EUCTR2021-000567-77-IT进行中（未招募）1 期
A Short-term Exploratory Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Seltorexant as Adjunctive Therapy to Antidepressants in Adolescents with Major Depressive Disorder Who Have an Inadequate Response to an SSRI and Psychotherapy - A Short-term Exploratory Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Seltorexant
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 52
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Each potential participant must satisfy all of the following criteria to be enrolled in the study:
- •1. Male or female, aged 12 to <18 years at screening.
- •Type of Participant and Disease Characteristic
- •2. Must meet DSM-5 diagnosis of MDD without psychotic features.
- •3. Has inadequate response to at least 1, but no more than 2 antidepressant treatments during the current major depressive episode including their current antidepressant (SSRI).
- •4. Has had at least 6 sessions of psychotherapy in this episode prior to randomization.
- •5. Must have Children's Depression Rating Scale-Revised (CDRS-R) total score >=48 at the beginning of screening with no more than a 25% improvement during screening.
- •6. Must be otherwise healthy on the basis of physical examination, medical history, vital signs, 12-lead ECG, and clinical laboratory tests performed at screening.
- •7. Participants weighing between 5th and 95th percentile for age and sex with baseline weight is >=30 kg.
- •For the full list of inclusion criteria, please refer to the protocol.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Any potential participant who meets any of the following criteria will be excluded from participating in the study:
- •Medical Conditions
- •- Has current active DSM-5 diagnosis of obsessive-compulsive disorder, post-traumatic stress disorder, anorexia nervosa or bulimia nervosa. A prior history of one or more of these disorders is allowed as long as the disorder(s) have been in remission for at least 6 months. Stable Attention deficit/hyperactive disorder (ADHD/ADD) is allowed. Comorbid anxiety disorders are allowed.
- •- Has history or current diagnosis of psychotic disorder, bipolar disorder, conduct disorder, intellectual disability, autism spectrum disorder, borderline personality disorder, somatoform disorders, or fibromyalgia.
- •- Has a significant primary sleep disorder confirmed by PSG assessment at screening for participants in subgroup, but participants with insomnia or hypersomnia disorders are allowed.
- •- At significant risk of committing suicide based on history 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) within the past 3 months or a history of suicidal behavior within the last 6 months.
- •- Has a history of moderate to severe substance use disorder including alcohol use disorder according to DSM-5 criteria within 6 months before screening or positive test result(s) for alcohol and/or drugs of abuse.
- •- Has known allergies, hypersensitivity, or intolerance to seltorexant or its excipients.
- •For the full list of exclusion criteria, please refer to the protocol.
研究者
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