Division of Child and Adolescent Psychiatry, School of Medicine, University of Maryland, 701 W Pratt Street, Baltimore, MD 21201, USA.
Child Adolesc Psychiatry Ment Health. 2013 Aug 15;7(1):31. doi: 10.1186/1753-2000-7-31.
Youth with serious mental illness may experience improved psychiatric stability with second generation antipsychotic (SGA) medication treatment, but unfortunately may also experience unhealthy weight gain adverse events. Research on weight loss strategies for youth who require ongoing antipsychotic treatment is quite limited. The purpose of this paper is to present the design, methods, and rationale of the Improving Metabolic Parameters in Antipsychotic Child Treatment (IMPACT) study, a federally funded, randomized trial comparing two pharmacologic strategies against a control condition to manage SGA-related weight gain.
The design and methodology considerations of the IMPACT trial are described and embedded in a description of health risks associated with antipsychotic-related weight gain and the limitations of currently available research.
The IMPACT study is a 4-site, six month, randomized, open-label, clinical trial of overweight/obese youth ages 8-19 years with pediatric schizophrenia-spectrum and bipolar-spectrum disorders, psychotic or non-psychotic major depressive disorder, or irritability associated with autistic disorder. Youth who have experienced clinically significant weight gain during antipsychotic treatment in the past 3 years are randomized to either (1) switch antipsychotic plus healthy lifestyle education (HLE); (2) add metformin plus HLE; or (3) HLE with no medication change. The primary aim is to compare weight change (body mass index z-scores) for each pharmacologic intervention with the control condition. Key secondary assessments include percentage body fat, insulin resistance, lipid profile, psychiatric symptom stability (monitored independently by the pharmacotherapist and a blinded evaluator), and all-cause and specific cause discontinuation. This study is ongoing, and the targeted sample size is 132 youth.
Antipsychotic-related weight gain is an important public health issue for youth requiring ongoing antipsychotic treatment to maintain psychiatric stability. The IMPACT study provides a model for pediatric research on adverse event management using state-of-the art methods. The results of this study will provide needed data on risks and benefits of two pharmacologic interventions that are already being used in pediatric clinical settings but that have not yet been compared directly in randomized trials.
Clinical Trials.gov NCT00806234.
患有严重精神疾病的年轻人在接受第二代抗精神病药物（SGA）治疗后，精神状态可能会更加稳定，但不幸的是，他们也可能会出现体重不健康增加的不良事件。针对需要持续接受抗精神病药物治疗的年轻人的减肥策略的研究非常有限。本文旨在介绍改善抗精神病药物治疗儿童代谢参数（IMPACT）研究的设计、方法和原理，该研究是一项由联邦政府资助的、针对两种药物策略与对照条件进行比较的随机试验，以管理 SGA 相关的体重增加。
本文描述了 IMPACT 试验的设计和方法考虑因素，并嵌入了与抗精神病药相关的体重增加相关的健康风险以及当前可用研究的局限性的描述。
IMPACT 研究是一项为期 6 个月的四地点、随机、开放标签、临床试验，纳入了年龄在 8-19 岁之间的超重/肥胖青少年，他们患有儿童精神分裂症谱系和双相谱系障碍、精神病性或非精神病性重度抑郁症或与自闭症相关的易激惹，在过去 3 年内接受抗精神病药物治疗时经历过临床显著体重增加的青少年被随机分配到以下三组之一：（1）转换抗精神病药物+健康生活教育（HLE）；（2）添加二甲双胍+HLE；或（3）HLE 且不改变药物。主要目标是比较每种药物干预与对照条件的体重变化（体重指数 z 评分）。关键次要评估包括体脂百分比、胰岛素抵抗、血脂谱、精神症状稳定性（由药师和盲法评估者独立监测）以及全因和特定原因停药。该研究正在进行中，目标样本量为 132 名青少年。
抗精神病药物相关的体重增加是一个重要的公共卫生问题，对于需要持续接受抗精神病药物治疗以维持精神状态稳定的年轻人来说尤其如此。IMPACT 研究为使用最先进的方法进行儿科不良事件管理的研究提供了一个模型。该研究的结果将提供关于两种已在儿科临床环境中使用但尚未在随机试验中直接比较的药物干预措施的风险和益处的急需数据。
ClinicalTrials.gov NCT00806234。
