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.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 这是一项研究人员发起的药物赞助的Abilify的开放试验，一种新型非典型神经疗法，用于治疗Tourette障碍（TD）中的运动和声音。现在众所周知，TD比以前认为的要普遍得多，尽管损害的抽动仍然相对罕见。对于此类受试者，几乎没有理想的药理学选择，也没有随时可用的非医学治疗方法。 FDA批准的治疗方法由氟哌啶醇和偶突组组成，两者都有不良的不良反应，这导致大多数患者尽管降低了TIC，但仍停用治疗。较新的疗法主要由非典型神经疗法组成，据信迟到的敏感性风险较低，但是神经疗法（例如利培酮或奥氮平）与体重的大量增加和葡萄糖不耐症有关。 据报道，阿里皮拉唑（Abilify）是重量中性的；它还在D2受体上具有部分激动剂/拮抗剂活性。对抽动有疗效的耐受性良好的药物将代表一个重要的进步。 这是一个开放试验，可提供初步数据。 这是一项为期8周的试用期，每周访问。 参与者的年龄将为7至18岁（包括）DSM-IV TD或慢性运动疾病，他们未能对替代药物进行足够的试验，而TIC会造成严重的困扰或损害。 主要的假设是阿立哌唑将减少抽动和与抽动相关的障碍和抽动严重程度。次要假设是，强迫症（OCD）和注意力缺陷多动障碍（ADHD）症状经常相关，也将分别通过5-HT1A部分激动剂和D2稳定来降低。 参与者将每周进行几乎每周的随访，剂量在启动时将很少，并且根据需要的重量相关的最大值，最高为10毫克/天，重量> 70千克。