ANTIDEPRESSANTS IN THE TREATMENT OF ANXIETY DISORDERS

抗抑郁药治疗焦虑症

• 批准号: 3381989
• 负责人: MATIG R MAVISSAKALIAN
• 金额: $ 22.55万
• 依托单位: OHIO STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1986
• 资助国家: 美国
• 起止时间: 1986-09-01 至 1995-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3381989
• 关键词: antidepressants; anxiety disorders; behavior test; clinical anxiety; clinical depression; drug withdrawal; human subject; human therapy evaluation; imipramine; longitudinal human study; mental disorder chemotherapy; panic disorder; phobias; placebos; psychopharmacology; relapse /recurrence

The study consists of a double-blind, randomized, placebo-controlled prospective 12 month maintenance on imipramine or placebo, followed by a 6 month discontinuation and drug/pill free phase in 80 panic disorder with agoraphobia patients who have shown good and stable response to open treatment with imipramine at the fixed weight adjusted dosage of 2.25 mg/kg/day in the preceding 6 months of active treatment. The first 80 patients to show marked response at both the 4 month and 6 month assessments of active treatment will randomly be assigned to maintenance on the same dose of imipramine or placebo with planned assessments every 2 months. Assessments will include demographic and clinical information and a comprehensive battery of clinician and patient ratings of the most salient major symptom domains of the disorder: panic, phobia and dysphoria/depression as well as operationalized and clinically relevant criteria of response and relapse. The specific aims of the proposed study are: 1) to assess the extent of reversals/relapse due specifically to withdrawal of imipramine over a 1 year period, 2) to assess the extent to which maintained improvement and response are specifically due to continued exposure to the pharmacological effects of pharmacotherapy, 3) to characterize imipramine's longterm effects by studying the relationship between symptomatology and plasma drug levels over the maintenance course. Thus, the study will assess the net beneficial effects of imipramine in maintaining the original improvement/response induced by the drug and will provide pilot data on the comparative rates of relapse after acute and maintenance treatment phases. In view of the chronic and fluctuating course of this disorder and the increasing numbers of patients who are effectively treated with imipramine or similar drugs, the results of the study should have important implications for the longterm management of panic disorder with agoraphobia patients, i.e., relapse and duration to relapse upon discontinuation of imipramine, risk-benefit ratio of maintenance treatment and compliance. In addition, the study extends our programmatic research in the characterization of imipramine's shorterm effects in this disorder.

本研究包括一项双盲、随机、安慰剂对照研究。 丙咪嗪或安慰剂的前瞻性12个月维持治疗，随后是6个月的 在80例惊恐障碍患者中， 广场恐怖症患者对开放式治疗的反应良好且稳定， 丙咪嗪治疗，固定体重调整剂量为2.25 mg/kg/天。 前80 患者在4个月和6个月时均显示出显著反应 活性治疗的评估将随机分配至维持治疗， 相同剂量的丙咪嗪或安慰剂，计划每2 个月 评估将包括人口统计学和临床信息， 一个全面的电池的临床医生和病人的评级最 突出的主要症状领域的障碍：恐慌，恐惧症和 烦躁不安/抑郁以及操作和临床相关 缓解和复发的标准。 拟议研究的具体目标 1）评估逆转/复发的程度，具体原因是 停用丙咪嗪超过1年，2）评估程度， 持续改善和响应的原因是 暴露于药物治疗的药理作用，3） 通过研究丙咪嗪的长期作用与 维持治疗期间的血液学和血浆药物水平之间的关系。 因此，该研究将评估丙咪嗪在治疗中的净有益作用。 维持药物诱导的原始改善/反应，并将 提供关于急性和慢性感染后复发率的比较试验数据， 维持治疗阶段。 鉴于长期和波动的 这种疾病的过程和越来越多的患者谁是 用丙咪嗪或类似药物有效治疗， 这项研究对长期管理具有重要意义。 惊恐障碍伴广场恐怖症患者，即，复发和持续时间 丙咪嗪停药后复发，风险-获益比 维持治疗和依从性。 此外，该研究扩展了我们的 丙咪嗪短期疗效的程序性研究 在这种混乱的影响。