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IF 1.5 4区医学 Q2 PEDIATRICS

Journal of child and adolescent psychopharmacology Pub Date : 2025-02-27 DOI:10.1089/cap.2024.0138

Ann Childress, Kobby Asubonteng, Georgette Cox, Jami Earnest, Kimberley Hayman, Ilmiya Yarullina, Jonathan Rubin

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引用次数: 0

摘要

简介：维洛沙嗪缓释片（VLX-ER）作为单一疗法可有效治疗注意力缺陷/多动障碍（ADHD），当精神刺激剂疗法无法提供足够的治疗反应时，通常会尝试作为附加疗法。这项第 4 期开放标签研究评估了 VLX-ER 与优化的精神兴奋剂一起用于多动症儿童患者的安全性、耐受性和疗效。同时还评估了VLX-ER的早晚用药情况。研究方法在为期4周的筛查期间，精神刺激剂反应不充分的儿童和青少年（6-17岁）（研究者评估的ADHD评分量表-5 [ADHD-RS-5]得分≥24分，临床整体印象-疾病严重程度[CGI-S]得分≥3分）接受了剂量灵活的VLX-ER，每天一次，早上服用（第14周）或晚上服用（第5-8周），同时服用一种精神刺激剂。与基线相比，对安全性（主要结果）和疗效进行了评估。结果56名参与者（26名儿童；30名青少年）参加了研究，48人（85.7%）完成了研究。联合疗法的耐受性良好，只有两名参与者（3.6%）因不良反应（AEs）而退出。最常见的不良反应是头痛（17.9%）、食欲下降（12.5%）和上呼吸道感染（10.7%）。研究者评估的ADHD-RS-5评分（基线：37.2 ± 8.4）的平均值（±标准差）在第4周和第8周分别逐渐改善了-13.5 ± 9.7分和-18.2 ± 10.0分（p < 0.0001）。同样，CGI-S 评分（基线：4.4 ± 0.6）在第 4 周改善了 -0.9 ± 0.9 分，在第 8 周改善了 -1.4 ± 1.1 分（p < 0.0001）。家长评估量表（包括对早晚多动症行为和睡眠障碍的评分）显示，无论VLX-ER是早上用药（第4周）还是晚上用药（第8周），相对于基线都有显著改善。结论VLX-ER与精神刺激剂联合治疗的安全性和耐受性均可接受，与刺激剂单一疗法相比，早晚多动症行为和睡眠障碍均有所改善。服用 VLX-ER 的时间（早上或晚上）似乎不会影响安全性、药物反应或睡眠改善。

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Viloxazine Extended-Release Administered With Psychostimulants in Children and Adolescents With Attention-Deficit/Hyperactivity Disorder: A Phase 4, Open-Label Trial.

Introduction: Viloxazine extended-release (VLX-ER) is effective as monotherapy for attention-deficit/hyperactivity disorder (ADHD), and is often tried as an add-on treatment when psychostimulant therapy fails to provide an adequate treatment response. This phase 4, open-label study evaluated safety, tolerability, and efficacy of VLX-ER with optimized psychostimulants in pediatric participants with ADHD. Morning versus evening VLX-ER use was also evaluated. Methods: Children and adolescents (6-17 years) experiencing inadequate psychostimulant response (investigator-assessed ADHD Rating Scale-5 [ADHD-RS-5] score ≥24 and Clinical Global Impression-Severity of Illness [CGI-S] scores ≥3) during a 4-week screening period received flexibly-dosed VLX-ER, taken once daily in the morning (weeks 14) or evening (weeks 5-8), concomitantly with a psychostimulant. Safety (primary outcome) and efficacy were evaluated relative to baseline. Results: Fifty-six participants (26 children; 30 adolescents) enrolled, and 48 (85.7%) completed the study. Combination therapy was well tolerated, with only two participants (3.6%) withdrawing due to adverse events (AEs). The most commonly reported AEs were headache (17.9%), decreased appetite (12.5%), and upper respiratory tract infection (10.7%). Mean ± standard deviation investigator-assessed ADHD-RS-5 scores (baseline: 37.2 ± 8.4) improved progressively by -13.5 ± 9.7 points at week 4 and -18.2 ± 10.0 points at week 8 (p < 0.0001 each). Likewise, CGI-S scores (baseline: 4.4 ± 0.6) improved by -0.9 ± 0.9 at week 4 and -1.4 ± 1.1 at week 8 (p < 0.0001 each). Parent-assessed scales, including ratings of morning and evening ADHD behaviors and sleep disturbances, showed significant improvement relative to baseline regardless of morning (week 4) or evening (week 8) VLX-ER dosing. Conclusion: Combined treatment with VLX-ER and psychostimulant therapy showed acceptable safety and tolerability, with improvement in morning and evening ADHD behaviors and sleep disturbances relative to stimulant monotherapy. Timing of VLX-ER administration (morning or evening) did not appear to affect safety, drug response, or sleep improvement.

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来源期刊

Journal of child and adolescent psychopharmacology 医学-精神病学

CiteScore

3.60

自引率

5.30%

发文量

审稿时长

>12 weeks

期刊介绍： Journal of Child and Adolescent Psychopharmacology (JCAP) is the premier peer-reviewed journal covering the clinical aspects of treating this patient population with psychotropic medications including side effects and interactions, standard doses, and research on new and existing medications. The Journal includes information on related areas of medical sciences such as advances in developmental pharmacokinetics, developmental neuroscience, metabolism, nutrition, molecular genetics, and more. Journal of Child and Adolescent Psychopharmacology coverage includes: New drugs and treatment strategies including the use of psycho-stimulants, selective serotonin reuptake inhibitors, mood stabilizers, and atypical antipsychotics New developments in the diagnosis and treatment of ADHD, anxiety disorders, schizophrenia, autism spectrum disorders, bipolar disorder, eating disorders, along with other disorders Reports of common and rare Treatment Emergent Adverse Events (TEAEs) including: hyperprolactinemia, galactorrhea, weight gain/loss, metabolic syndrome, dyslipidemia, switching phenomena, sudden death, and the potential increase of suicide. Outcomes research.