Long-Term Effectiveness of Off-Label Risperidone Treatment in Children and Adolescents: A Randomized, Placebo-Controlled Discontinuation Study.

IF 1.5 4区 医学 Q2 PEDIATRICS Journal of child and adolescent psychopharmacology Pub Date : 2024-08-01 Epub Date: 2024-04-26 DOI:10.1089/cap.2023.0065
Mariken Dinnissen, Andrea Dietrich, Margreet Bierens, Judith H van der Molen, Anne M Verhallen, Wieske A Overbeek, Barbara J van den Hoofdakker, Yvette Roke, Pieter W Troost, Jan K Buitelaar, Pieter J Hoekstra
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Abstract

Objectives: Risperidone is commonly prescribed off-label in children and adolescents to manage disruptive behavior. This study aimed to investigate continued benefits of risperidone after at least 1 year of treatment and effects of discontinuation on physical health. Methods: Thirty-five youths (aged 6-18 years, intelligence quotient [IQ] >70) who were treated with risperidone for at least 1 year in regular clinical practice receiving outpatient care were randomly assigned to double-blind continuation of risperidone during 16 weeks or continuation for 2 weeks, gradual dose lowering over 6 weeks, and placebo for 8 weeks. Primary outcome was the total Disruptive Behavior (D-total) score of the parent-reported Nisonger Child Behavior Rating Form-Typical IQ (NCBRF-TIQ). Secondary outcome measures were the clinician-rated Clinical Global Impressions-Improvement scale (CGI-I), the parent, child, and teacher-rated Strengths and Difficulties Questionnaire (SDQ), the parent-rated Retrospective Modified Overt Aggression Scale (R-MOAS), and several health parameters (Udvalg for Kliniske Undersøgelser Side Effect Rating Scale [UKU-SERS], dyskinesia, akathisia, parkinsonism, body mass index (BMI), waist circumference, and laboratory outcomes). Mixed models for repeated measures were conducted for continuous outcomes and a chi-square test for the CGI-I. Results: Discontinuation of risperidone, as compared with continuation, was not associated with significant changes in parent-reported disruptive behaviors. However, discontinuation was related to significant deterioration in parent-rated verbal aggression, teacher-rated behavioral functioning, clinician-rated general functioning, and significant improvements in weight, BMI, waist circumference, and glucose, insulin, and prolactin levels. Although 56% of participants in the discontinuation group experienced relapse, causing premature withdrawal from the study, 44% was able to successfully discontinue risperidone. Conclusion: Discontinuation of risperidone was associated with deterioration on some, but not all behavioral measures according to this explorative study. Discontinuation was associated with important health gains. Despite long-term benefits of risperidone, attempts to withdraw risperidone should be undertaken in individual children. This is a crucial step in preventing harm and fostering health.

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儿童和青少年标示外利培酮治疗的长期疗效:随机安慰剂对照停药研究》。
目的:利培酮是儿童和青少年常用的非标签处方药,用于控制破坏性行为。本研究旨在调查利培酮在治疗至少一年后的持续疗效以及停药对身体健康的影响。研究方法35名青少年(6-18岁,智商[IQ]大于70)在接受门诊治疗的常规临床实践中接受利培酮治疗至少1年,他们被随机分配到双盲试验中,继续服用利培酮16周,或继续服用2周,在6周内逐渐降低剂量,并服用安慰剂8周。主要结果是家长报告的尼松格儿童行为评级表-典型智商(NCBRF-TIQ)中的破坏性行为总分(D-总分)。次要结果测量指标为临床医生评分的临床总体印象-改善量表(CGI-I)、家长、儿童和教师评分的优势和困难问卷(SDQ)、家长评分的回顾性修正过度攻击量表(R-MOAS)、以及一些健康参数(Udvalg for Kliniske Undersøgelser Side Effect Rating Scale [UKU-SERS], dyskinesia, akathisia, parkinsonism, body mass index (BMI), waist circumference, and laboratory outcomes)。对连续性结果采用重复测量混合模型,对 CGI-I 采用卡方检验。研究结果停用利培酮与继续用药相比,与家长报告的破坏行为的显著变化无关。然而,停药与家长评定的言语攻击性、教师评定的行为功能、临床医生评定的一般功能的显著恶化,以及体重、体重指数、腰围、血糖、胰岛素和催乳素水平的显著改善有关。虽然停药组中有 56% 的参与者复发,导致过早退出研究,但仍有 44% 的参与者能够成功停用利培酮。结论根据这项探索性研究,停用利培酮与某些行为指标的恶化有关,但并非所有行为指标。停药与重要的健康收益相关。尽管利培酮具有长期益处,但仍应针对个别儿童尝试停用利培酮。这是预防伤害和促进健康的关键一步。
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来源期刊
CiteScore
3.60
自引率
5.30%
发文量
61
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.
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