Pharmacotherapy Relapse Prevention in BDD

描述(申请人提供)：我们建议在躯体变形障碍(BDD)中进行首个药物治疗复发预防研究。BDD是一种经常妄想的痴迷于想象的或轻微的外表缺陷，是一种令人痛苦、损害和相对常见的身体形象障碍。它与较高的功能损害率和明显较差的生活质量有关。似乎SRI对BDD常常是有效的，而且是有选择性的，而且许多BDD患者接受SRI。似乎大多数患者在某些时候会停止有效的SRI，因为另一种选择是终身治疗。然而，还没有进行过预防复发的研究。从临床和公共卫生的角度来看，这样的研究很重要，因为BDD似乎往往是慢性的，需要长期治疗。因此，至关重要的是要调查SRI停用后复发的风险，以及继续SRI治疗是否降低复发风险。 128名受试者将入选，首先用艾司匹兰公开治疗14周；然后58名艾司匹兰应答者将被随机分成使用艾司他普兰或安慰剂的双盲持续治疗6个月。我们的主要目的是比较急性艾司匹兰应答者的复发时间和复发率，然后将他们随机分为安慰剂组和继续使用艾司匹兰组。次要/探索性目标将探讨：1)继续服用艾司匹兰的受试者是否比服用安慰剂的受试者在次要结果指标(例如，生活质量)上表现得更好；2)继续服用艾司西普兰的受试者在持续阶段是否会进一步改善BDD症状；3)停止服用艾司匹兰后复发的预测因素；以及4)急性治疗反应。由于这项研究将提供一个独特的机会来研究BDD的遗传学基础，我们将探索BDD的遗传学基础以及选定的候选基因与治疗结果和副作用的关系。 总之，这项研究将是BDD中第一个预防复发的研究，也是BDD中第一个持续药物治疗的研究。它将提供关于SRI继续治疗与停止SRI的复发的关键信息，继续治疗是否防止复发，以及患者继续治疗是否进一步改善。它将探索以前没有研究过的关于BDD的药物遗传学的问题，这最终可能指导和加强药物治疗。这项研究将产生独特的和临床上重要的数据，并将填补关于这种相对常见、严重和研究不足的疾病的知识空白。

DESCRIPTION (provided by applicant): We propose to conduct the first pharmacotherapy relapse prevention study in body dysmorphic disorder (BDD). BDD, an often-delusional preoccupation with an imagined or slight defect in appearance, is a distressing, impairing, and relatively common body image disorder. It is associated with high rates of functional impairment and markedly poor quality of life. It appears that SRIs are often--and selectively-- efficacious for BDD and that many BDD patients receive SRIs. It also appears that most patients discontinue an efficacious SRI at some point, as the alternative is life-long treatment. However, no relapse prevention studies have been done. Such a study is important from a clinical and public health perspective, because BDD appears to often be chronic and require long-term treatment. It is therefore critically important to investigate the risk of relapse with SRI discontinuation, and whether continuation SRI treatment decreases relapse risk. 128 subjects will be enrolled and first treated openly for 14 weeks with escitalopram; 58 escitalopram responders will then be randomized to double-blind continuation treatment with escitalopram or placebo for 6 additional months. Our primary aim is to compare time to relapse and relapse rates in responders to acute escitalopram who are then randomized to placebo versus continuation treatment with escitalopram. Secondary/exploratory aims will explore 1) Whether subjects who receive continuation escitalopram perform better on secondary outcome measures (e.g., quality of life) than those on placebo; 2) Whether subjects taking continuation escitalopram have further improvement in BDD symptoms during the continuation phase; 3) Predictors of relapse after escitalopram discontinuation; and 4) Acute treatment response. Because this study will offer a unique opportunity to investigate the genetic basis of BDD, we will explore BDD's genetic basis and the relationship of selected candidate genes to treatment outcome and side effects. In summary, this study will be the first relapse prevention study in BDD and the first study of continuation pharmacotherapy in BDD. It will provide critically important information on relapse with continuation versus discontinuation of an SRI, whether continuation treatment protects against relapse, and whether patients further improve with continuation treatment. It will explore previously unstudied questions about BDD's pharmacogenetics, which may ultimately guide and enhance medication treatment. This study will yield unique and clinically important data, and will fill gaps in knowledge about this relatively common, severe, and understudied illness.