Treatment in Pediatric Obsessive-Compulsive Disorder

描述（由申请人提供）：这个竞争性的延续提案，儿童强迫症的治疗，解决了儿童强迫症管理中的一个重要问题，即5 -羟色胺再摄取抑制剂（SRI）初始治疗的部分反应。对于大多数在社区接受治疗的儿童强迫症患者，一线初始治疗是单药治疗和SRI。这些药物的推荐剂量给绝大多数患者留下了临床显著的残留症状。虽然强迫症专家通常建议用认知行为疗法（CBT）来增加SRI部分反应者，但这一建议很少被遵循。在社区实践中广泛使用但被强迫症专家认为是二线的另一种增强策略是在SRI单药治疗中添加非典型抗精神病药，如利培酮（RIS）。由于CBT和增强药物可能在相对获益和风险上有所不同，因此有必要在同一患者群体的控制条件下对这两种增强策略进行良好的对照比较。拟议的研究将在杜克大学（约翰·马奇）、宾夕法尼亚大学（马丁·富兰克林）和布朗大学（亨丽埃塔·伦纳德）进行，将实现这一重要的公共卫生目标。具体来说，我们选取了135名年龄在8-17岁的青少年（45人/个站点）作为志愿者样本，他们在DSM-IV中被诊断为强迫症，对SRI药物治疗有部分反应。我们建议进行一项为期5年的结果研究，以评估增强强迫症的相对疗效：(1)强迫症特异性CBT；(2)利培酮（RIS）；(3)药丸安慰剂（PBO）。我们建议对三种情况进行为期12周的3（部位）× 3 （CBT、RIS或PBO） × 4（评估点）的平衡比较。在研究结束时，所有参与者将根据其临床状况给出进一步治疗的临床建议，并将进行12个月的自然随访。在急性治疗结束时，PBO无应答者将选择开放治疗，由研究小组免费提供CBT或RIS；对CBT或RIS无反应的患者将接受由研究小组免费提供的替代治疗，或者，如果他们愿意，将被转介到社区治疗。所有患者将在第0、4、8、12周（I期）进行盲评估；在治疗后3、6、9和12个月进行的自然随访中，IE（而不是患者）将进行盲测。通过检查CBT和RIS增强在同一患者群体中的相对获益和风险，本研究将为制定实践指南提供经验基础。卫生专业人员将能够更好地建议他们的儿童强迫症患者对srl的部分反应的管理。

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.