NCT07485595尚未招募2 期
A Phase 2/Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Effectiveness and Safety of JS1-1-01 Tablet in Patients With Moderate to Severe Depression
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- The change in MADRS total score from baseline
研究概览
简要总结
The purpose of this study is to evaluate the Effectiveness and Safety of JS1-1-01 Tablet in Patients With Moderate to Severe Depression
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
- •Age range from 18 to 65 years old (including boundary values), both male and female;
- •Single or recurrent episodes that meet the diagnostic criteria for depression in DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th edition);For patients with a single episode, the duration of this depressive episode must be ≥90 days.
- •Screening and baseline periods, the total score of the Montgomery Asperger Depression Rating Scale (MADRS) was ≥ 26 points;
- •Screening and baseline periods, with a Clinical Global Impression Scale Disease Severity (CGI-S) score of ≥ 4 points;
- •Voluntary participation in clinical trials, able to sign informed consent forms, and able to understand and comply with research procedures.
排除标准
- •Individuals with a history of severe drug allergies or allergies to Piper Piper (pepper plant) ;
- •Those who have used at least two antidepressants in sufficient dosage and duration (treated according to the maximum dosage in the instructions for at least 4 weeks) in a single or current episode in the past but still have no effect;
- •The patients of depression secondary to other mental or physical illnesses;
- •Patients of depression with accompanying psychiatric symptoms;
- •Significant suicidal attempt or behavior within the past year, with a score of ≥ 3 on the 10th item (suicidal ideation) of the MADRS scale;
- •Individuals with a history of epileptic seizures (excluding convulsions caused by febrile seizures in children);
- •Individuals who have received depression related systemic physical therapy within 3 months prior to their first administration: modified electroconvulsive therapy (MECT), transcranial magnetic stimulation (TMS), vagus nerve stimulation (VNS), deep brain stimulation (DBS), phototherapy, or systemic psychotherapy;
- •Systematically receiving antidepressant treatment within the first 2 weeks of randomization, or discontinuing antidepressant medication for less than 5 half-lives before randomization;
- •Those with severe unstable cardiovascular and cerebrovascular diseases, respiratory system diseases, gastrointestinal diseases, liver diseases, kidney diseases, blood diseases, endocrine diseases, or a history of such physical diseases;
- •Accompanied by a history of malignant tumors (excluding cured skin basal cell carcinoma and cervical carcinoma in situ);
- •Screening or baseline electrocardiogram abnormalities that have clinical significance and are deemed unsuitable for inclusion by investigators, such as male QTcF ≥ 450 ms, female QTcF ≥ 470 ms, or having a history of long QT syndrome;
- •During the baseline period, those with a reduction rate of ≥ 25% in the MADRS scale score compared to the screening period;
- •A history of symptomatic orthostatic hypotension (i.e. orthostatic syncope) with clinical significance;
- •During the screening or baseline period, TBIL is above 2 times the upper limit of normal value, and ALT or AST is above 2 times the upper limit of normal value; Cr is higher than 1.2 times the upper limit of normal value;
- •Thyroid dysfunction (TSH above 1.2 times the upper limit of normal value or below 0.8 times the lower limit of normal value) or the presence of hyperthyroidism or hypothyroidism determined by the investigators; Individuals with a history of elevated intraocular pressure or narrow angle glaucoma;
- •Screening period, drug abuse screening positive individuals;
- •A history of alcohol dependence within one year prior to screening(Drinking alcohol for more than 5 years, equivalent ethanol intake, daily alcohol consumption: men >40 g/d, women >20 g/d; drinking ≤5 years, equivalent ethanol intake, history of heavy drinking (>80 g/d) within 2 weeks);
- •Pregnant and lactating women, male or female subjects who have a family planning or are unable to take effective contraceptive measures within 30 days after signing the informed consent form and ending the trial;
- •Screening for individuals who have participated in clinical trials and taken investigational drugs within the first 30 days;
- •The investigators believe that the subjects have poor compliance or there are other clinical, social, or family factors that are not suitable for enrollment.
结局指标
主要结局
The change in MADRS total score from baseline
时间窗: 8 weeks
There are a total of 10 projects in Montgomery-Asberg Depression Rating Scale（MADRS）, each with a 7-point scoring system ranging from 0 to 6 points. The higher the score, the more severe the degree of depression.
次要结局
- The change in HAMD-17 total score from baseline(8 weeks)
- The effective rate of MADRS(8 weeks)
- The effective rate of HAMD-17(8 weeks)
- The response rate of MADRS(8 weeks)
- The response rate of HAMD-17(8 weeks)
- The change in MADRS Single item score from baseline(8 weeks)
- The change in HAMD-17 factor score from baseline(8 weeks)
- The change in CGI-S total score from baseline(8 weeks)
- Proportion of participants with a CGI-S score of 1/2(8 weeks)
- Proportion of CGI-I Scores on the Clinical Global Impression Scale(8 weeks)
- The change in HAMA total score from baseline(8 weeks)
研究者
研究点 (1)
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