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

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）：这一竞争性延续提案，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SRI单药治疗。这些药物的推荐剂量使绝大多数患者具有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）来增强SRI部分应答者，但很少有人遵循这一建议。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增强策略是在SRI单一疗法中加入非典型神经阻滞剂，如利培酮（RIS）。由于CBT和增强药物的相对获益和风险可能不同，因此必须在同一患者人群中对这两种增强策略进行对照良好的比较。这项拟议中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（亨里埃塔伦纳德）进行，将满足这一至关重要的公共卫生目标。具体而言，使用135名年龄为8-17岁的青少年（45名/研究中心）志愿者样本，其主要DSM-IV诊断为对SRI药物治疗有部分反应的OCD，我们建议进行一项为期5年的结局研究，该研究将评估以下药物增强的相对疗效：（1）OCD特异性CBT;（2）利培酮（RIS）;（3）药丸安慰剂（PBO）。我们建议对这三种情况进行平衡的3（研究中心）x 3（CBT、RIS或PBO）x 4（评估点）12周比较。研究退出时，所有参与者将根据其临床状况获得有关进一步治疗的临床建议，并将接受额外12个月的自然随访。在急性治疗结束时，PBO无应答者将被给予开放治疗的选择，由研究团队免费提供CBT或RIS; CBT或RIS无应答者将接受研究团队免费提供的替代治疗，或者如果他们愿意，将被转诊接受社区治疗。将在第0、4、8、12周（I期）对所有患者进行盲态评估;在治疗后3、6、9和12个月进行的自然随访期间，将对IE而不是患者进行盲态评估。通过检查CBT和RIS增强在同一患者人群中的相对获益和风险，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童强迫症患者对SRLs的部分反应的管理。