hamilton Depression Rating Scale (HAM-D17) between randomization and end of study.
研究概览
简要总结
The purpose of this study is to determine the efficacy and safety of 800 mg MSI-195 in reducing symptoms of depression in Major Depressive Disorder (MDD)patients with inadequate response to current antidepressant therapy.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets the Diagnostic and Statistical Manual of Mental Disorder, 4th Edition, Text Revision (DSM-IV-TR) criteria for Major Depressive Disorder (MDD)
- •A total score of 16 or higher on the Hamilton Rating Scale for Depression- 17 item version (HAM-D17) at the Screening and Baseline Visits, with a score of ≥2 on mood item
- •Have experienced 1-4 prior Major Depressive Episodes. Patients with more than 5 lifetime episodes (including current episode) will require discussion with the medical monitor prior to inclusion.
- •Failed 1-3 treatment regimens in the current depressive episode
- •Received an adequate dose and duration of Antidepressant Therapy (ADT) (on ADT for at least 6 weeks with a stable dose for at least 3 weeks)
排除标准
- •Failed 4 or more adequate treatment regimens in current episode of depression
- •patient may have a significant risk for suicidal behavior during the course of their participation in the study
- •Intolerance to SAMe; Prior use of MSI-195
- •History of any of the following psychiatric disorders: eating disorder within 6 months; obsessive compulsive disorder, psychotic disorder, bipolar disorder, mental retardation, dementia or other forms of cognitive impairment at any time or alcohol or substance abuse
- •>3X upper limit of normal (ULN) Alkaline Phosphatase, aspartate aminotransferase (AST), alanine aminotransferase (ALT); >1.5X ULN total bilirubin
- •Pregnant or lactating women
- •Any history of seizures, excluding febrile seizures
- •Known positivity for human immunodeficiency virus
研究组 & 干预措施
MSI-195
Patients randomized to the MSI-195 arm will receive treatment with 2 tablets (800 mg) of MSI-195 plus on-going antidepressant therapy (ADT).
MSI-195 800 mg (two tablets) taken orally once a day in the morning on an empty stomach with water (food should be avoided for at least 1 hr after taking the study drug)
干预措施: MSI-195 (Drug)
Placebo
Patients randomized to the placebo arm will receive 2 tablets placebo plus on-going antidepressant therapy (ADT).
Placebo (two tablets) taken orally once a day in the morning on an empty stomach with water (food should be avoided for at least 1 hr after taking the study drug).
干预措施: Placebo (Drug)
结局指标
主要结局
Change in the total Hamilton Depression Rating Scale (HAM-D17) between randomization and end of study.
时间窗: assessed from baseline to week 8 (end of study)
Based on historical data, the standard deviation is assumed to range between 9 and 12. With a standard effect size of 0.367 a total of at least 120 evaluable patients per group are needed to provide 80% power with a two-sided 5% significance level. HAM-D17 will be derived from the Combined HAM-D28-MADRS Instrument.
次要结局
- change in the total score of the Montgomery-Asberg Depression Rating Scale (MADRS)(collected at baseline, weeks 2, 4, 6, 7 and 8 (end of study))
- change in total score of the Clinical Global Impression Improvement Scale (CGI-S)(assessed from baseline, weeks 2, 4, 7 and 8 (end of study))
- change from randomization to each study visit in the total score of the Inventory of Depressive Symptomatology-Self Rated (IDS-SR30)(assessed on baseline visit, Week 2, 4, 6, and 8 (end of study).)
- Adverse events(collected at baseline, weeks 1, 2, 3, 4, 6, 8 and 9 (follow up))
- Columbia Suicide Severity Rating Scale (C-SSRS)(assessed at baseline, weeks 2, 4, 6 and 8 (end of study))