Anxiety and Recurrent Abdominal Pain in Children

儿童焦虑和反复腹痛

• 批准号: 6820801
• 负责人: John Vincent Campo
• 金额: $ 46.09万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-07-01 至 2008-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6820801
• 关键词: abdomen; adolescence (12-20); age difference; antidepressants; anxiety; chemotherapy; citalopram; clinical research; clinical trials; comorbidity; depression; gender difference; health care referral /consultation; human subject; human therapy evaluation; mental disorder chemotherapy; mental disorder diagnosis; middle childhood (6-11); pain; patient oriented research; pediatrics; primary care physician; psychopathology; psychosomatic disorders; serotonin inhibitor

DESCRIPTION (provided by applicant): This study aims to determine the relative efficacy, tolerability, and safety of the selective serotonin reuptake inhibitor (SSRI) citalopram in the treatment of pediatric functional recurrent abdominal pain (RAP). RAP is common, typically presents in medical settings, and is associated with suffering, impairment, excess service use, and high rates of inadequately treated comorbid anxiety and depressive disorders. No single treatment has been conclusively demonstrated to be efficacious, and the relationship between RAP and comorbid anxiety and depression is poorly understood. A recently completed open trial suggests that citalopram is a promising treatment for RAP and comorbid anxiety and depression. Over a four year period, 100 children and adolescents with RAP between the ages of 7 and 18 years, inclusive, will be recruited by clinical referral and office screening, randomly assigned to citalopram or placebo for 8 weeks of double blind treatment, then returned to the care of the referring physician. Initial citalopram dose will be 10 mg/day, increasing to 20 mg/day after one week, and to 40 mg/day at week four if response is suboptimal and there are no significant side effects. Primary outcomes will be global improvement assessed by the Clinical Global Impression Scale-Improvement (CGI-I) and abdominal pain assessed with the Abdominal Pain Index (API), a well-validated measure of abdominal pain frequency, duration, and intensity. Comorbid psychopathology will be assessed using current state of the art measures and the potential role of anxiety and depression as mediators of treatment response will be secondarily examined, as well as the durability and tolerability of citalopram treatment following completion of the double-blind phase. Citalopram treatment of RAP offers advantages of relative simplicity, economy of scale, and acceptability within the medical setting, as well as the potential to treat both RAP and comorbid anxiety and depressive disorders regardless of the specific attributions of patients, family members, or professionals. Limited exclusion criteria and the delivery of study assessments and interventions within routine practice settings provide for considerably greater external validity than the typical efficacy study, with the potential to inform future studies of treatment effectiveness and dissemination.

描述(申请人提供)：这项研究旨在确定选择性5-羟色胺再摄取抑制剂(SSRI)西酞普兰治疗儿童功能性再发性腹痛(RAP)的相对有效性、耐受性和安全性。RAP很常见，通常出现在医疗环境中，并与痛苦、损伤、过度使用服务以及未得到充分治疗的并发焦虑和抑郁障碍的高比率有关。没有一种单一的治疗方法被确凿地证明是有效的，而且RAP与共病的焦虑和抑郁之间的关系也鲜为人知。最近完成的一项公开试验表明，西酞普兰是一种很有前途的治疗说唱音乐及其伴发的焦虑和抑郁的方法。在四年的时间里，100名7岁至18岁(含)的RAP儿童和青少年将被临床转诊和办公室筛查招募，随机分配到西酞普兰或安慰剂进行8周的双盲治疗，然后返回转诊医生的护理。西酞普兰的初始剂量为10毫克/天，一周后增加到20毫克/天，如果疗效不佳且没有明显副作用，则在第四周增加到40毫克/天。主要结果将是通过临床总体印象改善量表(CGI-I)评估全球改善情况，并使用腹痛指数(API)评估腹痛，腹痛指数是腹痛频率、持续时间和强度的有效衡量标准。将使用目前最先进的措施评估并存的精神病理学，并将次级检查焦虑和抑郁作为治疗反应的中介的潜在作用，以及在完成双盲阶段后西酞普兰治疗的耐受性和耐受性。西酞普兰治疗RAP具有相对简单、规模经济和在医疗环境中可接受的优势，并且无论患者、家庭成员或专业人员的具体属性如何，都有可能治疗RAP和共病的焦虑和抑郁障碍。有限排除标准和在常规实践环境中提供研究评估和干预措施提供了比典型疗效研究更高的外部有效性，并有可能为未来关于治疗有效性和传播的研究提供信息。