ARIPIPRAZOLE IN CHILDREN AND ADOLESCENTS WITH TOURETTE'S DISORDER

阿立哌唑治疗抽动秽语症儿童和青少年

• 批准号: 7605751
• 负责人: BARBARA Jane COFFEY
• 金额: $ 0.51万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-04-01 至 2008-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7605751
• 关键词: 18 year old; Adolescent; Adverse effects; Agonist; Antipsychotic Agents; Attention deficit hyperactivity disorder; Child; Chronic; Computer Retrieval of Information on Scientific Projects Database; DSM-IV; Data; Distress; Dopamine D2 Receptor; Dose; Funding; Gilles de la Tourette syndrome; Glucose Intolerance; Grant; Haloperidol; Impairment; Institution; Medical; Motor; Motor Tic Disorders; Obsessive-Compulsive Disorder; Otsuka brand of aripiprazole; Participant; Patients; Pharmaceutical Preparations; Pimozide; Reporting; Research; Research Personnel; Resources; Risk; Risperidone; Severities; Source; Symptoms; Tardive Dyskinesia; United States Food and Drug Administration; United States National Institutes of Health; Visit; Vocal Tics; Weight; Weight Gain; aripiprazole; day; follow-up; novel; olanzapine; tic-related; week trial

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is an investigator-initiated, pharmaceutically-sponsored open trial of Abilify, a novel atypical neuroleptic, for the treatment of motor and vocal tics in Tourette's disorder (TD). TD is now known to be substantially more common than previously believed, although impairing tics are still relatively uncommon. For such subjects, there are few desirable pharmacological options, and no readily available non-medical treatments. FDA approved treatments consist of haloperidol and pimozide, both of which have undesirable adverse effects, which results in most patients discontinuing treatment despite efficacy in tic reduction. Newer treatments have consisted mostly of atypical neuroleptics which are believed to have lower risks of tardive dyskinesia, but neuroleptics such as risperidone or olanzapine have been associated with profound weight gain and glucose intolerance. Aripiprazole (Abilify) is reported to be weight-neutral; it also has partial agonist/antagonist activity at the D2 receptor. A well-tolerated medication that has efficacy against tics would represent an important advance. This is an open trial to provide preliminary data. It is an 8-week trial with weekly visits. Participants will be 7 to 18 years old (inclusive) with DSM-IV TD or chronic motor tic disorder, who have failed an adequate trial of alternative medications, with tics that are causing significant distress or impairment. The primary hypothesis is that aripiprazole will reduce tics and tic-related impairment and tic severity; secondary hypotheses are that obsessive-compulsive disorder (OCD) and attention deficit hyperactivity disorder (ADHD) symptoms, which are frequently associated, will also be reduced through 5-HT1a partial agonism, and D2 stabilization, respectively. Participants will undergo nearly weekly follow-up, doses will be minimal at initiation and titrated as needed to weight-related maxima of up to 10 mg/day for those weighing > 70 kg.

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这是一项由研究人员发起、药物赞助的公开试验，Abilify是一种新型非典型抗神经药，用于治疗多发性抽动症(TD)的运动和声带痉挛。现在已知TD比以前认为的要常见得多，尽管损害抽动的情况仍然相对少见。对于这类受试者，几乎没有理想的药理选择，也没有现成的非药物治疗方法。FDA批准的治疗包括氟哌啶醇和吡莫齐特，这两种药物都有不良副作用，导致大多数患者尽管在减少抽动方面有效，但仍停止治疗。新的治疗方法主要是非典型的神经抗精神病药物，据信迟发性运动障碍的风险较低，但利培酮或奥氮平等神经抗精神病药物与严重的体重增加和葡萄糖耐量异常有关。阿立哌唑(阿立哌唑，Abilify)被报道为体重中性；它还具有D2受体的部分激动剂/拮抗剂活性。一种耐受性良好、对抽搐有效的药物将代表着一项重要的进步。 这是一项公开试验，旨在提供初步数据。这是一个为期8周的试验，每周访问一次。参与者的年龄为7至18岁(含)，患有DSM-IV TD或慢性运动抽动障碍，他们没有通过足够的替代药物试验，抽搐造成严重的痛苦或损害。主要的假设是阿立哌唑将减少抽动和抽动相关的损害和抽动的严重程度；次要假设是强迫症(OCD)和注意缺陷多动障碍(ADHD)症状，这两个经常相关的症状也将分别通过5-HT1A部分激动和D2稳定来减少。参与者将接受几乎每周一次的跟踪，开始时剂量将是最小的，并根据需要进行滴定，以达到体重相关的最大值，体重70公斤的人每天最高可达10毫克。