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。 这些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 充满了心理和社会压力这些机会包括干预的能力 适当、有效和一贯地开展工作，以便对个人和公众产生长期的深远影响。 健康疾病的后果。 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。的 主题是为治疗决策提供信息，这也需要涉及运营核心中的所有单位 作为方法核心中的单元。 我们已经选择了目前，作为例子，几个计划的研究，符合R-34的描述， 发展项目。这些项目，正如计划公告所建议的，旨在提供 初步数据，以指导未来的设计，更明确的调查。我们选择了一些例子 这说明了一系列相关的，但不同的问题，中心的调查人员将解决，以符合 我们的主题。我们还提供了一系列选定的计划试点研究，特别是涉及年轻人的研究。 investigators. 抗抑郁药在治疗假定的精神分裂症前驱症状中的潜在作用的研究将 提供受控数据，跟踪在开放的自然主义治疗中获得的令人兴奋的发现。另外这款 试验和它的结果将涉及到坚持的问题，因为我们已经发现，目标人群是更多 而不是抗精神病药物。它还涉及到不利影响的挑战，因为 与抗精神病药物相比，抗抑郁药物具有非常不同的风险特征。临床的作用 评估单元在确定适当的受试者方面至关重要，但也确保任何临床预测因素 与对一类药剂或另一类药剂的优先反应有关的信息被很好地捕获。同样， 生物标志物单元可以帮助告知生物和其他预测因子以及最终将 为治疗决策提供信息，并为基本机制提供线索。 物质诱发的精神障碍的治疗尚未得到足够的重视。做这样 个人需要抗精神病药物治疗以防止精神病复发？事实上，这些人 对精神病有高度的易感性/素质？中心的所有单位都进入 中心的项目和数据库有助于与以下方面进行重要的比较： 前驱症状和/或精神病不因表面上的物质使用而复杂化的患者 精神病体征和症状的沉淀。 类似地，年轻的双相情感障碍患者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抗精神病药物的潜在长期使用的重要决定以及影响该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因子在这种情况下的潜在作用不能过分强调。一个纵向数据库的可用性良好的特点双相情感障碍患者的精神障碍，使我们能够使用轨迹和症状为基础的聚类，除了传统的诊断方法。 在任何可能使用影响体重调节和代谢参数的药物的情况下，我们需要更好地了解预防和管理策略。我们选择了一个特别脆弱（在许多层面上）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，这些数据将在管理任何可能接受影响代谢药物治疗的患者方面具有价值。 最后，我们提出了一个项目，重点是方法的进步，涉及的发展， 适合早期疾病的功能电池。该电池涉及社会和角色功能的评估，利用能力与成就的措施来区分介导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.