Feighner J, Targum S D, Bennett M E, Roberts D L, Kensler T T, D'Amico M F, Hardy S A
Feighner Research Institute, San Diego, Calif 92121, USA.
J Clin Psychiatry. 1998 May;59(5):246-53. doi: 10.4088/jcp.v59n0508.
There are few published placebo-controlled clinical trials demonstrating the efficacy of the newer antidepressants in markedly or severely depressed hospitalized patients. This study demonstrates the efficacy of nefazodone compared with placebo in the treatment of patients hospitalized for major depression.
Nefazodone and placebo treatment were compared in a 6-week trial of 120 patients hospitalized for DSM-III-R diagnosed major depression (without psychosis) at 2 study centers. Efficacy was evaluated using standard psychiatric rating scales, and patients were monitored for safety.
Nefazodone treatment resulted in a significant reduction (p < .01) of the 17-item Hamilton Rating Scale for Depression (HAM-D-17) total score compared with placebo from the end of the first treatment week through the end of the study (-12.2 nefazodone vs. -7.7 placebo). At the end of the trial, significantly more nefazodone-treated patients (50%) than placebo-treated patients (29%) had responded, as indicated by their Clinical Global Impressions-Improvement score (p = .021) or by a > or = 50% reduction in their HAM-D-17 scores (p = .017). Significantly more patients treated with nefazodone (36%) than placebo-treated patients (14%) had a HAM-D-17 score < or = 10 at the end of treatment (p = .004). Significant treatment differences (p < .01) in favor of nefazodone were also seen in the Montgomery-Asberg Depression Rating Scale; the HAM-D retardation, anxiety, and sleep disturbance factors; and HAM-D item 1 (depressed mood). Patients with dysthymia in addition to major depression also showed significant improvement (p < .05) when treated with nefazodone, with significant differences in response rates seen as early as week 2 and through the end of the trial. The mean nefazodone dose was 491 mg/day at the end of week 2 and 503 mg/day at the end of treatment. Nefazodone was well tolerated, and the number of patients discontinuing owing to adverse events was small, with no significant safety issues noted in either treatment group. Fewer nefazodone-treated than placebo-treated patients discontinued owing to lack of efficacy.
Nefazodone was superior to placebo in the treatment of marked to severe major depression in patients requiring hospitalization. The clinical benefit of nefazodone was evident as early as the first week of treatment as judged by several measures of efficacy, with significant differences from placebo sustained throughout the trial.
很少有已发表的安慰剂对照临床试验证明新型抗抑郁药对明显抑郁或重度抑郁的住院患者有效。本研究证明了奈法唑酮与安慰剂相比在治疗因重度抑郁症住院患者中的疗效。
在2个研究中心对120例因DSM-III-R诊断为重度抑郁症（无精神病）而住院的患者进行了为期6周的试验，比较了奈法唑酮和安慰剂治疗。使用标准的精神病学评定量表评估疗效，并对患者进行安全性监测。
从治疗第一周结束到研究结束，与安慰剂相比，奈法唑酮治疗使17项汉密尔顿抑郁评定量表（HAM-D-17）总分显著降低（p <.01）（奈法唑酮组降低12.2分，安慰剂组降低7.7分）。在试验结束时，根据临床总体印象改善评分（p =.021）或HAM-D-17评分降低≥50%（p =.017），接受奈法唑酮治疗的有反应患者（50%）显著多于接受安慰剂治疗的患者（29%）。在治疗结束时，接受奈法唑酮治疗的患者（36%）HAM-D-17评分≤10分的显著多于接受安慰剂治疗的患者（14%）（p =.004）。在蒙哥马利-阿斯伯格抑郁评定量表、HAM-D迟缓、焦虑和睡眠障碍因子以及HAM-D第1项（抑郁情绪）方面也观察到有利于奈法唑酮的显著治疗差异（p <.01）。除重度抑郁症外还患有心境恶劣障碍的患者在接受奈法唑酮治疗时也显示出显著改善（p <.05），早在第2周直至试验结束，反应率均存在显著差异。在第2周结束时，奈法唑酮的平均剂量为491毫克/天，在治疗结束时为503毫克/天。奈法唑酮耐受性良好，因不良事件停药的患者数量较少，两个治疗组均未发现重大安全问题。因缺乏疗效而停药的接受奈法唑酮治疗的患者少于接受安慰剂治疗的患者。
在治疗需要住院的明显至重度重度抑郁症患者中，奈法唑酮优于安慰剂。从几种疗效测量指标判断，奈法唑酮的临床益处早在治疗第一周就很明显，在整个试验中与安慰剂的差异持续显著。
