An Open-label Study Evaluating the Pharmacokinetics and Tolerability of [Vortioxetine] Lu AA21004 in Connection With Multiple Oral Dosing of [Vortioxetine] Lu AA21004 in Child and Adolescent Patients With a DSM-IV Diagnosis of Depressive or Anxiety Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 7
- 主要终点
- Cmax of Vortioxetine
研究概览
简要总结
The objective of the study is to evaluate the pharmacokinetics of vortioxetine and its metabolites in connection with multiple oral dosing in child and adolescent patients with a DSM-IV-TR diagnosis of Depressive or Anxiety Disorder
详细描述
The study will be conducted in the US and in Europe and will include paediatric patients diagnosed with depressive or anxiety disorders of two age populations; children aged 7-11 years and adolescents of the age 12-17 years. It is an open study to allow pharmacokinetic (PK) sampling of all patients and four dose levels will be tested. Following lower initial doses for 2 to 6 days, the patients will be treated once daily at the assigned dose levels for 14 days, and it is expected that patients may benefit from treatment during this period. As the treatment duration is not sufficient according to treatment guidelines, if judged or indicated by the investigator, the patients are offered to continue in an extension treatment of up to six months to allow possibility for therapeutic satisfaction.
Preferably, the cohorts will be dosed in the following order: AC1, AC2, CC1, AC3, CC2, AC4, CC3, and CC4. An external data safety monitoring board (DSMB) will be established to evaluate safety, tolerability and preliminary PK data from the dosed cohort(s) prior to any dosing of subsequent cohort (s). The dose regimen may be adjusted based on the recommendation of the DSMB. Adolescents will be exposed to a certain dose of vortioxetine before children receive the same dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a DSM-IV-TR diagnosis of Depressive or Anxiety Disorder.
- •The patient and parent(s)/legal representative(s) are able to comprehend and satisfactorily comply with the protocol requirements.
- •Treatment with antidepressant therapy is warranted, as judged by the investigator.
排除标准
- •The patient is pregnant or breast-feeding.
- •The patient presents or has a history of an Axis I (DSM-IV-TR) diagnosis of Bipolar Disorder, Post Traumatic Stress Disorder (PTSD), Autism, Pervasive Developmental Disorder (PDD), Obsessive Compulsive Disorder (OCD) or Schizophrenia or Schizoaffective Disorder.
- •The patient has not maintained a stable dose of a methylphenidate or amphetamine for their treatment of attention-deficit/hyperactivity disorder (ADHD) for a minimum of 4 weeks prior to the study treatment.
- •The patient has a known mental retardation, or clinical evidence or known social or school history indicative of mental retardation.
- •The patient is at significant risk of committing suicide based on history (for example previous suicide attempt) or according to the investigator's experience, or based on active suicidal ideation, intent or plan, item 4 or 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS).
- •The subject has any concurrent illness that may affect the particular target or absorption, distribution, and elimination of the investigational medicinal product (IMP).
- •The patient meets DSM-IV-TR criteria for any psychoactive substance or alcohol use disorder.
- •Other inclusion and exclusion criteria may apply.
研究组 & 干预措施
Cohort AC1, 6 adolescents
干预措施: Vortioxetine (Drug)
Cohort CC1, 6 children
干预措施: Vortioxetine (Drug)
Cohort CC2, 6 children
干预措施: Vortioxetine (Drug)
Cohort CC3, 6 children
干预措施: Vortioxetine (Drug)
Cohort CC4, 6 children
干预措施: Vortioxetine (Drug)
Cohort AC2, 6 adolescents
干预措施: Vortioxetine (Drug)
Cohort AC3, 6 adolescents
干预措施: Vortioxetine (Drug)
Cohort AC4, 6 adolescents
干预措施: Vortioxetine (Drug)
结局指标
主要结局
Cmax of Vortioxetine
时间窗: Pre-dose and 1, 3, 5, 8, 12 and 24 hours post-dose on Day 14, 16, 18, or 20, depending on assigned dose level
Maximum plasma concentration of vortioxetine
AUC(0-24h) of Vortioxetine
时间窗: Pre-dose and 1, 3, 5, 8, 12 and 24 hours post-dose on Day 14, 16, 18 or 20, depending on assigned dose level
Area under the vortioxetine plasma concentration-time curve from 0 to 24 hours
Cmax of Lu AA34443
时间窗: Pre-dose and 1, 3, 5, 8, 12 and 24 hours post-dose on Day 14, 16, 18, or 20, depending on assigned dose level
Maximum plasma concentration of the major, inactive metabolite Lu AA34443
Oral Clearance (CL/F) of Vortioxetine
时间窗: Pre-dose and 1, 3, 5, 8, 12 and 24 hours post-dose on Day 14, 16, 18 or 20, depending on assigned dose level
Oral clearance expressed as a function of bioavailability
t½ of Vortioxetine
时间窗: Pre-dose and 1, 3, 5, 8, 12 and 24 hours post-dose on Day 14, 16, 18 or 20, depending on assigned dose level
Half-life of vortioxetine in plasma
AUC(0-24h) of Lu AA34443
时间窗: Pre-dose and 1, 3, 5, 8, 12 and 24 hours post-dose on Day 14, 16, 18 or 20, depending on assigned dose level
Area under the plasma concentration-time curve from 0 to 24 hours for the major, inactive metabolite Lu AA34443
t½ of Lu AA34443
时间窗: Pre-dose and 1, 3, 5, 8, 12 and 24 hours post-dose on Day 14, 16, 18 or 20, depending on assigned dose level
Half-life of the major, inactive metabolite Lu AA34443 in plasma
次要结局
未报告次要终点