A Multicenter, Randomized, Double-blind, Placebo Controlled Study to Explore the Effective Doses and to Assess the Safety and Efficacy of Hypidone Hydrochloride Tablets in Patients With Major Depressive Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 19
- 主要终点
- Montgomery-Asberg Depression Rating Scale (MADRS)
研究概览
简要总结
The objective of this study is to evaluate the safety and efficacy of Hypidone Hydrochloride tablets in treatment of patients with major depressive disorder (MDD) by evaluating the change of MADRS total scores from baseline to week 6.
详细描述
A total of 240 major depressive disorder (MDD) subjects between the ages of 18-65 who have current major depressive disorder diagnosed by DSM-5 will be recruited, Eligible patients will be randomized with a 1:1:1:1 ratio into the 4 treatment arms to receive either Hypidone Hydrochloride tablets or placebo, and will be accepted into the protocol after review and providing voluntary written informed consent forms and completion of a comprehensive medical and psychiatric history, physical examination, mental status examination, and routine laboratory assessment.
The subjects will accept the drug treatment twice daily orally for 6 weeks. During the treatment follow up will occur at 8±1 days after treatment, 15±1 days after treatment, 29±2 days after treatment , 43±2 days after treatment to evaluate the safety and efficacy of the drug.
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
- •Outpatient or Inpatient, 18-65 years old, male or female
- •Current major depressive disorder diagnosed by DSM-5, single episode(296.21, 296.22, 296.23), or recurrent episode(296.31, 296.32, 296.33)
- •Montgomery-Åsberg Depression Rating Scale (MADRS) total scores in both Screening and Baseline ≥ 26
- •The first item of MADRS in both Screening and Baseline ≥ 3
- •CGI-S in both Screening and Baseline ≥ 4
- •Able to provide written informed consent forms
排除标准
- •Subjects accord with other mental disorders diagnosed by DSM-5
- •Subjects who attempted to suicide, or who presently have a high risk of suicide, or with the tenth item (Suicidal ideation) of C-SSRS ≥ 3
- •Baseline total scores compared with the screening period, the reduction rate of MADRS ≥ 25%
- •Subjects with serious or uncontrolled cardiovascular disease, liver disease, kidney disease, blood disease, endocrine disease, respiratory disease
- •Subjects with clinically significant ECG abnormal (Male QTcF ≥ 450 msec, Female QTcF ≥ 470 msec)
- •Treatment with a MAOI within the 2 weeks prior to the first dose of trial medication
- •Practicing 2 different treatment methods of antidepressants as recommended dose of full course (≥6 weeks)
- •Subjects who have had a Vagus Nerve Stimulation (VNS) device implanted, or who have received Modified Electric Convulsive Therapy (MECT) or Transcranial Magnetic Stimulation (TMS) within 3 months of Screening, or who received light treatment, laser treatment, acupuncture and other Chinese medicine treatment, biofeedback treatment within 2 weeks of Screening
- •Subjects with a history of true allergic response to more than 1 class of medications
- •Subjects who participated in a clinical trial within the last 30 days
研究组 & 干预措施
10 mg of Hypidone Hydrochloride tablets
Hypidone Hydrochloride tablets 10mg/day Study,5mg tablet is to be given orally, twice daily, for 6 weeks
干预措施: Hypidone Hydrochloride tablets (Drug)
20 mg of Hypidone Hydrochloride tablets
Hypidone Hydrochloride tablets 20mg/day Study,10mg tablet is to be given orally, twice daily, for 6 weeks
干预措施: Hypidone Hydrochloride tablets (Drug)
40 mg of Hypidone Hydrochloride tablets
Hypidone Hydrochloride tablets 40mg/day Study,20mg tablet is to be given orally, twice daily, for 6 weeks
干预措施: Hypidone Hydrochloride tablets (Drug)
comparator
Placebo tablets is to be given orally, twice daily, for 6 weeks
干预措施: Placebo (Other)
结局指标
主要结局
Montgomery-Asberg Depression Rating Scale (MADRS)
时间窗: Baseline,43 days after treatment
Change from baseline in MADRS scores，the \*total\* score ranges\[0,60\],higher values represent a worse outcome
次要结局
- Hamilton Anxiety Rating Scale (HAM-A)(Baseline,43 days after treatment)
- Clinical Global Impression of Severity Scale(CGI-S)(Screening,Baseline, 8 day after treatment,15 day after treatment,29 day after treatment,43 day after treatment)
- Clinical Global Impression of Improvement Scale(CGI-I)(8 day after treatment,15 day after treatment,29 day after treatment,43 day after treatment)
- Hamilton Depression Scale 17 items(HAMD17)(Baseline,43 days after treatment)
- Change in Digit Symbol Substitution Test (DSST)(Baseline, 43 days after treatment)
- Change in Trail Making Test Parts A&B (TMT)(Baseline, 43 days after treatment)