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.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目和 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 这是一项由研究者发起、医药赞助的 Abilify 公开试验，Abilify 是一种新型非典型精神安定药，用于治疗妥瑞氏症 (TD) 的运动和发声抽动。尽管损害性抽动仍然相对不常见，但现在已知 TD 比以前认为的更为常见。对于此类受试者，几乎没有理想的药理学选择，也没有现成的非药物治疗方法。 FDA 批准的治疗方法包括氟哌啶醇和匹莫齐特，这两种药物都有不良副作用，导致大多数患者停止治疗，尽管可以有效减少抽动。较新的治疗方法主要由非典型抗精神病药组成，据信这些药物患迟发性运动障碍的风险较低，但利培酮或奥氮平等抗精神病药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/拮抗活性。一种对抽动有效、耐受性良好的药物将代表着一个重要的进步。 这是一项公开试验，旨在提供初步数据。 这是一项为期 8 周的试验，每周进行一次访视。 参与者将是 7 至 18 岁（含），患有 DSM-IV TD 或慢性运动抽动障碍，未通过充分的替代药物试验，抽动会造成严重的痛苦或损害。 主要假设是阿立哌唑会减少抽动和抽动相关的损伤以及抽动的严重程度；第二个假设是，经常相关的强迫症 (OCD) 和注意力缺陷多动障碍 (ADHD) 症状也将分别通过 5-HT1a 部分激动和 D2 稳定而减轻。 参与者将接受近每周的随访，开始时剂量将最小，并根据需要滴定至与体重相关的最大剂量，对于体重 > 70 公斤的患者，剂量最高可达 10 毫克/天。