Treatment in Pediatric Obsessive-Compulsive Disorder

描述(由申请人提供)：这一竞争性的延续方案，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，即对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，一线初始治疗是使用SRI的单一疗法。这些药物的推荐剂量会使绝大多数患者出现临床上显著的残留症状。虽然强迫症专家通常建议使用认知行为疗法(CBT)来增加SRI部分应答者，但这一建议很少被遵循。另一种在社区实践中广泛使用但被强迫症专家认为是二线的强化策略是在SRI单一疗法的基础上增加非典型的神经镇静剂，如利培酮(RIS)。由于CBT和强化药物在相对收益和风险方面可能不同，因此在同一患者群体中对这两种强化策略与对照条件进行良好的对照比较是非常必要的。这项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，将实现这一至关重要的公共卫生目标。具体地说，利用135名8-17岁(45个/站点)的志愿者样本，初步诊断为对SRI药物治疗有部分反应的DSM-IV强迫症，我们建议进行一项为期5年的结果研究，评估以下药物强化的相对疗效：(1)强迫症特异性CBT；(2)利培酮(RIS)；(3)药片安慰剂(PBO)。我们建议对三种情况进行平衡的3(现场)×3(CBT、RIS或PBO)×4(评估点)12周比较。在研究结束时，所有参与者都将根据他们的临床状况得到关于进一步治疗的临床建议，并将自然地随访12个月。在急性治疗结束时，PBO无应答者将可以选择接受CBT或RIS开放治疗，由研究小组免费提供；CBT或RIS无应答者将获得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0、4、8、12周(第一阶段)进行盲法评估；在治疗后3、6、9和12个月进行自然主义随访时，IE而不是患者将进行盲法评估。通过检查CBT和RIS增强在同一患者群体中的相对收益和风险，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建议他们的儿科强迫症患者如何处理对SRLS的部分反应。

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.