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Anxiety and Recurrent Abdominal Pain in Children

儿童焦虑和反复腹痛

基本信息

批准号：
7279931
负责人：
John Vincent Campo
金额：
$ 44.9万
依托单位：
RESEARCH INST NATIONWIDE CHILDREN'S HOSP
依托单位国家：
美国
项目类别：
财政年份：
2004
资助国家：
美国
起止时间：
2004-07-01 至 2010-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7279931
关键词：
Abdominal Pain Adolescent Adverse effects Affect Age Anxiety Arts Caring Child Childhood Citalopram Classification Clinical Data Depressive disorder Development Disease Dose Double-Blind Method Effectiveness Exclusion Criteria Family Family member Frequencies Future Gender Goals Health Services Impairment Intervention Label Measures Mediator of activation protein Medical Mental Depression Mental Health Services Modeling Outcome Pathology Patients Phase Physicians Placebos Psyche structure Psychopathology Randomized Rate Recruitment Activity Recurrence Relative (related person)Risk Role Safety Screening procedure Selective Serotonin Reuptake Inhibitor Services Site Staging Tissues Treatment Effectiveness Week day depressive symptoms dissemination trial falls follow-up functional disability impression indexing medical specialties novel placebo controlled study response treatment site

项目摘要

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很常见，通常出现在医疗环境中，并与痛苦、损害、过度服务使用以及未充分治疗的共病焦虑和抑郁症的高发率有关。没有一种治疗方法被证实是有效的，RAP与共病焦虑和抑郁之间的关系尚不清楚。最近完成的一项公开试验表明，西酞普兰是一种很有希望的治疗RAP和共病焦虑和抑郁的方法。在四年的时间里，100名年龄在7至18岁之间的RAP儿童和青少年将通过临床转诊和办公室筛选招募，随机分配给西酞普兰或安慰剂进行8周的双盲治疗，然后返回到转诊医生的护理中。西酞普兰的初始剂量为10mg /天，一周后增加到20mg /天，如果反应不理想且无明显副作用，第四周增加到40mg /天。主要结果将是临床总体印象量表改善（CGI-I）评估的整体改善和腹痛指数（API）评估的腹痛，API是一种经过验证的腹痛频率、持续时间和强度的测量方法。将使用当前最先进的测量方法评估共病精神病理学，并将次要检查焦虑和抑郁作为治疗反应介质的潜在作用，以及完成双盲期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、规模经济和在医疗环境中可接受的优点，以及治疗RAP和共病焦虑和抑郁障碍的潜力，而不考虑患者、家庭成员或专业人员的具体归因。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效果和传播研究提供信息。