NCT07096791已完成2 期
A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Pharmacokinetics of KH607 in the Treatment of Adult Female Participants With Postpartum Depressive Disorder
Chengdu Kanghong Pharmaceutical Group Co., Ltd.1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2025年9月2日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Change From Baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D17) Total Score at Day 15
研究概览
简要总结
This is a study evaluating the efficacy, and safety of KH607 in 72 participants diagnosed with Postpartum Depressive Disorder.
详细描述
The study is a randomized, double-blind, parallel-group, placebo-controlled design. Eligible participants were randomized to KH607 group or placebo group for 14 days.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age: 18 to 45 years old (inclusive), female.
- •Participant had a major depressive episode that began no earlier than the third trimester and no later than the first 4 weeks following delivery, as diagnosed by Structured Clinical Interview for Diagnostic and Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) .
- •Participant was <=12 months postpartum.
- •Participant has a Hamilton Rating Scale for Depression (HAM-D) total score ≥26 at screening and Day 1 (prior to dosing).
- •Participant either must have ceased lactating at screening or, if still lactating or actively breastfeeding at screening, must agree to temporarily cease giving breast milk to her infant(s).
- •Fully understand the procedures and sigh the informed consent.
排除标准
- •Participant is currently at significant risk of suicide, or has attempted suicide associated with the current episode of MDD.
- •Participant has a history of treatment-resistant depression, defined as persistent depressive symptoms despite treatment with adequate doses of antidepressants from two different classes for an adequate amount of time.
- •Participant has active psychosis.
- •Participant had used modified electroconvulsive therapy (MECT), transcranial magnetic stimulation (TMS), vagus nerve stimulation (VNS), deep brain stimulation (DBS), light therapy, etc. within 1 month prior to Day
- •Subject has a history of sleep apnea.
- •Participant has a medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder (such as olanzapine, risperidone, quetiapine, aripiprazole, eptifamol, ziprasidone, caliparazine, sodium valproate, lithium carbonate, etc.) within the current major depressive episode.
- •Participant has a clinically significant abnormal 12-lead ECG at the screening or baseline visits. NOTE: mean QT interval calculated using the Fridericia method (QTcF) of >450 msec in males or >470 msec in females will be the basis for exclusion from the study.
研究组 & 干预措施
Placebo
Placebo Comparator
Eligible participants receive matching placebo tablets once daily for 14 days.
干预措施: placebo (Drug)
KH607
Experimental
Participants receive KH607, 30 milligrams (mg), oral tablets, once daily for 14 days, as tolerated.
干预措施: KH607 tablet (Drug)
结局指标
主要结局
Change From Baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D17) Total Score at Day 15
时间窗: Baseline, Day15
The HAM-D total score comprised a sum of 17 individual item scores.The total score could range from 0 to 52. Higher scores indicated a greater degree of depression.
次要结局
- Change From Baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D17) Total Score at all other time points(Day3,8,21 and 28)
- Percentage of Participants With HAM-D Remission(Day 3,8,15,21 and 28)
- Change From Baseline in the Montgomery and Åsberg Depression Rating Scale (MADRS) Total Score at Day 15 and All Other Time Points(Day 3,8,15,21 and 28)
- Percentage of Participants With Clinical Global Impression - Severity (CGI-S) Response(Day 3,8,15,21 and 28)
- Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response(Day 3,8,15,21 and 28)
- Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score at All Time Points(Day 3,8,15,21 and 28)
- Percentage of Participants With HAM-D Response(Day 3,8,15,21 and 28)
- Change From Baseline in Self-Reported Measures of Depressive Symptoms, as Assessed by the Edinburgh Postnatal Depression Scale (EPDS) Total Score(Day 3,8,15,21 and 28)
研究者
研究点 (1)
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