Efficacy of Bright Light Therapy Vs. Placebo for Bipolar Depression

描述（由申请人提供）：这是K23职业发展奖申请1 K23 MH 082114 - 01 A1重新提交。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，统计分析和道德行为; 2）明亮的光疗法对双相情感障碍（BD）的疗效; 3）BD的生物节律和症状表达。在我的研究计划中，我提出了一个随机对照试验，以检查明亮与非活跃光治疗双相抑郁症的疗效。K23奖将为我提供技能，经验和试点数据，以建立一个独立的临床研究生涯。具体目的是将患者随机分配至活动光与非活动光，并评估：1）抑郁症状水平的变化（SIGH-ADS;威廉姆斯等人，2003），2）缓解和缓解的比例; 3）缓解的持久性（至复发时间、至缓解时间、至缓解时间）。假设是：1）在第0周和第6周之间，使用活性光与非活性光相比，抑郁症的改善更大; 2）随机分配到活性光与非活性光的患者比例更大，（基线SIGHADS至少减少50%，持续2周或更长时间）和缓解（8或更少的SIGHADS，持续3周或更长时间）; 3）对活跃光与不活跃光的响应者将具有最持久的响应。意义这是一项治疗试验，旨在探索双相情感障碍的创新性、新颖的躯体干预。该提案提出了NIMH优先发展有效的抑郁症治疗BD。我的K23应用程序建立在我发表的试验数据的基础上，这些数据表明，双相抑郁症女性对中午光疗法有强烈的抗抑郁反应（Sit et al，2007）。我将检查男性和女性的结果，并将主动光的功效与合理的安慰剂对照进行比较。设计受试者被随机分配到主动（7000勒克斯）或非主动（50勒克斯暗红色）光。在急性期，在6周内将光剂量滴定至有效。初步研究结果为光剂量的时间和滴定提供了信息。受试者在第1周开始每天中午活动或昏暗红光15分钟;剂量每周增加15分钟，到第4-6周每天最多增加60分钟。在持续阶段对应答者进行18周随访，以评估应答的持久性。

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.