COURSE OF TREATMENT RESISTANT DEPRESSION

难治性抑郁症的病程

• 批准号: 6220119
• 负责人: ANDREW A NIERENBERG
• 金额: $ 0.06万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 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/6220119
• 关键词: MAO inhibitors; antidepressants; clinical research; clinical trial phase I; combination chemotherapy; drug screening /evaluation; human subject; human therapy evaluation; lithium; major depression; mental disorder chemotherapy; nortriptyline

This study will assess sequential treatments for patients with treatment-resistant depression: first, a trial of nortriptyline; second, the antidepressant efficacy of the addition of lithium to the failed trial of nortiptyline; third, tranylcypromine with or without lithium for those patients who do not respond to lithium augmentation of nortriptyline. Dr. Nierenberg has extensive experience in conducting clinical trials in depression and has done the only study to date to assess the longitudinal course of depressed patietns who were treated with lithium augmentation. Patients will receive a six-week open-trial of nortriptyline. Nonresponders will then be eligible for a six-week double-blind placebo-controlled study of lithium added to the failed trial of nortriptyline. Patients who receive placebo will be eligible to have lithium added for six weeks. Patients who fail lithium augmentation of nortriptyline will be eligible to receive either tranylcypromine plus placebo or tranylcypromine plus lithium for another eight weeks. Subjects will be between the ages of 18 and 60, hve a major depression without psychosis with a 17-item Hamilton Depression Scale Score of >18, and have failed between 1 and 5 adequate antidepressant trials for the current episode. Patietns will be excluded if they have failed a trial of either nortripyline or lithium, or if they have been intolerant of either nortriptyline or lithium, are pregnant, have any allergies or medical conditions that preclude the use of either nortriptyline or lithium, have active drug or alcohol abuse within the past year, or are acutely suicidal.

这项研究将评估难治性抑郁症患者的顺序治疗：第一，去甲替林的试验；第二，在去甲替林失败的试验中加入锂的抗抑郁效果；第三，对去甲替林的锂强化治疗无效的患者，三羟环丙胺加锂或不加锂。尼伦伯格博士在进行抑郁症的临床试验方面拥有丰富的经验，他完成了迄今为止唯一一项评估接受锂强化治疗的抑郁症患者纵向病程的研究。患者将接受去甲替林为期六周的开放试验。无效者将有资格参加为期六周的双盲安慰剂对照研究，研究对象是在去甲替林试验失败的基础上加入锂的研究。接受安慰剂治疗的患者将有资格获得为期六周的锂添加。去甲替林锂强化治疗失败的患者将有资格再接受三羟环丙胺加安慰剂或三羟环丙胺加锂治疗八周。受试者年龄在18岁到60岁之间，有严重的抑郁症，没有精神病，汉密尔顿抑郁量表的17个条目得分为18分，并且在当前事件中有1到5次足够的抗抑郁药物试验失败。如果患者未能通过去甲替林或锂的试验，或者如果他们对去甲替林或锂不耐受，怀孕，有任何过敏或医疗条件阻止使用去甲替林或锂，在过去一年内有活跃的药物或酒精滥用，或有严重自杀倾向，患者将被排除在外。