Pharmacotherapy Relapse Prevention in BDD

描述（由申请人提供）：我们建议在身体畸形障碍（BDD）中进行第一项药物治疗复发预防研究。BDD是一种经常出现的妄想性专注于想象或轻微的外观缺陷，是一种令人痛苦的，损害性的和相对常见的身体形象障碍。它与功能障碍的高发生率和明显较差的生活质量有关。看来SRI对BDD通常是有效的，并且是选择性的，许多BDD患者接受SRI。似乎大多数患者在某个时间点停止有效的SRI，因为替代方案是终身治疗。然而，尚未进行复发预防研究。从临床和公共卫生的角度来看，这样的研究是重要的，因为BDD似乎往往是慢性的，需要长期治疗。因此，研究SRI停药后复发的风险以及继续SRI治疗是否会降低复发风险至关重要。 128例受试者将入组，首先接受艾司西酞普兰开放治疗14周; 58例艾司西酞普兰应答者将随机接受艾司西酞普兰或安慰剂的双盲持续治疗，再持续6个月。我们的主要目的是比较急性艾司西酞普兰应答者的复发时间和复发率，然后将其随机分配至安慰剂组和继续艾司西酞普兰治疗组。次要/探索性目的将探索1）继续接受艾司西酞普兰的受试者在次要结局指标（例如，生活质量）; 2）继续服用艾司西酞普兰的受试者在继续阶段是否进一步改善BDD症状; 3）停用艾司西酞普兰后复发的预测因素; 4）急性治疗反应。因为这项研究将提供一个独特的机会来研究BDD的遗传基础，我们将探索BDD的遗传基础和所选候选基因与治疗结果和副作用的关系。 总之，本研究将是第一项BDD复发预防研究，也是第一项BDD持续药物治疗研究。它将提供关于SRI继续与停止的复发，继续治疗是否防止复发以及患者是否通过继续治疗进一步改善的至关重要的信息。它将探索以前未研究的问题，BDD的药物遗传学，这可能最终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，并将填补有关这种相对常见，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.