Leverich G S, Nolen W A, Rush A J, McElroy S L, Keck P E, Denicoff K D, Suppes T, Altshuler L L, Kupka R, Kramlinger K G, Post R M
Biological Psychiatry Branch, National Institute of Mental Health, Bethesda, MD 20892-1272, USA.
J Affect Disord. 2001 Dec;67(1-3):33-44. doi: 10.1016/s0165-0327(01)00430-x.
The NIMH-Stanley Foundation Bipolar Treatment Outcome Network, a multisite clinical trials network, has been established to address many of the neglected areas of research in bipolar illness. The Network was designed so that it would be able to conduct randomized clinical trials at several different levels of methodologic rigor (blinded and open-label) both in academic and community practice settings in order to better assess long-term efficacy of existing treatments and develop new ones. In this fashion, large numbers of representative patients with bipolar disorder have been enrolled with an additional focus of elucidating possible clinical and biological predictors of treatment response. The unique focus of the Network is its systematic longitudinal approach to illness so that patients can be assessed comprehensively over the long-term in sequential randomized clinical trials at critical clinical decision points where data on relative efficacy are inadequate. Bipolar I and bipolar II patients with a range of illness variants and comorbidities are included. Daily prospective ratings of severity of mania and depression and associated degree of functional impairment are completed on the NIMH-Life Chart Method and a modified Clinical Global Impressions Scale for Bipolar Illness (CGI-BP) is utilized. More detailed cross-sectional ratings for depression (Inventory of Depressive Symptomatology), mania (Young Mania Rating Scale), and psychosis (Positive and Negative Syndrome Scale) are additionally used at academic centers. This article describes the rationale for the Network, its guiding principles, methods, and study design to systematically assess the highly variable course of bipolar illness and its response to current and future treatments.
美国国立精神卫生研究所-斯坦利基金会双相情感障碍治疗结果网络是一个多中心临床试验网络，旨在解决双相情感障碍研究中许多被忽视的领域。该网络的设计初衷是能够在学术和社区实践环境中，在几个不同方法严谨程度的层面（双盲和开放标签）开展随机临床试验，以便更好地评估现有治疗方法的长期疗效并开发新的治疗方法。通过这种方式，大量具有代表性的双相情感障碍患者被纳入研究，另外还着重于阐明治疗反应可能的临床和生物学预测因素。该网络的独特之处在于其对疾病采用系统的纵向研究方法，这样在关键临床决策点（相对疗效数据不足）的连续随机临床试验中，能够对患者进行长期全面评估。纳入了患有一系列疾病变体和合并症的双相I型和双相II型患者。使用美国国立精神卫生研究所生活图表法完成对躁狂和抑郁严重程度以及相关功能损害程度的每日前瞻性评分，并采用改良的双相情感障碍临床总体印象量表（CGI-BP）。学术中心还额外使用了针对抑郁（抑郁症状量表）、躁狂（杨氏躁狂量表）和精神病（阳性和阴性症状量表）的更详细的横断面评分。本文描述了该网络的基本原理、指导原则、方法以及研究设计，以系统评估双相情感障碍高度可变的病程及其对当前和未来治疗的反应。
