NCT06419608已完成2 期
A Phase 2 Multicenter, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of BHV-7000 Monotherapy in Major Depressive Disorder
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 336
- 试验地点
- 102
- 主要终点
- Change in Montgomery- Åsberg Depression Rating Scale (MADRS) total score from baseline to week 6
研究概览
简要总结
The purpose of this study is to determine the efficacy and safety of BHV-7000 in participants with Major Depressive Disorder (MDD)
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects experiencing a moderate to severe episode of depression.
- •Subjects experiencing a current episode of depression for at least 2 months.
- •Subjects must be willing to discontinue all psychotropic medications (other medications to treat depression) before entering the study.
- •Male and Female participants 18 to 75 years of age at the time of consent.
- •Body Mass Index (BMI) must be ≥ 18 kg/m2 and ≤ 35 kg/m
排除标准
- •Subjects taking more than 2 medications (other than benzodiazepines and medications targeting insomnia) to treat depression at the screening visit.
- •Subjects with a history of bipolar disorder, schizophrenia, or other neuropsychiatric conditions that may interfere with the conduct of the study.
- •Subjects with a history of medical conditions that may interfere with the conduct of the study.
- •Females who are pregnant, breastfeeding or planning to become pregnant.
研究组 & 干预措施
BHV-7000
Experimental
干预措施: BHV-7000 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Montgomery- Åsberg Depression Rating Scale (MADRS) total score from baseline to week 6
时间窗: Baseline to Week 6
The MADRS is a clinician- rated scale to assess depressive symptoms which consists of 10 items. Each item is scored on 7-point scale (0 \[absence of symptoms\] to 6 \[severe\]). A higher score represents a higher severity of the level of depression (total scores range from 0 to 60).
次要结局
- Change in Clinical Global Clinical Impression - Severity Scale (CGI-S) total score(Baseline to Week 6)
- Change in Snaith-Hamilton Pleasure Scale (SHAPS) total score from baseline to week 6(Baseline to Week 6)
- Change in Montgomery- Åsberg Depression Rating Scale (MADRS) total score from baseline to week 1(Baseline to Week 1)
- Change in Snaith-Hamilton Pleasure Scale (SHAPS) total score from baseline to week 1(Baseline to Week 1)
- Change in Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q- LES-Q-SF) total score(Baseline to Week 6)
- Number of Participants With Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and AEs judged to be related to study medication(Screening through Week 8)
- Number of Participants With Clinically Significant Laboratory Abnormalities(Screening through Week 8)
- Number of Participants With Vital Sign Abnormalities(Screening through Week 8)
- Number of Participants With Electrocardiogram (ECG) Abnormalities specific to QTc elevation(Screening through Week 8)
研究者
研究点 (102)
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