NCT04479852已完成2 期
A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Efficacy of SP-624 in the Treatment of Adults With 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
- 319
- 试验地点
- 34
- 主要终点
- Change From Baseline to Week 4 in Montgomery Asberg Depression Rating Scale (MADRS) Total Score
研究概览
简要总结
This is a Phase 2 clinical study evaluating the safety and effectiveness of SP-624 as compared to placebo in the treatment of adults 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)
盲法说明
Double-blind
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
- •Willing and able to provide written informed consent to participate in the study
- •Males and females, aged 18 to 65 years
- •In generally good physical health
- •Body mass index (BMI) must be between 18 and 40 kg/m2
- •Females of reproductive potential and males with partners of reproductive potential must agree to remain abstinent or use adequate and reliable contraception throughout the study and for at least 30 days after the last dose of study drug
- •Subjects must meet criteria for moderate to severe Major Depressive Disorder, as confirmed by the Mini International Neuropsychiatric Interview (MINI)
- •Willing and able to comply with the study design schedule and other requirements
排除标准
- •Female who is pregnant, breastfeeding, or less than six months postpartum at Screening
- •History or presence of any clinically significant medical condition, disease, or surgical history that could jeopardize the safety of the subject or validity of the study data, or interfere with the absorption, distribution, metabolism, or excretion of the study drug
- •Failure to discontinue all psychoactive medications or psychoactive supplements including antidepressants and mood stabilizers, within a time period prior to Baseline corresponding to at least five half-lives of the medication in question
- •Presence of a clinically significant abnormality on physical examination or electrocardiogram (ECG), including a corrected QT interval using Fridericia's formula (QTcF) >450 msec for males and >470 msec for females
- •Presence of uncontrolled hypertension, defined as consistent systolic blood pressure (SBP) >160 mmHg or consistent diastolic blood pressure (DBP) >95 mmHg despite present therapy
- •Screening laboratory value(s) outside the laboratory reference range that are considered to be clinically significant by the Investigator (clinical chemistry, hematology, coagulation, and urinalysis)
- •Screening liver function tests (ALT, AST, Alkaline phosphatase) > 2x the upper limit of normal
- •Subjects who, in the opinion of the Investigator, are not suitable candidates for the study
研究组 & 干预措施
SP-624
Experimental
Daily oral capsule, 20 mg/day
干预措施: SP-624 (Drug)
Placebo
Placebo Comparator
Daily oral capsule
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline to Week 4 in Montgomery Asberg Depression Rating Scale (MADRS) Total Score
时间窗: Baseline to Week 4
The Montgomery Asberg Depression rating scale is a 10-item scale used to assess the severity of depression. Individual items are scored on a 7-point scale (0 to 6). The total score is the sum of individual items, ranging from 0 to 60; where a higher score indicates more depression.
次要结局
- Change From Baseline to Week 4 in Clinical Global Impression - Severity (CGI-S) Total Score(Baseline to Week 4)
- Change From Baseline to Week 4 in the 17-item Hamilton Depression Rating Scale (HAM D-17) Total Score(Baseline to Week 4)
- Change From Baseline to Week 4 in the Sheehan Disability Scale (SDS)(Baseline to Week 4)
- Change From Baseline to Week 4 in the Quick Inventory of Depressive Symptomology - Self Report (QIDS-SR)(Baseline to Week 4)
- Change From Baseline to Week 4 in the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)(Baseline to Week 4)
研究者
研究点 (34)
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