ANTIDEPRESSANTS IN THE TREATMENT OF ANXIETY DISORDERS

描述（申请人摘要）：本研究将纳入100例患者 患有广场恐惧症的恐慌症患者， 对丙咪嗪2.25 mg/kg/天均匀给药的反应。 前100 患者在第16周和第24周评估时均显示出显著缓解， 将活性治疗随机分配至双盲维持治疗， 相同剂量的丙咪嗪或安慰剂替代计划评估 每两个月一次，为期一年（0-12个月）。 这将是 随后是为期一年的双盲扩展期（12-24个月）， 哪些安慰剂患者将继续在相同的条件下，而丙咪嗪 患者将接受第二次随机分组，继续使用丙咪嗪 维持或安慰剂替代。 最后，所有科目， 完成者/复发者以及从不同阶段的双重 将在开放停药/无药丸范例中进行盲态治疗 在随机化后长达四年。 重复评估将包括 临床医生和患者对恐慌、恐惧、焦虑和 烦躁不安/抑郁，反应和复发的操作标准， 丙咪嗪及其代谢产物的血浆浓度及 生活事件、个性和健康状况/福祉。 的主要目的 该研究旨在评估逆转/复发的程度，特别是由于 丙米嗪停药超过2年，并表征 丙咪嗪的长期影响以及净效益的 丙咪嗪维持治疗 此外，该项目将 提供关于急性和慢性乙型肝炎后复发率的比较数据， 维持治疗和严格的纵向数据开放 在不同的丙咪嗪维持时间后停药/复发。 研究结果对长期的恐慌管理具有重要意义 疾病患者即，维持药物治疗的程度 长期治疗的必要性和持续时间，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 在这种疾病中维持/中止。

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.