A Phase 1, Single-Center, Double-Blind, Randomized, Placebo-Controlled Study to Explore the Effect of SP-624 on Brain Network Analytics in Cohorts of Healthy Adult Subjects and Subjects With Major Depressive Disorder
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Brain Network Analytics Profile
研究概览
简要总结
The main goal of this clinical trial is to learn if the active study drug (code name: SP-624) has any effect on the electrical activity of the brain in adult healthy volunteers and in adults with major depression. Another goal of the study is to learn if SP-624 improves memory and learning in adults with major depression. The study will also provide additional information on the safety of SP-624 and how well it is tolerated in adult healthy volunteers and adults with major depression.
Researchers will compare SP-624 to a placebo (a look-alike substance that contains no drug) to see if SP-624 has any effect on study tests.
Study participants will:
Take capsules of study drug (SP-624 or a placebo) once daily for 2 weeks; visit the clinic at Screening, Day 1 (first dose of study drug), and Day 15 (last dose of study drug) for checkups and tests; and have phone call check-ups on Day 7 and about 1 week after the last dose of study drug.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •In generally good health
- •Body mass index (BMI) between 18.0 and 40.0 kg/m2
- •Willing to comply with the requirements of the study
- •For participants with depression: must meet study criteria for moderate to severe major depressive disorder
排除标准
- •Female who is pregnant or breastfeeding.
- •Clinically significant health condition or clinically significant abnormal results on screening health tests
- •For participants with depression: presence of exclusionary study criteria for co-morbid psychiatric conditions or medication history.
研究组 & 干预措施
SP-624
SP-624 oral capsule, once daily for 2 weeks
干预措施: SP-624 (Drug)
Placebo
Placebo oral capsule, once daily for 2 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Brain Network Analytics Profile
时间窗: At the Day 15 Visit, after approximately 2 weeks of daily dosing with the assigned study intervention
Brain activity using an electroencephalography (EEG) system during rest and while evoking specific brain activity response will be recorded, and artificial intelligence (AI) based analytics will be performed on the EEG recordings to provide a brain network analytic (BNA) profile for each study participant. The BNA profile at the Day 15 Visit will be compared to the BNA profile at Day 1 pre-dose to evaluate changes in the profile after 2 weeks of daily dosing with the assigned study intervention.
次要结局
- Spatial Working Memory Test(At the Day 15 Visit, after approximately 2 weeks of daily dosing with the assigned study intervention (Participants with Depression Only))
- Brain Network Analytics Profile(At the Day 1 Visit, completed on study day 1 after the first dose of the assigned study intervention)
- Paired Associates Learning Test(At the Day 15 Visit, after approximately 2 weeks of daily dosing with the assigned study intervention (Participants with Depression Only))
- Digit Symbol Substitution Test(At the Day 15 Visit, after approximately 2 weeks of daily dosing with the assigned study intervention (Participants with Depression Only))
- Treatment Emergent Adverse Events(Through study completion, an average of 22 days)