CBT Augmentation of Paroxetine for Social Anxiety

描述（由申请人提供）：社交焦虑症是一种普遍的、慢性的、致残的疾病。帕罗西汀因其对这种疾病的急性疗效已获得FDA批准，但其长期治疗仍不确定。尽管有证据表明大多数接受急性帕罗西汀治疗的患者仍然表现出明显的残留症状，但实际上没有关于下一步治疗的数据。此外，尽管有证据表明在这种情况下复发率很高，但也没有关于在停止用药后尽量减少复发的方法的数据。认知行为疗法（CBT）是增加帕罗西汀反应和减少停药后复发的一个很好的选择，因为它已被证明是一种有效的治疗方法，并且通常比单独用药更少复发。尽管认知行为疗法被发现对抑郁症和恐慌症有帮助，但在社交焦虑症方面还没有类似的研究。这个应用程序将检查CBT的能力，以增加急性帕罗西汀反应和减少帕罗西汀停药后复发的社交焦虑症。它还将检查残留症状和残疾的程度，以及单独使用帕罗西汀或添加CBT后的缓解率和生活质量的改善。急性反应和治疗停止后复发的预测因素也将被探讨。为了达到这些目的，250名患者将接受12周的帕罗西汀开放治疗。显示出至少一些益处的患者将被随机分配到有或没有CBT的持续帕罗西汀组，再持续16周。然后，所有的治疗将逐渐减少，患者将被随访24周。总的来说，本研究应该提供关于帕罗西汀对社交焦虑症患者治疗的增强，减少复发的有效方法，以及谁可能从帕罗西汀治疗中受益或停药后复发的重要信息。它还将增加对社会心理和药物治疗方法以及患者对治疗总反应的心理和生物因素的相互作用的理解。

DESCRIPTION (provided by applicant): Social anxiety disorder is a prevalent, chronic and disabling condition. Paroxetine has received FDA approval on the basis of its acute efficacy for this disorder, but much about longer-term management remains uncertain. There are virtually no data regarding next steps in treatment despite evidence that most patients who receive acute paroxetine therapy still exhibit significant residual symptoms. Furthermore, there are also no data regarding methods for minimizing relapse when medication is discontinued despite evidence that relapse rates in such circumstances are high. Cognitive-behavioral therapy (CBT) is a good candidate for augmenting paroxetine response and reducing relapse after medication discontinuation as it has been shown to be an effective treatment in its own right and often associated with lesser relapse than medication alone. Although CBT has been found to be useful in these circumstances for depression and panic disorder, there have been no similar studies in social anxiety disorder. This application will examine the ability of CBT to augment acute paroxetine response and reduce relapse following paroxetine discontinuation in social anxiety disorder. It will also examine the degree of residual symptoms and disability as well as rates of remission and improvements in quality of life in response to paroxetine alone or with the addition of CBT. Predictors of acute response and relapse after treatment is discontinued will also be explored. To achieve these ends, two hundred fifty patients will receive 12 weeks of open treatment with paroxetine. Patients showing at least some benefit will be randomized to continued paroxetine with or without CBT for 16 additional weeks. All treatment will then be tapered and patients will be followed for 24 additional weeks. Overall, this study should provide important information about the augmentation of paroxetine treatment for patients with social anxiety disorder, effective methods for reducing relapse, and who may benefit from paroxetine treatment or relapse when medication is withdrawn. It will also increase understanding of the interplay of psychosocial and pharmacological treatment methods and psychological and biological factors in patients' total response to treatment.