TREATMENT OF EARLY AGE MANIA (TEAM)

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。研究目的TEAM研究的目的是评估三种不同药物对6 - 15.11岁躁狂症儿童和青少年的有效性。躁狂是一个术语，用来描述一种疾病，儿童可能会感觉很好或易怒，导致行为损害他们的功能。这三种研究药物是锂、丙戊酸盐和利培酮。研究描述团队研究分为三个部分。TEAM研究的第一部分是基线评估。第二部分为药物治疗评价（8-16周）。最后一部分是为期6个月的随访评估。因此，这项研究将需要长达10个月的时间来完成。研究药物是利培酮（商品名利培酮），锂（商品名Eskalith）和丙戊酸盐（商品名Depakote）。这些研究药物已被批准用于成人躁狂症患者，但尚未被FDA测试或批准用于儿童或青少年的躁狂症治疗。约翰霍普金斯大学将有约110名受试者参与。全美将有多达540名受试者参与这项研究

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. PURPOSE OF THE STUDY The purpose of the TEAM study is to evaluate the usefulness of three different medicines for children and teenagers ages 6 to 15.11 with mania. Mania is a term used to describe an illness in which children may feel so good or irritable leading to behavior that impairs their functioning. The three study medications are lithium, valproate, and risperidone. DESCRIPTION OF THE STUDY There are 3 parts to the TEAM study. The first part of the TEAM study is a baseline assessment. The second part is the medication treatment evaluation (8-16 weeks long). The last part is a 6-month follow-up assessment. Therefore, this study will take up to 10 months to complete. The study medications are risperidone (trade name Risperdal), lithium (trade name Eskalith), and valproate (trade name Depakote). These study medications are approved for use in adults with mania, but they have not yet been tested or approved by the FDA for treatment of mania in children or adolescents. There will be approximately 110 subjects participating here at Johns Hopkins. There will be up to 540 subjects participating in this study across the U.S.A.