In this randomized, double-blind, placebo-controlled clinical trial, we assessed the efficacy and safety of pentoxifylline combination therapy with sertraline in treatment of major depressive disorder (MDD). A total of 56 patients with MDD were assigned into two parallel groups to receive sertraline (100 mg/day) plus placebo or sertraline (100 mg/day) plus pentoxifylline (400 mg three times daily) for six weeks. Patients were evaluated with the Hamilton rating scale for depression (HAM-D) at baseline and weeks 2, 4 and 6. The sertraline plus pentoxifylline group demonstrated greater improvement in HAM-D scores from baseline to all three study time points (P = 0.013, 0.007 and 0.016 for week 2, 4 and 6, respectively). Response to treatment rate was also significantly higher in the sertraline plus pentoxifylline group compared to the sertraline plus placebo group at week 4 [57.1 vs. 21.4%, P = 0.013] and the study endpoint [96.4 vs. 57.1%, P = 0.001]. However, the remission rate, time to remission and time to treatment response did not show any significant difference between trial groups. Our findings support the efficacy and safety of pentoxifylline combination therapy in patients with MDD.

中文翻译：

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己酮可可碱联合治疗重度抑郁症的疗效和安全性：一项随机、双盲、安慰剂对照的临床试验。

在这项随机、双盲、安慰剂对照的临床试验中，我们评估了己酮可可碱与舍曲林联合治疗重度抑郁症 (MDD) 的疗效和安全性。共有 56 名 MDD 患者被分配到两个平行组，分别接受舍曲林（100 毫克/天）加安慰剂或舍曲林（100 毫克/天）加己酮可可碱（400 毫克，每天 3 次）治疗六周。在基线和第 2、4 和 6 周时使用汉密尔顿抑郁量表 (HAM-D) 评估患者。舍曲林加己酮可可碱组显示从基线到所有三个研究时间点的 HAM-D 评分有更大的改善 (P = 0.013 ，第 2、4 和 6 周分别为 0.007 和 0.016）。在第 4 周时，舍曲林加己酮可可碱组对治疗的反应率也显着高于舍曲林加安慰剂组 [57.1 对 21.4%，P = 0.013] 和研究终点 [96.4 对 57.1%，P = 0.001] . 然而，缓解率、缓解时间和治疗反应时间在试验组之间没有显示出任何显着差异。我们的研究结果支持己酮可可碱联合治疗对 MDD 患者的疗效和安全性。