Relapse Prevention Study: Steering and Implementation

预防复发研究：指导和实施

• 批准号: 7536432
• 负责人: Nina R Schooler
• 金额: $ 16.02万
• 依托单位: FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-02-01 至 2010-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7536432
• 关键词: Address; Adherence; Adverse effects; Antipsychotic Agents; Attention; Biometry; California; Case Report Form; Clinical Research; Clinical Trials; Clinical Trials Data Monitoring Committees; Clinical assessments; Collaborations; Consent; Data Analyses; Data Quality; Disease; Doctor of Medicine; Doctor of Philosophy; Double-Blind Method; Drug Formulations; Drug Industry; Effectiveness; Ensure; Face; Future; Generations; Grant; Hospitalization; Human Resources; Individual; Injectable; Injection of therapeutic agent; Judgment; Lead; Leadership; Los Angeles; Manuals; Marketing; Masks; Measurement; Mentors; Methodology; Methods; Microspheres; Modeling; Monitor; Moods; Oral; Outcome; Outpatients; Participant; Patient Care; Patient Participation; Patients; Pharmaceutical Preparations; Population Study; Positioning Attribute; Principal Investigator; Procedures; Protocols documentation; Psychopathology; Quality of life; Randomized; Recording of previous events; Relapse; Reporting; Research; Research Design; Research Personnel; Risk; Risperidone; Schedule; Schizoaffective Disorders; Schizophrenia; Services; Site; Site Visit; Substance abuse problem; Talents; Testing; Time; Training; United States; Universities; Visit; base; career development; data management; design; disorder later incidence prevention; experience; improved; medication compliance; meetings; member; non-compliance; open label; patient population; prevent; primary outcome; symposium

DESCRIPTION (provided by applicant): Over time adherence to oral medication erodes in many schizophrenia patients, increasing relapse risk. Improving term medication adherence prevents relapse and may improve other outcomes. Until now, the only long-acting psychotic medications were high potency, first-generation antipsychotics that carry a significant side effect burden are perceived as the treatment of choice only for patients with documented histories of non-compliance and relapse second-generation anti-psychotic, risperidone, will soon be available in a long-acting injectable formulation, risperidone microspheres. We propose an eight-site randomized, open label trial to compare its effectiveness to second-generation oral anti-psychotics. Over the 5 year study period, 304 in- and out-patients will be randomized, treated for up 30 months and assessed by both remotely located, and local independent masked assessors in a number of critical domain. Details of the study rationale and methodology are provided in the individual site applications. The coordinating team will be led by John M. Kane, MD and includes Stephen R, Marder, MD and Nina R. Schooler, PhD, a group with extensive expertise in directing long-term clinical trials of schizophrenia. Each has led major studies of the older depot anti-psychotics, and they have collaborated successfully on multi-site studies. They will direct the fine-tuning of study design, oversee and coordinate recruitment, staff training, monitoring of rater-reliability and data quality at all sites. They will oversee data management, statistical analysis and reporting of results. A DSMB will be supported by grant. The coordination model includes conference calls to insure that specific groups, e.g. project coordinators, interact regularly. Face to face meetings of research teams will also be employed. A detailed study manual and site visits by coordinating team members will enhance cross-site consistency in protocol implementation. The site P.I.s represent talent and expertise, but none of them bas ever led a study of this scope. Participation in this study under the guidance the coordinating team will position them to lead future multi-site research in a field that sorely needs experienced investigators. Generalizability will be enhanced by the randomized but open-label design, which mirrors actual treatment more closely than does a double-blind design. The study is timely; the broadest population for study will be available when risperidone microspheres first comes to the market. Once clinicians have begun to prescribe this medication, patients who have received it will be excluded from the study and generalizability will decline. The study addresses questions that are unlikely to be studied by pharmaceutical industry sponsors and will generate unique information regarding long-term treatment options for schizophrenia.

描述（由申请人提供）：随着时间的流逝，许多精神分裂症患者的口服药物侵蚀，增加了复发风险。 改善术语药物依从性可防止复发，并可能改善其他结果。到目前为止，唯一长期的精神病性药物是高效力，携带重大副作用负担的第一代抗精神病药仅被视为仅对于有记录的不合规和第二代抗精神病病史的患者的选择治疗，而Risperidone则很快就可以在长时间的可注射式配方剂中，可在长期表演中获得。 我们提出了一项八个位点随机开放标签试验，以将其有效性与第二代口服抗精神药物进行比较。 在5年的研究期内，将有304名住院患者进行随机分配，对30个月进行治疗，并在许多关键领域的远程评估和当地独立的蒙版评估者进行评估。在各个站点应用中提供了研究理由和方法论的详细信息。协调团队将由医学博士John M. Kane领导，其中包括Stephen R，Marder，MD和Nina R. Schooler博士，该小组在指导精神分裂症的长期临床试验方面具有广泛的专业知识。 每个人都领导了旧仓库抗心理药物的主要研究，并且他们成功地在多站点研究上进行了合作。他们将指导研究设计，监督和协调招聘，员工培训，监视所有站点的评估者权利和数据质量的监视。他们将监督数据管理，统计分析和结果报告。 DSMB将得到Grant的支持。协调模型包括电话会议，以确保特定群体，例如项目协调员定期进行交互。研究团队的面对面会议也将被雇用。 协调团队成员的详细研究手册和现场访问将增强协议实施中的跨站点一致性。该网站P.I.S代表人才和专业知识，但他们都没有任何人对此范围进行研究。参与这项研究的指导，协调团队将把他们定位为在非常需要经验丰富的研究人员的领域中领导未来的多站点研究。 随机但开放标签的设计将增强推广性，该设计比双盲设计更接近实际处理。 这项研究是及时的；当利培酮微球首先进入市场时，最广泛的研究人群将提供。一旦临床医生开始开处方这种药物，接受该药物的患者将被排除在研究之外，并且可推广性会下降。 该研究解决了制药行业赞助商不太可能研究的问题，并将产生有关精神分裂症长期治疗选择的独特信息。