A 6-Week, Multicenter, Open-Label, Monotherapy, Extension Study of SPT-300 in Adults With Major Depressive Disorder, With or Without Anxious Distress
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 入组人数
- 360
- 试验地点
- 40
- 主要终点
- Safety and tolerability assessments based on Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and validated clinical scales and procedures
研究概览
简要总结
This is an open-label, monotherapy, extension study to evaluate the safety and tolerability of SPT-300 (GlyphAllo) in adults with major depressive disorder (MDD), with or without anxious distress.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 66 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant who completed treatment in Study SPT-300-2024-203 (i.e., participant who competed Visit 8 [Day 42] of Study SPT-300-2024-203 [BUOY-1 Study]).
- •Women of childbearing potential (WOCP) must not plan to become pregnant during the course of the study or be currently breastfeeding. WOCP must agree to use a highly effective form of contraception during participation in the study and for 30 days after receiving the last dose of study treatment.
- •Participant is willing and able to refrain from the use of drugs of abuse.
排除标准
- •Participants who, in the opinion of the Investigator, medical monitor, or Sponsor, should not participate in the study.
- •Participants who, in the judgment of the Investigator, were noncompliant with trial procedures or with study treatment administration during the double-blind study (BUOY-1 Study).
- •Female participants with a positive urine pregnancy test result. Female participants may be enrolled without a negative urine test if they are surgically sterile or at least 2 years post-menopause.
研究组 & 干预措施
SPT-300
Participants will receive SPT-300 capsules once daily for 42 days
干预措施: SPT-300 (Drug)
结局指标
主要结局
Safety and tolerability assessments based on Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and validated clinical scales and procedures
时间窗: Up to Day 49
Adverse events (AEs) are monitored from Day 1 to 49. A TEAE is as any AE with an onset after first dose of study treatment up to Day 49. Clinically significant abnormalities in clinical laboratory evaluations, ECGs, vital signs, physical examinations and Columbia Suicide Severity Rating Scale (C-SSRS) will be reported as TEAEs.
次要结局
未报告次要终点