Treatment in Pediatric Obsessive-Compulsive Disorder

小儿强迫症的治疗

• 批准号: 6946382
• 负责人: JOHN S MARCH
• 金额: $ 45.35万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-09-30 至 2008-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6946382
• 关键词: adolescence (12-20); behavioral /social science research tag; child behavior disorders; child mental disorders; clinical research; cognitive behavior therapy; combination therapy; human subject; human therapy evaluation; longitudinal human study; mental disorder chemotherapy; middle childhood (6-11); obsessive compulsive disorder; patient oriented research; pediatrics; psychopharmacology; risperidone; serotonin inhibitor; adolescence (12-20); behavioral /social science research tag; child behavior disorders; child mental disorders; clinical research; cognitive behavior therapy; combination therapy; human subject; human therapy evaluation; longitudinal human study; mental disorder chemotherapy; middle childhood (6-11); obsessive compulsive disorder; patient oriented research; pediatrics; psychopharmacology; risperidone; serotonin inhibitor

DESCRIPTION (provided by applicant): This competing continuation proposal, Treatment of Pediatric OCD, addresses an important problem in the management of pediatric OCD, namely partial response to initial treatment with a serotonin reuptake inhibitor(SRI). For most pediatric OCD patients treated in the community, the first line initial treatment is monotherapy with an SRI. Recommended doses of these medications leave the great majority of patients with clinically significant residual symptoms. While OCD experts typically recommend augmenting SRI partial responders with cognitive-behavior therapy (CBT), this recommendation is seldom followed. An alternative augmentation strategy widely used in community practice but considered second-line by OCD experts is to add an atypical neuroleptic, such as risperidone (RIS), to SRI monotherapy. Because CBT and augmenting medications may differ in relative benefit and in risk, it is Imperative to conduct a well-controlled comparison of these two augmentation strategies against a control condition in the same patient population. The proposed study, which will be conducted at Duke University (John March), University of Pennsylvania (Martin Franklin) and Brown University (Henrietta Leonard), will meet this vital public health objective. Specifically, using a volunteer sample of 135 youth (45/site) age 8-17 with a primary DSM-IV diagnosis of OCD partially responsive to SRI pharmacotherapy, we propose to conduct a 5 year outcome study that will evaluate the relative efficacy of augmentation with: (1) OCD-specific CBT; (2) risperidone (RIS); and (3) pill placebo (PBO). We propose a balanced 3 (site) x 3 (CBT, RIS, or PBO) x 4 (assessment point) 12-week comparison of the three conditions. At study exit, all participants will be given clinical recommendations regarding further treatment based on their clinical status and will be followed up naturalistically for 12 additional months. PBO non-responders at the end of acute treatment will be given a choice of open treatment with either CBT or RIS delivered at no cost by the study team; non-responders to CBT or RIS will receive the alternative treatment delivered at no cost by the study team or, if they prefer, will be referred for community treatment. Blind assessments will be conducted for all patients at weeks 0, 4, 8, 12 (Phase I); the IE but not the patient will be blind for assessments during naturalistic follow-up, which will be conducted at 3, 6, 9 and 12 months post treatment. By examining the relative benefit and risk of CBT and RIS augmentation in the same patient population, the proposed study will provide an empirical basis for formulating practice guidelines. Health professionals then will be better able to advise their pediatric OCD patients regarding the management of partial response to SRls.

描述（由申请人提供）：该竞争性延续建议，小儿强迫症的治疗方法解决了小儿OCD管理的一个重要问题，即对血清素再摄取抑制剂（SRI）对初始治疗的部分反应（SRI）。对于大多数在社区中接受治疗的儿科强迫症患者，第一行初步治疗是SRI的单药治疗。这些药物的建议剂量使绝大多数患者患有临床显着的残留症状。尽管强迫症专家通常建议通过认知行为疗法（CBT）增加SRI部分响应者，但很少遵循此建议。在社区实践中广泛使用的另一种增强策略，但强迫症专家认为二线是在SRI单一疗法中添加一种非典型神经疗法，例如利培酮（RIS）。由于CBT和增强药物的相对利益可能有所不同，因此必须对同一患者人群中的这两种增强策略进行对照条件进行良好控制的比较。拟议的研究将在杜克大学（John March），宾夕法尼亚大学（Martin Franklin）和布朗大学（Henrietta Leonard）（Henrietta Leonard）进行。具体而言，使用135名青年（45个/部位）的志愿者样本8-17岁的主要DSM-IV诊断OCD对SRI药物疗法有部分反应的OCD诊断，我们建议进行5年的结果研究，以评估以下相对的增强功效：（1）OCD特定CBT； （2）利培酮（RIS）; （3）药丸安慰剂（PBO）。我们提出了平衡的3（站点）x 3（CBT，RIS或PBO）x 4（评估点）三个条件的12周比较。在研究退出时，所有参与者将根据其临床状况提供有关进一步治疗的临床建议，并自然而然地进行12个月的跟进。急性治疗结束时的PBO无反应者将通过研究团队免费提供CBT或RIS的开放式治疗；对CBT或RIS的非响应者将免费获得研究团队免费提供的替代治疗，或者（如果愿意）将被转介以进行社区治疗。在第0、4、8、12周（I阶段）的所有患者将对所有患者进行盲目评估； IE但不会在自然主义随访期间对患者进行评估，这将是在治疗后3、6、9和12个月进行的。通过检查同一患者人群中CBT和RIS增强的相对利益和风险，拟议的研究将为制定实践指南提供经验基础。然后，卫生专业人员将能够更好地向其儿科OCD患者提供有关SRL部分反应的管理。