NCT06958692招募中3 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Dextromethorphan and Bupropion Sustained-Release Tablets in Adult Patients With Major Depressive Disorder
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 388
- 试验地点
- 1
- 主要终点
- Change in MADRS Total Score From Baseline to Week 6
研究概览
简要总结
A multicenter, randomized, double-blind, placebo-controlled, phase 3 trial, aim to evaluate the efficacy and safety of dextromethorphan and bupropion sustained-release tablets in Chinese adult patients with major depressive disorder.
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, Age 18 - 65, inclusive
- •Currently meets DSM-5 diagnosis of MDD without psychotic features, Current major depressive episode of at least 4 weeks in duration at screening
- •Identified as MDD by Mini-international Neuropsychiatric interview (M.I.N.I.)
- •MADRS score ≥25 and CGI-S ≥4 at screening and baseline
- •The results of physical examination and laboratory tests during the screening period meet the test requirements
- •Body Mass Index between 18 and 40 kg/m2, inclusive
- •For male subjects, use of an adequate method of birth control by the subject and by female sexual partners
排除标准
- •The researchers determined that it was refractory depression [defined as in a current depressive episode or a previous depressive episode, After 2 or more antidepressants, a sufficient amount (in the maximum recommendation of the manual), a course of foot therapy (at least even Continued medication for 4-6 weeks) ineffective after treatment]
- •The MADRS score improved by ≥ 25% at baseline compared with the screening period.
- •Hospitalization in a psychiatric hospital during a current depressive episode
- •There is a clinically significant risk of suicide or self-harm and harm to others
- •Screening patients tested positive for substance abuse
- •In the investigator's judgment, there are any clinically significant oncology, hematology, or internal diseases that are not suitable for entry into the study Secretory/metabolic, cardiovascular, respiratory, kidney, liver, gastrointestinal, infectious or nervous system fever Or suffer from an unstable or progressive chronic disease
- •hypertension
- •Hypothyroidism or hyperthyroidism, except for the following cases: receiving stable medication with no change in dose for at least 1 month before screening (serum TSH must be > 0.75×LLN（ Lower Limit of Normal ） and < 1.25×ULN（Upper Limit of Normal ）) 9 Bupropion, dextromethorphan, opioids (such as codeine), or any of the study drugs Allergic to other ingredients
- •Presence of a history of intolerance to bupropion or dextromethorphan
- •People living with HIV, or testing positive for HIV during screening
- •Screening period hepatitis virology test positive
- •Liver enzyme test results during the screening period (total bilirubin, aspartate aminotransferase and/or alanine aminotransferase) > 2.0 × ULN
- •According to the investigator's judgment, other conditions are not suitable for participating in this clinical study
研究组 & 干预措施
Dextromethorphan and Bupropion
Experimental
干预措施: Dextromethorphan and Bupropion Sustained-Release Tablets (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change in MADRS Total Score From Baseline to Week 6
时间窗: 6 weeks
The MADRS is a 10-item scale and items are scored between 0-6 points. For each item, a score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity. A maximum total score is 60 points.
次要结局
- Treatment response rate (the proportion of participants whose total score on the Montgomery-Åsberg Depression Rating Scale (MADRS) has improved by ≥ 50% compared to the baseline at the 6th week after administration)(2 weeks)
- Clinical cure rate (the proportion of participants with a total score of the Montgomery-Åsberg Depression Rating Scale (MADRS) ≤ 10 at the 2nd week after administration)(6 weeks)
- Proportion of participants with a ≥ 30% improvement in total MADRS scores from baseline at week 6 after administration(6 weeks)
- PGI-I score at week 6 after administration(6 weeks)
- CGI-I score (Week 1, Week 2, Week 3, Week 4, Week 6)(1，2，3，4，6 weeks)
- Changes in CGI-S score from baseline to week 6(6 weeks)
- Change in QIDS-SR-16 score from baseline to Week 6(6 weeks)
- Change in SDS score from baseline to Week 6(6 weeks)
- Incidence of adve rse events(Within 7 weeks)
- Incidence of serious adverse events(Within 7 weeks)
- Proportion of participants with significant abnormalities in vital signs(Within 7 weeks)
- Proportion of participants with significant abnormalities in physical examination results(Within 7 weeks)
- Proportion of participants with abnormal electrocardiogram (ECG) parameters(Within 7 weeks)
- Proportion of participants with significant abnormalities in laboratory test results(Within 7 weeks)
- Incidence of suicidal ideation and behavior assessed by C-SSRS（Columbia Suicide Severity Rating Scale），It can comprehensively assess the individual's suicide risk level. The higher the score, the higher the suicide risk.(Within 7 weeks)
- Withdrawal responses as assessed by the PWC-20(7 weeks)
研究者
研究点 (1)
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