Gelenberg Alan J, Trivedi Madhukar H, Rush A John, Thase Michael E, Howland Robert, Klein Daniel N, Kornstein Susan G, Dunner David L, Markowitz John C, Hirschfeld Robert M A, Keitner Gabor I, Zajecka John, Kocsis James H, Russell James M, Miller Ivan, Manber Rachel, Arnow Bruce, Rothbaum Barbara, Munsaka Melvin, Banks Phillip, Borian Frances E, Keller Martin B
Department of Psychiatry, Health Sciences Center, University of Arizona, PO Box 245002, Tucson, AZ 85724-5002, USA.
Biol Psychiatry. 2003 Oct 15;54(8):806-17. doi: 10.1016/s0006-3223(02)01971-6.
Maintenance treatment to prevent recurrences is recommended for chronic forms of major depressive disorder (MDD), but few studies have examined maintenance efficacy of antidepressants with chronic MDD. This randomized, placebo-controlled study of the efficacy and safety of nefazodone in preventing recurrence was conducted for patients with chronic MDD.
A total of 165 outpatients with chronic, nonpsychotic MDD, MDD plus dysthymic disorder ("double-depression"), or recurrent MDD with incomplete inter-episode recovery, who achieved and maintained a clinical response during acute and continuation treatment with either nefazodone alone or nefazodone combined with psychotherapy, were randomized to 52 weeks of double-blind nefazodone (maximum dose 600 mg/day) or placebo. The occurrence of major depressive episodes during maintenance treatment was assessed with the 24-item Hamilton Rating Scale for Depression, a DSM-IV MDD checklist, and a blinded review of symptom exacerbations by a consensus committee of research clinicians.
Application of a competing-risk model that estimated the conditional probability of recurrence among those patients remaining on active therapy revealed a significant (p =.043) difference between nefazodone (n = 76) and placebo (n = 74) when the latter part of the 1-year maintenance period was emphasized. At the end of 1 year, the conditional probability of recurrence was 30.3% for nefazodone-treated patients, compared with 47.5% for placebo-treated patients. Prior concomitant psychotherapy during acute/continuation treatment, although enhancing the initial response, was not associated with lower recurrence rates. Discontinuations due to adverse events were relatively low for both nefazodone (5.3%) and placebo (4.8%). Somnolence was significantly greater among the patients taking active medication (15.4%), compared with placebo (4.6%).
Nefazodone is well-tolerated and is an effective maintenance therapy for chronic forms of MDD.
对于重度抑郁症（MDD）的慢性形式，推荐进行维持治疗以预防复发，但很少有研究探讨抗抑郁药对慢性MDD的维持疗效。本研究针对慢性MDD患者开展了一项关于奈法唑酮预防复发的疗效和安全性的随机、安慰剂对照研究。
共有165例慢性、非精神病性MDD、MDD合并恶劣心境障碍（“双重抑郁”）或发作间期恢复不完全的复发性MDD门诊患者，这些患者在单独使用奈法唑酮或奈法唑酮联合心理治疗的急性和持续治疗期间实现并维持了临床反应，将其随机分为接受52周双盲奈法唑酮（最大剂量600mg/天）或安慰剂治疗。使用24项汉密尔顿抑郁评定量表、DSM-IV MDD清单以及由研究临床医生共识委员会对症状加重情况进行的盲法评估来评定维持治疗期间重度抑郁发作的发生情况）。
应用竞争风险模型估计继续接受积极治疗的患者中复发的条件概率，当强调1年维持期的后半段时，奈法唑酮组（n = 76）和安慰剂组（n = 74）之间存在显著差异（p = 0.043）。在1年末，接受奈法唑酮治疗的患者复发的条件概率为30.3%，而接受安慰剂治疗的患者为47.5%。急性/持续治疗期间先前的联合心理治疗虽然增强了初始反应，但与较低的复发率无关。奈法唑酮组（5.3%）和安慰剂组（4.8%）因不良事件停药的比例相对较低。与安慰剂组（4.6%）相比，服用活性药物的患者嗜睡情况明显更严重（15.4%）。
奈法唑酮耐受性良好，是慢性形式MDD的有效维持治疗药物。
