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 MH082114-01A1的重新提交。我的职业发展目标是通过培训学习：1)治疗试验研究设计、方法、统计分析和道德行为；2)强光治疗双相情感障碍（BD）的疗效；3)双相障碍的生物节律和症状表达。在我的研究计划中，我提出了一项随机对照试验，研究强光治疗与无强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，以建立独立的临床研究事业。具体目的是将患者随机分配到积极和不积极的光照组，并评估：1)抑郁症状水平的变化（sighg - ads; Williams et al, 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）。假设是：1)在第0周到第6周之间，积极的光照比不积极的光照对抑郁症的改善更大；2)更大比例的随机分配到活跃光组和非活跃光组的患者会有反应（基线SIGHADS至少降低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）；对有光和无光的反应者会有最持久的反应。的意义。这是一个治疗试验，探索一种创新的，新的躯体干预双相情感障碍。该提案解决了NIMH优先开发有效的双相障碍抑郁症治疗方法的问题。我的K23申请建立在我发表的双相抑郁症女性午间光疗法抗抑郁反应的试验数据基础上（Sit等人，2007）。我将检查男性和女性的结果，并将主动光的效果与貌似合理的安慰剂对照进行比较。设计。受试者被随机分配到有光源（7000勒克斯）或无光源（50勒克斯暗红色）。在急性期，轻剂量滴定至6周有效。试验结果为光剂量的时间和滴定提供了信息。受试者在第一周每天中午进行15分钟的活动或微弱的红光；剂量每周增加15分钟，到第4-6周最多每天60分钟。应答者在持续期随访18周，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.