Treatment of affective dysregulation in ADHD with guanfacine: study protocol.

Frontiers in child and adolescent psychiatry Pub Date : 2025-03-28 eCollection Date: 2025-01-01 DOI:10.3389/frcha.2025.1547672
Johanna Waltereit, Anne Uhlmann, Christos Tarassidis, Ulrich Preuss, Veit Roessner, Robert Waltereit
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Abstract

The early onset, high prevalence, persistence and comorbidity of developmental disorders make affective dysregulation (AD) in childhood and adolescence one of the conditions with the greatest psychosocial burden and economic impact on society. Despite ongoing research, there remains a substantial need to optimize individualized treatment strategies to improve treatment outcomes and alleviate subjective distress and economic costs. The objective of this study is to investigate psychopathological markers of AD in children and adolescents with attention-deficit/hyperactivity disorder (ADHD) treated with the drug guanfacine as part of routine clinical care. These ADHD patients typically have not responded adequately to methylphenidate or other stimulant treatment. This study will employ a multicenter, single-arm design to evaluate the effects of guanfacine on AD symptoms in n = 40 patients of children and adolescents receiving regular ADHD treatment. The findings of this study are expected to address the hypothesis that guanfacine provides beneficial effects on symptoms of AD in addition to its effects on symptoms of ADHD.

Public clinical trial registry: Affective Dysregulation (AD) in Children With ADHD Treated by Guanfacin, ClinicalTrials.gov ID NCT04016207.

Abstract Image

胍法辛治疗ADHD的情感性失调:研究方案。
发育障碍的早发性、高患病率、持续性和共病性使儿童和青少年的情感性失调(AD)成为最严重的社会心理负担和社会经济影响之一。尽管正在进行研究,但仍然需要优化个性化治疗策略,以改善治疗效果,减轻主观痛苦和经济成本。本研究的目的是研究使用药物胍法辛作为常规临床护理的一部分治疗ADHD的儿童和青少年AD的精神病理标志物。这些ADHD患者通常对哌甲酯或其他兴奋剂治疗没有充分的反应。本研究将采用多中心、单臂设计,评估n = 40例接受常规ADHD治疗的儿童和青少年患者中胍法辛对AD症状的影响。本研究的结果有望解决胍法辛除了对ADHD症状有作用外对AD症状有有益作用的假设。公共临床试验注册:冠法辛治疗ADHD儿童的情感性失调(AD), ClinicalTrials.gov ID NCT04016207。
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