[Translation] A multicenter, randomized, double-blind, placebo-controlled, dose-finding Phase II clinical study to preliminarily evaluate the efficacy and safety of SIPI6398 tablets in patients with depression
主要目的:
初步评价口服 SIPI6398 片治疗抑郁症的有效性和有效剂量,为后期临床试验研究提供依据。
次要目的:
评价 SIPI6398 片在抑郁症患者用药的安全性和耐受性。
探索目的:
1. 基于群体药代动力学(PopPK)分析方法,评估 SIPI6398 在抑郁症患者中的血浆药代动力学(PK)特征,并探索暴露与疗效和安全性的关系。
2. 探索血清中白细胞介素 1 (IL-1β)、肿瘤坏死因子(TNF-α)和脑源性神经营养因子(BNDF)水平的变化与治疗结果的相关性。
[Translation] Main purpose:
To preliminarily evaluate the efficacy and effective dose of oral SIPI6398 tablets in the treatment of depression, and provide a basis for later clinical trials.
Secondary purpose:
To evaluate the safety and tolerability of SIPI6398 tablets in patients with depression.
Exploratory purpose:
1. Based on the population pharmacokinetic (PopPK) analysis method, evaluate the plasma pharmacokinetic (PK) characteristics of SIPI6398 in patients with depression, and explore the relationship between exposure and efficacy and safety.
2. Explore the correlation between changes in serum interleukin 1 (IL-1β), tumor necrosis factor (TNF-α) and brain-derived neurotrophic factor (BNDF) levels and treatment outcomes.