ARIPIPRAZOLE FOR CLOZAPINE ASSOCIATED MEDICAL MORBIDITY

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。我们提出了一项为期8周的安慰剂对照试验，对70名氯氮平治疗的精神分裂症患者进行了为期4周的随访，以检查阿立哌唑对脂质和葡萄糖代谢以及身体成分的影响。我们还将执行一系列症状量表来检查联合治疗的临床相关性。本研究的结果应该有助于阐明阿立哌唑辅助治疗氯氮平患者的有效性，以及高脂血症与胰岛素抵抗和氯氮平治疗体重增加的关系。主要具体目标：1；通过对70名氯氮平治疗的精神分裂症患者进行为期8周的安慰剂对照试验，研究阿立哌唑降低空腹血脂（包括甘油三酯和总胆固醇）的功效。2. 观察阿立哌唑对减肥和降低BMI的疗效。3. 通过检测空腹胰岛素、稳态模型评估-胰岛素抵抗（HOMA-IR）和FSIVGTT的SI、SG的变化来检测阿立哌唑改善胰岛素抵抗和葡萄糖代谢的功效。4. 分析血脂、体重减轻和胰岛素抵抗改善的潜在预测因素，包括基线血脂、体重、年龄、性别、种族、活动水平和吸烟状况。

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. We propose a 8-week, placebo-controlled trial of the novel antipsychotic agent, aripiprazole, witha 4-week follow-up, for the adjunctive therapy in 70 clozapine treated schizophrenia subjects to examine aripiprazole's affect on lipid and glucose metabolism, as well as body composition. We will also perform a battery of symptoms scales to exam clinical correlates of combination therapy. The results of this study should help clarify the usefulness of adjunctive therapy with aripiprazole in clozapine-treated patients and the relationship of hyperlipidemia to insulin resistance and wight gain with clozapine treatment. Primary Specific Aims: 1. Examine the efficacy of aripiprazole for reducing fasting lipids, including triglycerides and total cholesterol, by conduction an 8-week placebo controlled trial of 15 mg aripiprazole in 70 clozapine-treated schizophrenia subjects. 2. Examine the ifficacy of aripiprazole for weight loss and BMI reduction. 3. Examine the efficacy of aripiprazole for improving insulin resistance and glucose metabolism measured by examining changes in fasting insulin, homeostatic model assessment-insulin resistance (HOMA-IR), and SI, SG from FSIVGTT. 4. Analyze potential predictors of response for improvements in lipids, weight loss, and insulin resistance, including baseline lipids, weight, age, gender, race, activity levels and smoking status.