A Phase 1, Study to Evaluate the Pharmacokinetics and Safety of Zuranolone in Adolescents (12 to 17 Years of Age) With Major Depressive Disorder
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Plasma Concentrations of Zuranolone
研究概览
简要总结
The primary purpose of this study is to evaluate the pharmacokinetics and safety of Zuranolone in adolescents (ages 12 to 17 years) with MDD.
详细描述
This study was previously posted by Sage Therapeutics. In December 2024, sponsorship of the trial was transferred to Biogen.
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
- 12 Years 至 17 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participant meets Kiddie Schedule for Affective Disorders and Schizophrenia - Present and Lifetime DSM-5 (KSADS-PL DSM-5) criteria for MDD.
- •Participant has a Children's Depression Rating Scale-Revised (CDRS-R) total score greater than or equal to 40 at screening and Day
- •Participant's parent/caregiver is able to attend all scheduled study visits, oversee administration of study drug and complete assessments per the protocol.
- •Participant has a body weight greater than or equal to 20 kg and a body mass index greater than fifth percentile and less than ninety-fifth percentile for age at Screening.
- •Participant is a post-pubertal (has experienced menarche) female (sex assigned at birth), 12 to 17 years of age, inclusive, at the time informed consent/assent is obtained.
排除标准
- •Participant has a history of psychosis, bipolar disorder, autism, seizures, or other restricted comorbid psychiatric or neurological conditions and has treatment-resistant depression.
- •Participant has a known diagnosis of intellectual disability or is unable to communicate with the study investigator or research team.
- •Participant has a history of suicidal behavior or is currently at risk of suicide in the opinion of the investigator.
- •Participant has a recent history of Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM 5) alcohol or drug use disorder or has clinically significant alcohol or drug misuse as judged by the investigator.
- •Note: Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Zuranolone
Participants will be enrolled to receive Zuranolone orally, during the daytime on Day 1 and in the evening on Days 2 to 14. The first 10 enrolled participants will receive 50 mg (participants with a body weight of 54 kg or greater) or 40 mg (participants with a body weight less than 54 kg) once daily. The remaining participants will receive 40 mg once daily with the opportunity to down titrate to 30 mg if 40 mg is not tolerated.
干预措施: Zuranolone (Drug)
结局指标
主要结局
Plasma Concentrations of Zuranolone
时间窗: At multiple timepoints post dose on Days 1, 8 and 15
PK Parameters of Zuranolone will be assessed.
次要结局
- Percentage of Participants With at Least one Treatment Emergent Adverse Event (TEAE)(Up to 42 days)