Efficacy of Bright Light Therapy Vs. Placebo for Bipolar Depression

描述(由申请人提供)：这是K23职业发展奖重新提交的申请1 K23 MH082114-01A1。我的职业发展目标是接受培训，学习：1)治疗试验研究设计、方法、统计分析和伦理行为；2)强光疗法治疗双相情感障碍(BD)的疗效；3)BD的生物节律和症状表现。在我的研究计划中，我提出了一项随机对照试验，以检验强光和非主动光治疗双相情感障碍的疗效。K23奖将为我提供技能、经验和试点数据，以建立独立的临床研究生涯。具体目标是将患者随机分为活动期和非活动期，并评估：1)抑郁症状水平的变化(SIGH-ADS；Williams等人，2003)，2)反应和缓解的比例；3)反应的持久性(复发时间、反应时间、缓解时间)。这些假设是：1)在第0至6周期间，主动光与非主动光相比，抑郁症会有更大的改善；2)被随机分为活动光与非主动光的患者中，有更大比例的患者会有反应(在基线SIGHADS上至少减少50%，持续2周或更长时间)和缓解(SIGHADS为8或更少，持续3周或更长时间)；3)对主动光与非活动光的应答者将有最持久的反应。意义重大。这是一项治疗试验，旨在探索一种创新的、新颖的躯体干预方法来治疗双相情感障碍。该提案解决了NIMH开发有效的BD抑郁症治疗方法的优先事项。我的K23应用程序建立在我发表的试验数据的基础上，该数据显示患有双相抑郁的女性对中午光疗法有强大的抗抑郁反应(Sit等人，2007年)。我将检查男性和女性的结果，并比较主动光和看似合理的安慰剂对照的疗效。设计。受试者被随机分成主动(7000勒克斯)和非主动(50勒克斯暗红色)两组。在急性期，轻剂量滴定至有效时间超过6周。试验结果为光剂量的时间和滴定提供了依据。受试者在第一周开始每天中午15分钟的活跃或昏暗的红光；剂量每周增加15分钟，到第4-6周每天最多60分钟。在持续阶段对应答者进行18周的跟踪，以评估反应的持久性。

DESCRIPTION (provided by applicant): This is a K23 Career Development Award resubmission of the application 1 K23 MH082114-01A1. My career development goals are to undergo training to learn: 1) treatment trials research design, methods, statistical analysis and ethical conduct; 2) the efficacy of bright light therapy for Bipolar Disorder (BD); 3) biological rhythms and symptom expression in BD. In my research plan, I propose a randomized controlled trial to examine the efficacy of bright vs. inactive light treatment for bipolar depression. The K23 Award will provide me skills, experience and pilot data to build an independent clinical research career. The specific aims are to randomize patients to active vs. inactive light and assess: 1) change in depressive symptom levels (SIGH-ADS; Williams et al, 2003), 2) the proportion that respond and remit; 3) durability of response (time to relapse, time to response, time to remission). The hypotheses are: 1) greater improvement in depression will occur with active vs. inactive light between Weeks 0 and 6; 2) a greater proportion of patients randomized to active vs. inactive light will respond (at least a 50% reduction on the baseline SIGHADS for 2 weeks or more) and remit (SIGHADS of 8 or less, for 3 weeks or more); 3) responders to active vs. inactive light will have the most enduring response. Significance. This is a treatment trial to explore an innovative, novel somatic intervention for bipolar illness. The proposal addresses the NIMH priority to develop effective depression treatments for BD. My K23 application builds upon my published pilot data of a robust antidepressant response to Midday Light Therapy in Women with Bipolar Depression (Sit et al, 2007). I will examine the outcomes in men and women and compare the efficacy of active light with a plausible placebo control. Design. Subjects are randomized to active (7000 lux) or inactive (50 lux dim red) light. The light dose is titrated to efficacy over 6 weeks in the acute phase. The pilot findings informed the timing and titration of the light dose. Subjects begin 15 minutes midday active or dim red light daily in Week 1; the dose advances by 15 minutes each week to a maximum 60 minutes daily by Weeks 4-6. Responders are followed for 18 weeks in the continuation phase to assess durability of response.