Pharmacotherapy Prevention in Body Dysmorphic Disorder

身体畸形障碍的药物治疗预防

• 批准号: 7066618
• 负责人: Sabine Wilhelm
• 金额: $ 29.91万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-05-16 至 2010-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7066618
• 关键词: behavioral /social science research tag; blood tests; body image; citalopram; clinical research; clinical trials; delusions; depression; drug screening /evaluation; family genetics; human subject; human therapy evaluation; interview; longitudinal human study; mental disorder chemotherapy; molecular genetics; personality disorders; pharmacogenetics; psychological stressor; quality of life; questionnaires; relapse /recurrence; self concept; serotonin inhibitor; social adjustment

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 SSRI 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 SSRI discontinuation, and whether continuation SSRI 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.

描述（由申请人提供）：我们建议在人体畸形疾病（BDD）中进行首次药物治疗预防研究。 BDD是一种经常放弃的群体，外观上有想象中的或轻微的缺陷，是一种令人痛苦的，损害和相对常见的身体形象障碍。它与高功能障碍率高，生活质量明显差。看来SRI通常（有选择地）对BDD有效，许多BDD患者接受SRIS。似乎大多数患者在某个时候停止有效的SSRI，因为另一种方法是终身治疗。但是，尚未进行预防复发研究。从临床和公共卫生的角度来看，这项研究很重要，因为BDD似乎通常是慢性的，需要长期治疗。因此，研究中断SSRI的复发风险以及继续进行SSRI治疗是否会降低复发风险，这一点至关重要。 将招收128名受试者，并首先公开治疗依他普兰（Escitalopram）。 58苏联抗毒性反应者将随机分配给依源瓜或安慰剂的双盲延续治疗，持续6个月。我们的主要目的是比较急性依他普兰的反应者复发和复发率的时间，急性依他普兰随后将安慰剂与依他张兰州继续进行。次要/探索目的将探索1）接受依他普兰的持续性依然瓜的受试者在次要结果指标（例如生活质量）上的表现是否比安慰剂上的受试者更好； 2）在延续阶段，接受依他普兰的受试者是否会进一步改善BDD症状； 3）依源富兰终止后复发的预测因素； 4）急性治疗反应。因为这项研究将为研究BDD的遗传基础提供独特的机会，所以我们将探讨BDD的遗传基础以及选定的候选基因与治疗结果和副作用的关系。 总而言之，这项研究将是BDD中的首次预防复发研究，也是BDD中连续药物疗法的首次研究。它将通过持续与停用SRI的复发至关重要的信息，是否持续治疗可以防止复发，以及患者是否通过继续治疗进一步改善。它将探讨有关BDD药物遗传学的先前未研究的问题，该问题最终可能指导和增强药物治疗。这项研究将产生独特且临床上重要的数据，并将填补有关这种相对常见，严重和研究疾病的知识的空白。