TREATMENT OF EARLY ONSET SCHIZOPHRENIA SPECTRUM (TEOSS)

早发性精神分裂症谱系 (TEOSS) 的治疗

• 批准号: 6288296
• 负责人: Jean A Frazier
• 金额: $ 36.89万
• 依托单位: MCLEAN HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-09-19 至 2006-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6288296
• 关键词: adolescence (12-20); antipsychotic agents; blood chemistry; blood lipid; body weight; clinical trials; cognition disorders; cooperative study; data collection methodology /evaluation; disease /disorder onset; drug adverse effect; electrocardiography; extrapyramidal disorder; glucose metabolism; human subject; human therapy evaluation; liver function; longitudinal human study; mental disorder chemotherapy; middle childhood (6-11); mood disorders; morpholine; neuropsychological tests; patient oriented research; pediatric pharmacology; pharmacokinetics; prolactin; risperidone; schizophrenia; serotonin inhibitor; urinalysis

DESCRIPTION (Adapted from the Applicant?s Abstract): Objectives: This is one of four identical revised applications of a collaborative R01 proposal being conducted at the University of Washington, Seattle, WA, University of North Carolina (UNC), Chapel Hill, NC, Harvard Medical School, Boston, MA and Case Western University, Cleveland, Ohio. The study will examine the long-term effectiveness of three different antipsychotic medications in the treatment of early onset schizophrenia and schizoaffective disorder: risperidone (RIS), olanzapine (OLA), the molindone (MOL) over a one year period. Specific Aims: 1) To determine the efficacy of MOL, RIS, and OLA in reducing psychotic symptoms in youth with schizophrenia and related disorders; 2) To determine the ability to sustain treatment over one year with each of these agents; 3) To examine the effects of treatment on adaptive and neurocognitive functioning; and 4) To examine the safety and tolerability of these agents in the pediatric population, particularly potential effects on neuropyramidal symptoms and weight gain. Research Design: 168 youths (ages 8-19 years) with schizophrenia, schizophreniform disorder or schizoaffective disorder and active psychotic symptoms will be recruited across four sites. Subjects will be randomly assigned to double-blind treatment with one of the three study medications. Standard dosage schedules will be followed, with modifications allowed dependent on the clinical status of subjects. Antipsychotic agents will be cross-tapered over the first week of the study to prevent exacerbation of psychotic symptoms. Symptom ratings and neurocognitive testing will be performed at baseline and repeated at specific intervals. The acute phase of treatment will last 8 weeks. Subjects with clinically significant improvement and without intolerable side effects, will continue maintenance therapy for an additional 44 weeks. Tolerance of the study medications will be systematically monitored with assessments for extrapyramidal side effects and weight gain. Revision of treatment algorithms, reliability testing and data analysis will be coordinated between the four sites. Randomization, preparation of study medications, and overall management of the database will be centralized at UNC. Revisions: To address reviewers concerns, the revised proposal has added a fourth site (Harvard), revised the data management and analysis plan, and adjusted some of the primary outcome measures. Significance: There are very few controlled studies to inform clinical practice for the treatment of youth with psychotic disorders. This study will provide information about the comparative effectiveness of the most commonly used and representative antipsychotic drugs in youth with schizophrenia spectrum disorders.

描述(改编自申请人？S摘要)：目标：这是 协作R01提案的四个相同的修订申请是 在华盛顿大学，西雅图，华盛顿州，北方大学进行 北卡罗来纳州(北卡罗来纳州)，北卡罗来纳州教堂山，哈佛医学院，马萨诸塞州波士顿和凯斯 西部大学，俄亥俄州克利夫兰。这项研究将考察长期的 三种不同抗精神病药物治疗慢性阻塞性肺疾病的疗效 早发性精神分裂症和分裂情感障碍：利培酮(RIS)， 奥氮平(OLA)，吗林酮(MOL)，为期一年。 具体目标：1)确定MOL、RIS和OLA在减少 青少年精神分裂症及相关障碍的精神症状；2)至 确定每一项持续治疗一年以上的能力 药物；3)检查治疗对适应性和神经认知的影响 4)检查这些制剂的安全性和耐受性。 儿科人群，特别是对神经锥体的潜在影响 症状和体重增加。 研究设计：168例8~19岁青年精神分裂症患者， 分裂样障碍或分裂情感性障碍与主动性精神病 症状将在四个地点招募。受试者将随机 被分配用三种研究药物中的一种进行双盲治疗。 将遵循标准剂量计划，并允许修改 取决于受试者的临床状态。抗精神病药物将是 在研究的第一周交叉缩减以防止病情恶化 精神病症状。症状分级和神经认知测试将是 在基线上进行，并以特定的时间间隔重复。急性期 治疗将持续8周。临床上有显著改善的受试者 而且没有无法忍受的副作用，将继续维持治疗 额外的44周。研究药物的耐受性将是系统性的 监测锥体外系副作用和体重增加。 将修订治疗算法、可靠性测试和数据分析 在四个地点之间进行协调。随机化，研究准备 药物和数据库的整体管理将集中在北卡罗来纳大学。 修订：为了解决审查者的担忧，修订后的提案增加了一个 第四个站点(哈佛)，修订了数据管理和分析计划，以及 调整了一些主要成果衡量标准。 意义：很少有对照研究能为临床实践提供信息。 用于治疗患有精神障碍的青少年。这项研究将提供 关于最常用和最常用的 青年精神分裂症谱系中的代表性抗精神病药物 精神错乱。