Trials Operation Unit (OPERATIONS CORE)

早期精神病和假定的前驱状态代表着巨大的挑战和机遇。 挑战包括年龄范围内的诊断不确定性，这对成熟和个性化至关重要。 并且充满了心理和社会压力。这些机会包括干预的能力 适当、有效和始终如一地对个人和公众产生长期深刻的影响 健康疾病后果。 在我们的主要研究核心中，我们正在/将在这方面进行一系列广泛的研究。这个 主题是告知治疗决定，这需要业务核心中的所有单位也参与进来 作为方法核心中的单元。 作为例子，我们选择了几项符合R-34类分子描述的计划研究 发展项目。根据计划公告的建议，这些项目旨在提供 初步数据指导今后的设计，更加确定的调查。我们精选了一些例子 其中说明了中心调查人员将根据以下要求解决的相关但不同的问题范围 我们的主题。我们还提供了一系列精选的计划试点研究，特别是那些涉及年轻人的研究 调查人员。 抗抑郁药在精神分裂症先兆Will治疗中的潜在作用研究 提供对照数据，跟进在开放自然疗法中获得的令人兴奋的发现。此外，这一点 试验及其结果将与依从性问题有关，因为我们发现目标人群更多 接受抗抑郁药而不是抗精神病药。它还涉及到不利影响挑战，因为 与抗精神病药物相比，抗抑郁药有非常不同的风险概况。临床医生的角色 评估单位在确定适当的受试者和确保任何临床预测指标方面都至关重要 与对一类或另一类代理的优先响应相关联的信息被很好地捕获。与此类似， 生物标志物单元可以帮助告知生物和其他预测者以及中介变量，最终 告知治疗决定并提供基本机制的线索(S)。 物质所致精神障碍的治疗还没有得到足够的重视。做这样的事 个人需要抗精神病药物治疗以防止精神病复发吗？这些人真的是个人吗 对精神障碍有更高的易感性/素质？中心的所有单位都进入了 在解决这一问题方面发挥作用，中心项目和数据库促进了与 前驱症状和/或精神病并不因表面上的药物使用而复杂化的患者 精神病症状和体征的沉淀。 同样，在患有双相情感障碍的年轻人中出现精神病症状也提出了一些问题 诊断和诊断稳定性，以及关于可能长期使用抗精神病药物的重要决定，以及影响这一人群的相关依从性和不良反应问题。 同样，生物标志物和临床预测指标在这方面的潜在作用怎么强调都不为过。对特征明确的精神病患者的纵向数据库的可用性使我们除了传统的诊断方法外，还可以使用基于轨迹和症状的聚类。 在任何可能影响体重调节和代谢参数的药物使用的情况下，我们都需要更好地了解预防和管理策略。我们选择了一个(在许多层面上)特别脆弱的人群(即早发性精神分裂症)来研究降低风险的策略。 该项目还利用了该中心所有单位的资源和指导，这些数据对于管理任何可能接受新陈代谢药物治疗的患者都将是有价值的。 最后，我们提出了一个关注方法进步的项目，该项目涉及到一个 适用于早期疾病的功能电池。这个组合包括对社会和角色功能的评估，利用能力和成就的测量来区分调解早期患者功能障碍的关键方面。

Early phase psychotic illness and putative prodromal states represent enormous challenges and opportunities. The challenges include diagnostic uncertainty in an age range which is critical to maturation and individuation and fraught with psychological and social stresses. The opportunities include the ability to intervene appropriately, effectively and consistently in order to have a profound impact on long-term individual and public health disease consequences. In our Principal Research Core we are/will be conducting an extensive series of studies in this context. The theme is to inform treatment decisions and this requires involving all of the units in the Operations Core as well as the units in the Methods Core. We have selected to present, as examples, several planned studies which fit the description of R-34-like development projects. These projects, as suggested by the Program Announcement, are intended to provide preliminary data to guide the design of future, more definitive investigations. We have selected examples which illustrate the range of related, but distinct, issues that Center investigators will address in keeping with our theme. We have also provided a selected array of planned pilot studies, particulariy those involving young investigators. The study of the potential role of antidepressants in the treatment of the putative schizophrenia prodrome will provide controlled data following up exciting findings obtained in open naturalistic treatment. In addition, this trial and it's results will relate to the adherence issue in that we have found the target population to be more accepting of antidepressants than of antipsychotics. It also relates to the adverse effects challenges, because antidepressants have very different risk profiles compared to antipsychotics. The role of the clinical assessment unit is critical in both identifying appropriate subjects, but also ensuring that any clinical predictors associated with preferential response to one class of agents or another are well-captured. Similariy, the biomarker unit can help to inform biological and other predictors and mediating variables which will ultimately inform treatment decisions and provide clues to basic mechanism(s). The treatment of substance-induced psychotic disorder has not received adequate attention. Do such individuals require antipsychotic treatment to prevent recurrence of psychosis? Are these in fact, individuals with a heightened vulnerability/diathesis toward psychotic disorders? All of the units in the Center come into play in addressing this question and the Center projects and data base facilitate important comparisons with patients whose prodromal symptoms and/or psychoses are not complicated by seeming substance use precipitation of psychotic signs and symptoms. Similariy, the presence of psychotic symptoms in young individuals with bipolar disorder raises questions about diagnosis and diagnostic stability as well as important decisions about the potential long-term use of antipsychotic drugs and the related adherence and adverse effects issues affecting this population. Again the potential role of biomarkers and clinical predictors in this context cannot be overemphasized. The availability of a longitudinal data base on well-characterized bipolar patients with psychotic disorders enables us to use trajectory and symptom based clustering in addition to traditional diagnostic approaches. In any situation where drugs which affect weight regulation and metabolic parameter are potentially used, we need to have a better understanding of preventive and management strategies. We have chosen a particulariy vulnerable (on many levels) population (i.e. early onset schizophrenia) to study a strategy or risk reduction. This project also draws on the resources and guidance of all of the Center's Units, and the data will be valuable in managing any patients who might be treated with drugs affecting metabolism. Finally, we propose a project focusing on method advancement that involves the development of an appropriate functional battery for eariy phase illness. This battery involves the assessment of both social and role functioning, utilizing measures of competence versus achievement to differentiate key aspects mediating functional disability in eariy phase patients.