伏替西汀治疗儿童和青少年重度抑郁症:为期 6 个月和 18 个月的开放标签、灵活剂量、长期扩展研究。

IF 6 2区 医学 Q1 PEDIATRICS European Child & Adolescent Psychiatry Pub Date : 2024-09-06 DOI:10.1007/s00787-024-02560-1
Melissa P DelBello, Robert L Findling, Michael Huss, Oscar Necking, Maria L Petersen, Simon N Schmidt, Monika Rosen
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引用次数: 0

摘要

患有严重或复发性重度抑郁症(MDD)的儿童和青少年可能需要长期服用抗抑郁药,但有关长期治疗的安全性和耐受性数据却很有限。在一项针对儿童的随机安慰剂对照试验和另一项针对青少年的随机安慰剂对照试验中,伏替西汀组和安慰剂组均显示重度抑郁症状有所改善,但组间差异无统计学意义。为了深入了解伏替西汀在儿童患者中的长期安全性和耐受性,这两项研究的参与者参加了两项长期扩展研究:6个月(NCT02871297)和18个月(NCT03108625)。主要安全性指标包括不良事件(AEs)和哥伦比亚自杀严重程度量表(C-SSRS);有效性指标包括抑郁症状严重程度、认知功能和整体功能。在 6 个月的延长期中,662 名患者中有 61% 出现了治疗突发 AE(TEAE),其中最常见的是恶心(20.8%);2.1% 出现了严重 AE(SAE),6% 因 TEAE 而退出治疗。在随后为期 18 个月的延长治疗中(n = 94),51% 的患者出现了 TEAE,最常见的是头痛(13.8%);没有 SAE 报告。根据C-SSRS,在6个月和18个月的研究中,分别有94%和96%的患者没有自杀意念或行为。在延长期研究中,患者的抑郁症状、认知功能和整体功能继续得到改善,在每项研究结束时,均有超过 50% 的患者病情得到缓解,与先导试验中的治疗方法无关。总体而言,伏替西汀在儿童多发性抑郁症患者中仍具有良好的耐受性,这些患者继续接受了长期的延伸研究,且未观察到自杀意念风险的增加。
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Vortioxetine in children and adolescents with major depressive disorder: 6-month and 18-month open-label, flexible-dose, long-term extension studies.

Children and adolescents with severe or relapsing major depressive disorder (MDD) may require long-term antidepressant use, but safety and tolerability data on long-term treatment are limited. In a randomized, placebo-controlled trial in children and another in adolescents, vortioxetine and placebo groups showed improvement in MDD symptoms without statistically significant differences between groups. To gain insights on long-term safety and tolerability of vortioxetine in pediatric patients, participants from these two studies were enrolled in two long-term extension studies: 6 months (NCT02871297) followed by another 18 months (NCT03108625). Key safety measures included adverse events (AEs) and Columbia-Suicide Severity Rating Scale (C-SSRS); effectiveness measures included depression symptom severity, cognitive function, and overall functioning. Among the 662 patients in the 6-month extension, 61% experienced a treatment-emergent AE (TEAE), with the most common being nausea (20.8%); 2.1% had a serious AE (SAE), and 6% withdrew because of TEAEs. In the following 18-month extension (n = 94), 51% of patients experienced a TEAE, with the most common being headache (13.8%); no SAEs were reported. Based on the C-SSRS, 94% and 96% of patients reported no suicidal ideation or behavior in the 6- and 18-month studies, respectively. During the extension studies, patients continued to show improvement in depressive symptoms and cognitive and overall functioning, with > 50% of patients in remission at the end of each study, regardless of study treatment in the lead-in trial. Overall, vortioxetine remained well tolerated in pediatric patients with MDD who continued in the long-term extension studies with no observed increased risk in suicidal ideation.

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来源期刊
CiteScore
12.80
自引率
4.70%
发文量
186
审稿时长
6-12 weeks
期刊介绍: European Child and Adolescent Psychiatry is Europe''s only peer-reviewed journal entirely devoted to child and adolescent psychiatry. It aims to further a broad understanding of psychopathology in children and adolescents. Empirical research is its foundation, and clinical relevance is its hallmark. European Child and Adolescent Psychiatry welcomes in particular papers covering neuropsychiatry, cognitive neuroscience, genetics, neuroimaging, pharmacology, and related fields of interest. Contributions are encouraged from all around the world.
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