儿童重度抑郁症治疗的伏尔提奥塞丁:为期12周的随机化,安慰剂控制的研究
Michael Huss1, Robert L Findling2, Melissa P DelBello3
1University Medicine of Gutenberg University, Mainz, Germany.
JAACAP open
|September 9, 2025
概括
这项研究发现,与安慰剂相比,西在7至11岁儿童中没有显著改善主要抑郁症症状. 安全性和耐受性与成人数据相似,没有发现重大问题.
科学领域:
- 儿科精神病学 儿科精神病学
- 药理学 药理学是指药理学的学科.
- 临床试验 临床试验
背景情况:
- 大型抑郁症 (MDD) 是儿童群体的一个重大问题.
- 对于患有MDD的儿童,治疗选择有限,因此需要对新药疗法进行研究.
- 伏尔托克塞丁已在成人MDD中表现出有效性,但其在年幼儿童中的使用需要进行研究.
研究的目的:
- 评估7至11岁儿童诊断患有MDD的沃尔提奥塞丁的疗效,安全性和耐受性.
- 为了比较vortioxetine的有效性与安慰剂和素在这个儿科群体.
- 为了评估与儿童使用西相关的治疗出现的不良事件.
主要方法:
- 随机,双盲,安慰剂对照试验是在单盲引入期后进行的.
- 症状不完全改善的患者接受了简短的社会心理干预,以及安慰剂,伏尔西丁 (10毫克/天或20毫克/天) 或西丁 (20毫克/天).
- 主要终点是从基线到第8周的儿童抑郁评分表 (CDRS-R) 总得分的变化.
主要成果:
- 在西 (平均10mg和20mg剂量) 和安慰剂 (p=0.0937) 之间没有观察到CDRS-R得分改善的统计学上显著差异.
- 根据临时分析,在fluoxetine手臂的注册被提前停止.
- 47%的患者报告了治疗出现的不良事件,恶心在西组中最常见 (11.1%-12.6%).
结论:
- 西在治疗7至11岁儿童重度抑郁症方面没有显示出统计学意义上的有效性.
- 在这个儿科队列中,西的安全性和耐受性概况与青少年和成年人的研究结果一致.
- 在研究期间,没有发现超出预期的重大安全问题.
相关概念视频
01:23Antidepressant Drugs: MAOIs and Other Agents
831
Atypical antidepressants, including bupropion (Wellbutrin), mirtazapine (Remeron), nefazodone (Serzone), trazodone (Desyrel), and vilazodone (Viibryd), offer unique mechanisms of action. Bupropion weakly inhibits dopamine and norepinephrine reuptake, aiding depression treatment and smoking cessation, with a low risk of sexual dysfunction. Mirtazapine enhances serotonin and norepinephrine neurotransmission, leading to sedation, increased appetite, and weight gain. As a result, it helps treat...
831
01:25Antidepressant Drugs: Overview
1.4K
Antidepressant drugs are a class of medications primarily used for treating various mood disorders, including major depression, anxiety disorders, and other related conditions. These medicines work by modulating the neurotransmitter balance within the brain, alleviating depressive symptoms. Antidepressants can be broadly categorized into several groups according to their mechanism of action and chemical structure: Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin-Norepinephrine...
1.4K
01:26Pharmacokinetics in Pediatric Patients: Drug Excretion
214
In pediatric medicine, understanding the renal function and drug elimination nuances is crucial for administering safe and effective treatments. Newborns, in particular, display markedly slower renal functions than adults, profoundly affecting how drugs are cleared from their bodies. This slower drug clearance requires clinicians to extend the dosing intervals for many medications to prevent drug accumulation and toxicity while ensuring therapeutic efficacy.One key area where these adjustments...
214
01:24Pharmacokinetics in Pediatric Patients: Drug Metabolism
195
In pediatric care, understanding the nuances of hepatic drug metabolism is crucial, as it significantly differs from that of adults. This divergence is primarily due to the developmental stage of drug-metabolizing enzymes, which affects how medications are processed in the body. In neonates, for instance, the activity of Phase I enzymes—critical for the initial breakdown of drugs—is markedly reduced, functioning at just 20–40% of the levels seen in adults. This reduction poses...
195
01:30Electroconvulsive Therapy
927
Electroconvulsive therapy (ECT), or shock therapy, remains a critical biomedical intervention for severe, treatment-resistant depression. While its origins can be traced back to Hippocrates' observations that malaria-induced convulsions alleviated mental illness, modern ECT has evolved significantly from its earlier, more primitive applications. First introduced in 1938 by Ugo Cerletti and his colleagues, ECT involves inducing controlled seizures using electrical currents. In its early...
927
01:28Antidepressant Drugs: Tricyclics, SSRIs, and SNRIs
1.4K
Tricyclic Antidepressants (TCAs), including Desipramine (Norpramin), Imipramine (Tofranil), Clomipramine (Anafranil), and Amitriptyline (Elavil), inhibit serotonin and norepinephrine reuptake and also block other receptors. They are used for depression, pain conditions, and insomnia. Common adverse effects include anticholinergic effects, sedation, orthostatic hypotension, and weight gain. They have a narrow therapeutic window and so require plasma-level monitoring. Abrupt discontinuation can...
1.4K