A Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Dose-exploration Phase II Clinical Trial to Evaluate the Efficacy and Safety of NH102 in the Treatment of Depression
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 243
- 试验地点
- 1
- 主要终点
- 17 items Hamilton Depression Scales (HAM-D17)
研究概览
简要总结
This study is a multicenter, randomized, double-blind, double-dummy, parallel-group, dose-finding Phase II clinical trial with placebo and active comparator duloxetine . It is designed to preliminarily assess the efficacy and safety of NH102 in patients with major depressive disorder and to provide the basis for the design of Phase III clinical trials.
详细描述
This trial consists of three periods: a screening period (up to 2 weeks), a double-blind treatment period (6 weeks), and a tapering-off period/safety follow-up (1 week). The screening period may last up to 14 days and a minimum of 1 day.
Baseline assessments will be conducted prior to randomization to confirm the eligibility of participants. A total of 240 patients with depression will be randomly assigned in a 1:1:1:1:1 ratio to three experimental drug groups (10 mg, 20 mg, and 30 mg), one active control group (duloxetine hydrochloride capsules 60 mg ), or one placebo group. The double-blind treatment period will last for 6 weeks, during which participants will take the assigned medications according to the specified dosing regimen and will be followed up at the end of weeks 1, 2, 4, and 6. After the treatment period, participants will enter a 1-week tapering-off period and will undergo safety follow-up at the end of week 7.
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 and female outpatients aged 18-65 years (inclusive).
- •Diagnosis of Major Depressive Disorder (MDD) according to DSM-5 criteria ( without psychotic features).
- •Hamilton Depression Rating Scale (HAM-D17) total score ≥ 22 at screening and baseline visits, with item 1 (depressed mood) score ≥
- •Clinical Global Impression-Severity (CGI-S) score ≥ 4 at screening and baseline.
- •Negative pregnancy test for women of childbearing potential.
- •Willingness to use effective contraception during the trial and for 3 months after the last dose.
- •Voluntary participation and signed informed consent.
排除标准
- •Duration of the current depressive episode in first-episode patients < 3 months.
- •Treatment-resistant depression (failure of ≥ 2 adequate antidepressant treatments).
- •Other psychiatric disorders (e.g., schizophrenia, bipolar disorder, anxiety disorders).
- •History of severe neurological diseases, epilepsy, or significant head trauma.
- •Unstable or severe cardiovascular, gastrointestinal, or endocrine diseases.
- •History of malignancy within the past 2 years.
- •History of increased intraocular pressure or untreated narrow-angle glaucoma.
- •Abnormal thyroid function not adequately controlled.
- •History of severe drug allergies or hypersensitivity to duloxetine or excipients.
- •Suicide attempt within the past year or significant suicide risk.
- •Substance abuse within the past year or positive at screening drug test.
- •Alcohol abuse (≥ 14 units/week) within the past year.
- •Previous treatment with duloxetine without adequate response.
- •Normative use of antidepressants within 2 weeks prior to screening.
- •Use of CYP2D6 or CYP1A2 potent inhibitors/inducers within 2 weeks prior to screening.
- •Participation in another clinical trial within the past 3 months.
- •Any condition deemed unsuitable by the investigator.
研究组 & 干预措施
NH102 30mg
干预措施: NH102 (Drug)
NH102 10mg
干预措施: NH102 (Drug)
NH102 20mg
干预措施: NH102 (Drug)
Duloxetine Hydrochloride Enteric Capsules
干预措施: Duloxetine Hydrochloride Enteric-coated Capsule (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
17 items Hamilton Depression Scales (HAM-D17)
时间窗: 6 Weeks
Changes from baseline in the 17 items Hamilton Depression Scales (HAM-D17) total score at the end of treatment. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Nine items are scored on a 3 point scale (0=none/absent to 2=most severe) and 8 items are scored on a 5 point scale (0=none/absent to 4=most severe) for a maximum total score of 50. Higher scores indicate a worse outcome.
次要结局
- 17 items Hamilton Depression Scales (HAM-D17)(Week 2 and 4)
- Montgomery- Åsberg Depression Rating Scale(MADRS)(6 Weeks)
- Clinical Global Impression-Improvement (CGI-I)(6 Weeks)
- Clinical Global Impression-Severity (CGI-S)(6 Weeks)
- Hamilton Anxiety Rating Scale (HAM-A)(6 Weeks)
- Dimensional Anhedonia Rating Scale (DARS)(6 Weeks)