CLINICAL TRIAL: ADJUNCTIVE RISPERIDONE IN CLOZAPINE TREATED PATIENTS

临床试验：接受氯氮平治疗的患者辅助使用利培酮

• 批准号: 7951146
• 负责人: ROBERT W BUCHANAN
• 金额: $ 3.47万
• 依托单位: UNIVERSITY OF MARYLAND BALTIMORE
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-03-01 至 2010-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7951146
• 关键词: Address; Adverse effects; Antipsychotic Agents; Anxiety; Case Series; Client satisfaction; Clinical; Clinical Research; Clinical Trials; Clozapine; Computer Retrieval of Information on Scientific Projects Database; DSM-IV; Double-Blind Method; Evaluation; FDA approved; Funding; Generations; Grant; Hostility; Impaired cognition; Incidence; Inpatients; Institution; Maryland; Medical; Neurocognitive; Outpatients; Patients; Phase; Placebos; Prolactin; Quality of life; Randomized; Reporting; Research; Research Personnel; Resistance; Resources; Risperidone; Safety; Sampling; Schizoaffective Disorders; Schizophrenia; Source; Symptoms; United States National Institutes of Health; alternative treatment; clinical practice; control trial; depression; partial response; safety practice

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. Clozapine remains the only antipsychotic that has been FDA approved for treatment-resistant schizophrenia. Unfortunately, partial response to clozapine is common. In most controlled trials, forty to seventy per cent of treatment-resistant patients fail to adequately respond to clozapine treatment, and there are no proven viable treatment alternatives. The emerging clinical practice is to treat clozapine non-responders by adding a second antipsychotic to clozapine. In the State of Maryland, 15% of all clozapine-treated patients are treated with a second new generation antipsychotic and an additional 5-10% treated with an adjunctive conventional antipsychotic. There are a number of small case series reports but, to date, there is little empirical evidence to support the efficacy or safety of this practice. The proposed 16-week randomized double-blind comparison of adjunctive risperidone and placebo-risperidone in clozapine-treated patients with schizophrenia will address the following primary and secondary specific aims: Primary Study Objectives 1. To determine if adjunctive risperidone is superior to placebo for the treatment of persistent positive symptoms in clozapine-treated patients with schizophrenia. 2. To determine if adjunctive risperidone is superior to placebo for the treatment of cognitive impairments in clozapine-treated patients with schizophrenia. Secondary Study Objectives 1. To determine if adjunctive risperidone is superior to placebo for the treatment of persistent negative symptoms in clozapine-treated patients with schizophrenia. 2. To determine if adjunctive risperidone is associated with increased incidence of side effects as compared to placebo in clozapine-treated patients with schizophrenia. 3. To determine if adjunctive risperidone is superior to placebo for the treatment of anxiety/depression and hostility symptoms, clinical global improvement, quality of life, and patient satisfaction with treatment in clozapine-treated patients with schizophrenia. The proposed study is a randomized, double-blind comparison of adjunctive risperidone or placebo to clozapine. The sample will consist of 90 clinically stable inpatients and outpatients with DSM-IV schizophrenia or schizoaffective disorder. There will be a 4-week evaluation phase and a 16-week treatment phase. In the 4-week evaluation phase, patients will undergo baseline symptom, medical, safety, clozapine and prolactin levels, and neurocognitive assessments. In the 16-week treatment phase, patients will receive biweekly symptom, side effect, and vital sign assessments. At the end of the study (16 weeks), ripseridone, clozapine and prolactin levels will be obtained and neurocognitive assessments will be repeated.

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。 氯氮平仍然是唯一被 FDA 批准用于治疗难治性精神分裂症的抗精神病药物。不幸的是，对氯氮平的部分反应是常见的。在大多数对照试验中，百分之四十到七十的难治性患者对氯氮平治疗没有充分反应，并且没有经过验证的可行的治疗替代方案。新兴的临床实践是通过在氯氮平中添加第二种抗精神病药来治疗氯氮平无反应者。在马里兰州，所有接受氯氮平治疗的患者中有 15% 接受第二代新一代抗精神病药物治疗，另有 5-10% 接受辅助常规抗精神病药物治疗。有许多小型病例系列报告，但迄今为止，几乎没有经验证据支持这种做法的有效性或安全性。拟对接受氯氮平治疗的精神分裂症患者进行辅助利培酮和安慰剂利培酮的 16 周随机双盲比较，将解决以下主要和次要具体目标： 主要研究目标 1. 确定辅助利培酮在以下方面是否优于安慰剂：治疗接受氯氮平治疗的精神分裂症患者的持续阳性症状。 2. 确定辅助利培酮治疗接受氯氮平治疗的精神分裂症患者的认知障碍是否优于安慰剂。次要研究目标 1. 确定辅助利培酮对于治疗接受氯氮平治疗的精神分裂症患者的持续阴性症状是否优于安慰剂。 2. 确定在接受氯氮平治疗的精神分裂症患者中，与安慰剂相比，辅助利培酮是否会导致副作用发生率增加。 3. 确定辅助利培酮在治疗氯氮平治疗的精神分裂症患者的焦虑/抑郁和敌对症状、临床总体改善、生活质量和患者对治疗的满意度方面是否优于安慰剂。拟议的研究是辅助利培酮或安慰剂与氯氮平的随机、双盲比较。样本将由 90 名临床稳定的 DSM-IV 精神分裂症或分裂情感障碍住院患者和门诊患者组成。将有 4 周的评估阶段和 16 周的治疗阶段。在为期 4 周的评估阶段，患者将接受基线症状、医疗、安全性、氯氮平和催乳素水平以及神经认知评估。在 16 周的治疗阶段，患者将每两周接受一次症状、副作用和生命体征评估。研究结束时（16 周），将获得利普塞酮、氯氮平和催乳素水平，并重复神经认知评估。