RELAPSE PREVENTION OF BIPOLAR TYPE-II DISORDER

描述：(改编自申请者摘要)双相U型(BP U)障碍 影响1.5%-2.5%的美国成年人口，并导致每年 医疗成本约为200亿美元。BP II疾病的特征是 严重抑郁发作(MDE)的高复发率，并与 相当高的发病率和死亡率。对有效治疗的认识 对于复发性MDE至关重要。不幸的是，相对较少 人们已经注意到了它的治疗。对“狂热开关”的担忧 BP U MDE的治疗阻碍了有效抗抑郁的发展 这种疾病的治疗和复发预防疗法。 我们最近公布的试验数据表明，氟西汀可能是一种 安全有效的单一疗法治疗BP、U、MDE和For BP II MDE的预防复发治疗。我们建议确定是否 氟西汀单一疗法是一种有效的治疗初发和 BP II MDE的预防复发治疗。我们还将确定是否 氟西汀单一治疗与躁狂症和 这些患者中有低躁狂性转换发作。 为了回答这些问题，将在4年内招募184名BP II患者 来自抑郁症研究单位(DRU)-该单位每年筛查400-500名新患者 年(其中约25%符合DSM-IV BP II或NOS标准 无序)。患者最初将接受氟西汀治疗10周，然后 缓解MDE的患者将采用随机双盲方法 时尚，接受以下预防复发治疗之一 年份：一)氟西汀单一疗法(20毫克/天)二)锂单一疗法 (600-1200毫克/天)III)锂(600-1200毫克/天)和 氟西汀(20毫克/天)，或iv)安慰剂。 我们相信，我们的研究有可能对 双相情感障碍的临床治疗现状 病人；一个极其重要的公共卫生问题。

DESCRIPTION: (Adapted from applicant's abstract) Bipolar Type U (BP U) disorder affects 1.5-2.5 percent of the U.S. adult population and results in annual healthcare costs of about $20 billion. BP II disorder is characterized by a high recurrence of major depressive episodes (MDE) and is associated with substantial morbidity and mortality. The recognition of effective treatments for recurrent MDE is of critical importance. Unfortunately, relatively little attention has been given to its treatment. Concern over a "manic switch" during treatments of BP U MDE have impeded the development of effective antidepressive treatments and relapse prevention therapies for this illness. We have recently published pilot data demonstrating that fluoxetine may be a safe and effective monotherapy for the treatment of BP U MDE and for relapse-prevention treatment of BP II MDE. We propose to determine whether fluoxetine monotherapy is an effective treatment for both the initial and relapse-prevention treatment of BP II MDE. We will also determine whether fluoxetine monotherapy is associated with a low incidence of manic and hypomanic switch episodes in these patients. To answer these questions, 184 BP II patients will be recruited over 4 years from the Depression Research Unit (DRU)-which screens 400-500 new patients per year (of which about 25 percent meet DSM-IV criteria for BP II or NOS disorder). Patients will be treated initially with fluoxetine for 10 weeks and patients who remit from their MDE will be randomized, in a double-blind fashion, to receive one of the following relapse-prevention treatments for one year: i) fluoxetine monotherapy (20mg/daily) ii) lithium monotherapy (600-1200mg/daily) iii) the combination of lithium (600-1200mg/daily) and fluoxetine (20mg/daily), or iv) placebo. We believe that our study has the potential to have a significant impact upon current clinical practice in the appropriate management of bipolar depressed patients; an extremely important public-health matter.