Open-label tiagabine monotherapy for major depressive disorder with anxiety
Open-label tiagabine monotherapy for major depressive disorder with anxiety
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DOI：
10.4088/jcp.v67n0110
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发表时间：
2006-01-01
影响因子：
5.3
通讯作者：
Price, LH
中科院分区：
文献类型：
--
作者：
Carpenter, LL;Schecter, JM;Price, LH
目的：γ -氨基丁酸（GABA）在抑郁和焦虑的病理生理和治疗中发挥关键作用。替加滨（Tiagabine）是一种选择性GABA再摄取抑制剂（SGRI），可增强正常的GABA张力，在治疗抑郁症伴显著焦虑的疗效和安全性方面进行了评估。方法：在这项为期8周、单中心、开放标签的研究中，患有dsm - iv诊断的重度抑郁症和显著焦虑（即“焦虑性抑郁”）的成年人接受了替加滨单药治疗，开始剂量为4mg /天，然后滴定到最大剂量为20mg /天以获得最佳反应。定期评估症状、功能和不良事件。患者于2002年4月至2003年2月入院。结果：19名患者进入研究，15名患者符合意向治疗分析标准。其中，6人（40%）停止治疗，9人（60%）完成了8周的治疗方案。Tiagabine显著改善了抑郁症，正如汉密尔顿抑郁量表的平均+/- SD评分较基线（31.9 +/- 6）降低所示。1)到终点（17.0 +/- 12.4;p = 0.002）。分类有效率为47% （N = 7）。替加滨也显著改善焦虑（汉密尔顿焦虑量表基线评分为22.7 +/- 4.9，终点评分为12.5 +/- 8.8;p = 0.002）。SD最终日平均剂量为12.8 +/- 5.8 mg。最常见的不良反应是头晕、头痛和胃肠道不适/恶心。结论：这些结果提示SGRI替加滨治疗抑郁伴焦虑的潜力。需要大规模的安慰剂对照试验。
Objective: Gamma-aminobutyric acid (GABA) plays a key role in the pathophysiology and treatment of depression and anxiety. Tiagabine, a selective GABA reuptake inhibitor (SGRI) that enhances normal GABA tone, was evaluated for its efficacy and safety in the treatment of depression comorbid with significant anxiety.Method: In this 8-week, single-center, open-label study, adults with DSM-IV-diagnosed major depressive disorder and significant anxiety (i.e., "anxious depression") received tiagabine monotherapy, initiated at 4 mg/day and titrated for optimum response as tolerated to a maximum dose of 20 mg/day. Symptoms, function, and adverse events were assessed at regular intervals. Patients were entered from April 2002 to February 2003.Results: Nineteen patients entered the study and 15 met criteria for intent-to-treat analyses. Of those, 6 (40%) discontinued treatment and 9 (60%) completed the 8-week protocol. Tiagabine significantly improved depression, as shown by a reduction in mean +/- SD Hamilton Rating Scale for Depression scores from baseline (31.9 +/- 6. 1) to endpoint (17.0 +/- 12.4; p = .002). Categorical response rate was 47% (N = 7). Tiagabine also significantly improved anxiety (Hamilton Rating Scale for Anxiety baseline score of 22.7 +/- 4.9 vs. endpoint score of 12.5 +/- 8.8; p = .002). The mean SD final daily dose was 12.8 +/- 5.8 mg. The most commonly reported adverse events were dizziness, headache, and gastrointestinal upset/nausea.Conclusion: These results suggest the potential of the SGRI tiagabine in the treatment of depression with anxiety. Large, placebo-controlled trials are needed.