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）西氧威普中选择性的相对功效，耐受性和安全性，以治疗小儿功能性复发性腹痛（RAP）。说唱很常见，通常在医疗环境中呈现，并且与痛苦，障碍，服务过多以及较高治疗的合并症焦虑和抑郁症的率相关。没有最终证明单一治疗是有效的，并且对RAP与合并症和抑郁症之间的关系知之甚少。最近完成的开放试验表明，西妥位氨答兰是对RAP和合并焦虑和抑郁的有前途的治疗方法。在四年的时间里，将有100个年龄在7至18岁之间的RAP的儿童和青少年，包括临床转诊和办公室筛查，随机分配给Citalopram或安慰剂，进行8周的双盲治疗，然后返回给推荐医师的照顾。最初的西妥位型剂量为10毫克/天，一周后增加到20 mg/天，如果反应是次优的，则在第四周的40 mg/天，没有显着的副作用。主要结果将是通过临床全球印象量表改器（CGI-I）评估的全球改善，并通过腹痛指数（API）评估腹痛，这是对腹痛频率，持续时间和强度的验证量的验证。将使用当前的最新措施来评估合并症的心理病理学，焦虑和抑郁作为治疗反应的介体的潜在作用将进行第二次检查，以及在完成双盲阶段完成后西妥位治疗的耐用性和耐受性。 Citalopram对RAP的治疗可提供相对简单，规模经济和医疗环境中可接受性的优势，以及无论患者，家庭成员或专业人员的具体归因如何，都有可能治疗RAP和合并症焦虑和抑郁症。有限的排除标准以及在常规练习环境中的研究评估和干预措施提供的外部有效性比典型效力研究更大，并有可能为未来的治疗效率和传播研究提供信息。