ANTIDEPRESSANTS IN THE TREATMENT OF ANXIETY DISORDERS

描述(申请人摘要)：这项研究将涉及100名患者 患有恐慌症和广场恐惧症的人表现得很好和稳定 对丙咪嗪2.25 mg/kg/d统一治疗的反应。前100名 患者在16周和24周的评估中都表现出显著的反应 积极治疗将随机分配到双盲维持在 计划评估中使用相同剂量的丙咪嗪或安慰剂替代药物 每两个月一次，为期一年(0-12个月)。这将是 之后是为期一年的双盲延期阶段(12-24个月) 哪些安慰剂患者将继续处于同样的状态，而丙咪嗪 患者将接受继续丙咪嗪的第二次随机试验 维持或以安慰剂替代。最后，所有受试者， 补习者/复吸者以及从双打不同阶段退学的人 盲目治疗将遵循开放停药/不服药的范例 随机化后长达四年的时间。重复评估将包括 临床医生和患者对恐慌、恐怖、焦虑和 烦躁/抑郁，反应和复发的可操作性标准， 丙咪嗪及其代谢物的血药浓度和血药浓度评价 生活事件、个性和健康状况/幸福。的主要目的是 这项研究是为了评估具体由于以下原因而出现逆转/复发的程度 丙咪嗪停用2年，并对其特征 丙咪嗪的长期效应以及丙咪嗪的净效益 丙咪嗪维持在这种紊乱状态。此外，该项目将 提供有关急性和慢性疾病后复发率比较的系统数据 OPEN的维护处理和严谨的纵向数据 在维持不同时间的丙咪嗪后停药/复发。 这一结果应该对恐慌的长期管理具有重要意义 精神障碍患者，即维持药物治疗的程度 是否需要以及长期治疗的风险效益比 以及对生活质量和成本效益的影响 在这种混乱中维持/停止使用。

DESCRIPTION (Applicant's Abstract): The study will involve 100 patients with panic disorders with agoraphobia who have shown good and stable response to uniform treatment with imipramine 2.25 mg/kg/day. The first 100 patients to show marked response at both the 16 and 24 week assessments of active treatment will be randomly assigned to double blind maintenance on the same dose of imipramine or placebo substitution with planned assessments every two months for a duration of 1 year (months 0-12). This will be followed by a one year double blind extension phase (months 12-24) during which placebo patients will continue in the same condition while imipramine patients will imdergo a second randomization to continued imipramine maintenance or to placebo substition. Finally, all subjects, completers/relapsers as well as dropouts from the different stages of double blind treatment will be followed in an open discontinuation/no pill paradigm for up to four years post randomization. Repeated assessments will include clinician and patient rating of panic, phobia, anxiety and dysphoria/depression, operationalized criteria of response and relapse, plasma concentration of imipramine and metabolites and the assessment of life events, personality and health status/well being. The primary aim of the study is to assess the extent of reversals/relapse due specifically to withdrawal of imipramine over a 2 year period and to characterize imipramine's long term effects as well as the net beneficial effects of imipramine maintenance in this disorder. In addition, the project will provide systematic data on the comparative rate of relapse after acute and maintenance treatments and rigorous longitudinal data of open discontinuation/relapse after varying lengths of imipramine maintenance. The results should have significance for the long term management of panic disorder patients i.e., the extent to which maintenance pharmacotherapy is necessary and for how long, the risk benefit ration of long term treatment and compliance, and the quality of life and cost effectiveness implications of maintenance/discontinuation in this disorder.