ANTIDEPRESSANTS IN ANXIETY DISORDERS--DISCONTINUATION/MAINTENANCE W/ IMIPRAMINE

焦虑症中的抗抑郁药——停药/用丙咪嗪维持治疗

• 批准号: 6115331
• 负责人: MATIG R MAVISSAKALIAN
• 金额: $ 1.92万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6115331
• 关键词: agoraphobia; behavioral /social science research tag; clinical research; drug screening /evaluation; drug withdrawal; human subject; human therapy evaluation; imipramine; longitudinal human study; mental disorder chemotherapy; panic disorder; placebos; relapse /recurrence; tricyclic antidepressant

The main objectives of the study are a) to assess the extent of worsening/relapse upon discontinuation of imipramine and to test the hypothesis that maintenance on the drug protects from such reversal in a total experimental sample of 100 subjects with panic disorder and agoraphobia who have shown good and stable response to 6 months of systematic open treatment prior to randomization to the 12 month prospective placebo controlled discontinuation/maintenance phase of the study; b) An evaluation of late relapse/reversals achieved by extending the observation period of the double-blind placebo substitution condition to 24 months; c) A controlled assessment of relapse within the 12 month period following discontinuation of 1 year maintenance treatment d) A follow-up for 3 to 4 years from initial randomization of study completers and relapsers who are retreated as well as subjects who drop out from various stages of the double-blind protocol in order to gather systematic longitudinal and clinically relevant data specifically as they relate to relapse after varying lengths of imipramine maintenance treatment. The methods employed include an initial open treatment phase for 6 months. Patients who show a good response to treatment are randomized to double-blind treatment to either placebo or continuation of medication for 12 months. A second randomization then occurs; the placebo group continues on placebo and the medication group is randomized again to either placebo or continuation of the medication. We have enrolled 44 subjects and six have reached the 2nd randomization stage.

这项研究的主要目标是：a)评估停用丙咪嗪后恶化/复发的程度，并在100名患有惊恐障碍和广场恐惧症的实验样本中检验维持药物可防止这种逆转的假设，这些受试者在随机分成12个月的预期安慰剂控制的停药/维持阶段之前，对6个月的系统开放治疗表现出良好和稳定的反应；b)评估通过将双盲安慰剂替代条件的观察期延长至24个月而实现的晚期复发/逆转；C)在停止一年维持治疗后的12个月内对复发进行受控评估d)对研究完成者和复发者以及退出双盲方案不同阶段的受试者进行为期3至4年的初步随机化，以收集系统的纵向和临床相关数据，特别是与不同长度的丙咪嗪维持治疗后复发有关的数据。所采用的方法包括为期6个月的初始开放治疗阶段。对治疗反应良好的患者被随机分成双盲治疗组，服用安慰剂或继续服药12个月。然后进行第二次随机化；安慰剂组继续服用安慰剂，药物组再次随机接受安慰剂或继续服药。我们已经招募了44名受试者，其中6名已经进入第二随机阶段。