The use of pindolol with fluoxetine in the treatment of major depression: Final results from a double-blind, placebo-controlled trial
The use of pindolol with fluoxetine in the treatment of major depression: Final results from a double-blind, placebo-controlled trial
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DOI：
10.1016/s0006-3223(98)00383-7
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发表时间：
1999-05-01
影响因子：
10.6
通讯作者：
Charney, DS
中科院分区：
文献类型：
--
作者：
Berman, RM;Anand, A;Charney, DS
背景：初步报告表明，吲哚洛尔和5-羟色胺再摄取抑制剂的联合应用可显著加速临床反应；然而，最近该小组在一组服用氟西汀和吲哚洛尔的抑郁症患者中报道了来自随机、双盲、对照试验的相互矛盾的证据。在此，我们报告了扩大样本量的最终结果。方法：有严重抑郁发作的非药物门诊患者被随机分为两种治疗条件之一：氟西汀(每天20毫克)与吲哚洛尔(每天7.5-10毫克)或氟西汀(每天20毫克)与安慰剂。6周后，对服用氟西汀和安慰剂的患者进行3周以上的单盲随访。结果：86名患者按方案至少完成了1周或1周以上，其中45名患者被随机分为吲哚洛尔组和41名安慰剂组。服药2周后，吲哚洛尔组(16%)和安慰剂组(19%)的部分缓解率(即抑郁评分较基线至少下降50%)具有可比性。到研究结束时，服用吲哚洛尔组的67%和服用安慰剂组的80%的患者至少暂时获得了部分缓解。与对照组相比，服用平多洛尔的患者血压和脉搏显著降低。两组在流失率、起效时间和副作用方面没有总体差异。结论：这些扩展结果与我们之前发表的研究结果一致，也不支持吲哚洛尔在以慢性和复发性抑郁症为主的患者群体中加速氟西汀临床反应的有效性。(C)1999年生物精神病学学会。
Background: Preliminary reports have suggested that concomitant institution of pindolol and serotonin reuptake inhibitors robustly hastens clinical response; however, contradictory evidence from a randomized double-blind, controlled trial was recently reported by this group in a population of depressed patients who were prescribed fluxoetine and pindolol. Herein, we report final results from an extended sample size.Methods: Drug-free outpatients with a major depressive episode were randomized in a double-blind manner to one of two treatment conditions: fluoxetine (20 mg daily) with pindolol (7.5 to 10 mg daily) or fluoxetine (20 mg daily) with placebo. After 6 weeks, patients were followed for 3 more,weeks in a single-blind manner, on fluoxetine and placebo pindolol.Results: Eighty-six patients completed at least 1 or more weeks on protocol, with 45 and 41 patients randomized to the pindolol and placebo groups respectively. After 2 weeks on protocol, partial remission (i.e., at least 50% decrease in depression rating scores from baseline) rates for pindolol (16%) and placebo (19%) groups were comparable. By the study's end, a partial remission was achieved at least transiently for 67% of the pindolol group and 80% of the placebo group. Pindolol treatment was associated with statistically significant reduction in blood pressure and pulse as compared to the control group. The two groups did not have overall differences in rates of attrition, time to response, and side effects.Conclusions: In accord with our previously published findings, these extended results do nor support the efficacy of pindolol in hastening clinical response to fluoxetine in a patient population with predominantly chronic and recurrent depression. (C) 1999 Society of Biological Psychiatry.