Anxiety and Recurrent Abdominal Pain in Children

儿童焦虑和反复腹痛

• 批准号: 7087693
• 负责人: John Vincent Campo
• 金额: $ 49.54万
• 依托单位: RESEARCH INST NATIONWIDE CHILDREN'S HOSP
• 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/7087693
• 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（由申请人提供）：本研究旨在确定选择性5-羟色胺再摄取抑制剂（SSRI）西酞普兰治疗小儿功能性复发性腹痛（RAP）的相对疗效、耐受性和安全性。RAP是常见的，通常出现在医疗环境中，并与痛苦，损害，过度使用服务，以及未充分治疗的共病焦虑和抑郁障碍的高发生率相关。没有一种单一的治疗方法被最终证明是有效的，RAP和共病焦虑和抑郁之间的关系知之甚少。最近完成的一项开放试验表明，西酞普兰是一种有希望的治疗RAP和共病焦虑和抑郁症。在四年的时间里，将通过临床转诊和办公室筛选招募100名7至18岁（含）的RAP儿童和青少年，随机分配至西酞普兰或安慰剂组进行8周的双盲治疗，然后返回转诊医生的护理。初始西酞普兰剂量为10 mg/天，一周后增加至20 mg/天，如果反应不理想且无显著副作用，则在第四周增加至40 mg/天。主要结局将是通过临床总体印象量表-改善（CGI-I）评估的总体改善和通过腹痛指数（API）评估的腹痛，该指数是一种经过充分验证的腹痛频率、持续时间和强度指标。将使用当前最先进的措施评估共病精神病理学，并将对焦虑和抑郁作为治疗反应介导剂的潜在作用进行二次检查，以及完成双盲阶段后西酞普兰治疗的持久性和耐受性。西酞普兰治疗RAP具有相对简单、规模经济和医疗环境可接受性的优点，并且无论患者、家庭成员或专业人员的具体归因如何，都有可能治疗RAP和共病焦虑和抑郁障碍。有限的排除标准以及在常规实践环境中提供的研究评估和干预措施提供了比典型疗效研究更大的外部效度，有可能为未来的治疗有效性和传播研究提供信息。