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: 7718432
• 负责人: BARBARA Jane COFFEY
• 金额: $ 0.09万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-04-01 至 2009-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7718432
• 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的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 这是一项由制药商发起、制药商赞助的Abilify（一种新型非典型抗精神病药）治疗抽动秽语障碍（TD）运动和发声抽搐的开放性试验。TD是现在已知的比以前认为的更常见，虽然损害抽搐仍然相对罕见。对于这些受试者，几乎没有理想的药理学选择，也没有现成的非医学治疗。FDA批准的治疗包括氟哌啶醇和匹莫齐特，这两种药物都有不良反应，导致大多数患者停止治疗，尽管在减少抽搐方面有疗效。较新的治疗主要包括非典型的精神抑制剂，据信其具有较低的迟发性运动障碍风险，但精神抑制剂如利培酮或奥氮平与严重的体重增加和葡萄糖耐受不良有关。 据报道，阿立哌唑（Abilify）是体重中性的;它还对D2受体具有部分激动剂/拮抗剂活性。一种对抽搐有效的耐受性良好的药物将代表一个重要的进步。 这是一项开放试验，提供初步数据。 这是一项为期8周的试验，每周进行一次访视。 受试者年龄为7至18岁（含），患有DSM-IV TD或慢性运动性抽动障碍，未接受充分的替代药物试验，抽动导致严重的痛苦或损害。 主要假设是阿立哌唑将减少抽搐和抽搐相关的损害和抽搐的严重程度;次要假设是强迫症（OCD）和注意缺陷多动障碍（ADHD）症状，这是经常相关的，也将减少通过5-HT1a部分激动，和D2稳定，分别。 参与者将接受几乎每周一次的随访，剂量将在开始时最小化，并根据需要滴定至体重相关的最大值，对于体重> 70 kg的参与者，最大值为10 mg/天。