Safety and efficacy of dasotraline for patients with attention deficit/hyperactivity disorder: a systematic review and meta-analysis of 1594 patients including GRADE qualifications.

IF 3.5 3区医学 Q2 NEUROSCIENCES

Psychopharmacology Pub Date : 2025-01-01 Epub Date: 2024-12-19 DOI:10.1007/s00213-024-06723-5

Mohamed Ezzat M Mansour, Khalid Radwan Alsaadany, Mohamed Awad E Ahmed, Ahmed Ezzat Elmetwalli

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引用次数: 0

Abstract

Introduction: Attention-deficit/hyperactivity disorder (ADHD) is a complex neurodevelopmental disorder. It is one of the most common mental disorders in youth worldwide characterized by persistent overactivity and impulsivity/inattention symptoms associated with social and academic impairment. dasotraline has been suggested to play a pivotal role as a serotonin, norepinephrine, and dopamine reuptake inhibitor. This study aimed to create evidence from published randomized clinical trials (RCTs) about the benefits of dasotraline for ADHD patients.

Methods: A computer literature search (PubMed, Scopus, Web of Science, and Cochrane CENTRAL) was conducted. We included RCTs comparing dasotraline versus placebo. The primary outcome measure was the ADHD Rating Scale-IV score, pooled as the mean difference between the two groups from baseline to the endpoint. The secondary outcome measures were the ADHD Rating Scale-IV Inattention score, ADHD Rating Scale-IV Hyperactivity score.

Results: Five RCTs with a total of 1594 patients were included in this study. dasotraline showed a significant improvement in the primary outcome (MD -2.65, 95% CI [-4.14 to -1.17], P= 0.0004 CONCLUSION: The results showed that dasotraline demonstrated a significant improvement in both primary and secondary outcomes, establishing its efficacy as a novel treatment for ADHD symptoms. However, mild to moderate side effects were observed.

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dasotraline治疗注意缺陷/多动障碍患者的安全性和有效性：一项包含GRADE资格的1594例患者的系统回顾和荟萃分析

注意缺陷/多动障碍（ADHD）是一种复杂的神经发育障碍。它是全世界青少年中最常见的精神障碍之一，其特征是持续过度活动和冲动/注意力不集中症状，并伴有社交和学业障碍。达索曲林作为血清素、去甲肾上腺素和多巴胺再摄取抑制剂已被认为发挥关键作用。本研究旨在从已发表的随机临床试验（rct）中寻找证据，证明dasotraline对ADHD患者的益处。方法：计算机文献检索（PubMed, Scopus, Web of Science, Cochrane CENTRAL）。我们纳入了比较达索曲林和安慰剂的随机对照试验。主要结果测量是ADHD评定量表- iv评分，作为两组从基线到终点的平均差异。次要结果测量是ADHD评定量表- iv注意力不集中评分，ADHD评定量表- iv多动评分。结果：本研究共纳入5项rct，共1594例患者。结论：结果显示，达索曲林对主要转归均有显著改善（MD -2.65, 95% CI [-4.14 ~ -1.17]， P= 0.0004），达索曲林对主要转归和次要转归均有显著改善，确立了达索曲林治疗ADHD症状的新疗效。然而，观察到轻微到中度的副作用。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Psychopharmacology 医学-精神病学

CiteScore

7.10

自引率

5.90%

发文量

257

审稿时长

2-4 weeks

期刊介绍： Official Journal of the European Behavioural Pharmacology Society (EBPS) Psychopharmacology is an international journal that covers the broad topic of elucidating mechanisms by which drugs affect behavior. The scope of the journal encompasses the following fields: Human Psychopharmacology: Experimental This section includes manuscripts describing the effects of drugs on mood, behavior, cognition and physiology in humans. The journal encourages submissions that involve brain imaging, genetics, neuroendocrinology, and developmental topics. Usually manuscripts in this section describe studies conducted under controlled conditions, but occasionally descriptive or observational studies are also considered. Human Psychopharmacology: Clinical and Translational This section comprises studies addressing the broad intersection of drugs and psychiatric illness. This includes not only clinical trials and studies of drug usage and metabolism, drug surveillance, and pharmacoepidemiology, but also work utilizing the entire range of clinically relevant methodologies, including neuroimaging, pharmacogenetics, cognitive science, biomarkers, and others. Work directed toward the translation of preclinical to clinical knowledge is especially encouraged. The key feature of submissions to this section is that they involve a focus on clinical aspects. Preclinical psychopharmacology: Behavioral and Neural This section considers reports on the effects of compounds with defined chemical structures on any aspect of behavior, in particular when correlated with neurochemical effects, in species other than humans. Manuscripts containing neuroscientific techniques in combination with behavior are welcome. We encourage reports of studies that provide insight into the mechanisms of drug action, at the behavioral and molecular levels. Preclinical Psychopharmacology: Translational This section considers manuscripts that enhance the confidence in a central mechanism that could be of therapeutic value for psychiatric or neurological patients, using disease-relevant preclinical models and tests, or that report on preclinical manipulations and challenges that have the potential to be translated to the clinic. Studies aiming at the refinement of preclinical models based upon clinical findings (back-translation) will also be considered. The journal particularly encourages submissions that integrate measures of target tissue exposure, activity on the molecular target and/or modulation of the targeted biochemical pathways. Preclinical Psychopharmacology: Molecular, Genetic and Epigenetic This section focuses on the molecular and cellular actions of neuropharmacological agents / drugs, and the identification / validation of drug targets affecting the CNS in health and disease. We particularly encourage studies that provide insight into the mechanisms of drug action at the molecular level. Manuscripts containing evidence for genetic or epigenetic effects on neurochemistry or behavior are welcome.