NCT06254612已完成2 期
A Multi-center, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety 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
- 497
- 试验地点
- 95
- 主要终点
- Change from Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) total score.
研究概览
简要总结
This is a Phase 2B clinical study evaluating the effectiveness and safety 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)
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
- •Males and females, aged 18 to 65 years, inclusive.
- •Meet DSM-5 criteria for moderate to severe MDD, as confirmed by the Mini International Neuropsychiatric Interview (MINI).
- •In generally good physical health, in the opinion of the Investigator.
- •Body mass index (BMI) must be ≥ 18 and ≤ 45 kg/m
排除标准
- •Female who is pregnant, breastfeeding, or less than 6 months postpartum at screen.
- •A history of or current DSM-5 diagnosis of MDD with psychotic features, any schizophrenia spectrum and other psychotic disorders, bipolar disorder, or personality disorder.
- •Presence or history of any known clinically significant cardiovascular disorders including, but not limited to: coronary artery disease, heart failure, valvular heart disease, cardiomyopathies, myocardial infarction, chamber enlargement or hypertrophy, or orthostatic hypotension.
- •Presence of uncontrolled hypertension, defined as consistent sitting systolic blood pressure (SBP) >160 mmHg or consistent sitting 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, thyroid function, and urinalysis).
研究组 & 干预措施
SP-624
Experimental
Participants to receive two 10 mg capsules of SP-624 once daily for a total daily dose of 20 mg
干预措施: SP-624 (Drug)
Placebo
Placebo Comparator
Participant to receive 2 matching placebo capsules once daily
干预措施: Placebo (Drug)
结局指标
主要结局
Change from Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) total score.
时间窗: Baseline to Week 4
The MADRS is a 10-item depression rating scale used to assess the severity of depression. Individual items are scored on a 7-point scale (0 to 6). The toal 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 in the Clinical Global Impression - Severity (CGI-S) score.(Baseline to Weeks 1-4 and 1- and 2- Week Follow-up)
- Incidence rates of treatment emergent adverse events (TEAEs), serious adverse events (SAEs), and TEAEs leading to withdrawal from study.(Baseline to Weeks 1-4 and 1- and 2- Week Follow up)
- Change from Baseline in Quick Inventory of Depressive Symptomology-Self-Report (QIDS-SR) total score.(Baseline to Weeks 1-4 and 1- and 2- Week Follow-up)
- Change from Baseline in Symbol Digit Modalities Test (SDMT) score.(Baseline to Weeks 2 and 4)
- Change from Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) total score.(Baseline to Weeks 1-3 and 1- and 2- Week Follow-up)
- Change from Baseline in 17-item-Hamilton Depression Rating Scale (HAM-D-17) total score.(Baseline to Weeks 2 and 4)
- Change from Baseline in Sheehan Disability Scale (SDS) total score.(Baseline to Weeks 2 and 4)
研究者
研究点 (95)
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