Nickel Cerstin, Lahmann Claas, Tritt Karin, Muehlbacher Moritz, Kaplan Patrick, Kettler Christian, Krawczyk Jakub, Loew Thomas H, Rother Wolfhardt K, Nickel Marius K
Clinic for Psychosomatic Medicine, Inntalklinik, 84359 Simbach am Inn, Germany.
J Affect Disord. 2005 Aug;87(2-3):243-52. doi: 10.1016/j.jad.2005.04.003.
Depression is associated with increased aggression and diminished ability and quality of life. The goal of this study was to compare the efficacy of topiramate in influencing depressive symptoms, aggression, ability, and health related quality of life in depressive women.
We conducted a randomized, double-blind, placebo-controlled 10-week study of topiramate in 64 female subjects from the general population who met criteria for recurrent major depressive disorder. Primary outcome measures were changes on the Hamilton Depression Rating Scale (HDRS), the State-Trait Anger Expression Inventory (STAXI), the Test of Attention (d2), and the SF-36 Health Survey (SF-36).
According to the intent-to-treat principle, a significant difference on the HDRS (P=0.02), all scales of STAXI (all P<0.001), Total efficiency of d2 (P<0.001), and on most scales of SF-36 (P between 0.15 and <0.001) were observed in the topiramate-treated subjects comprised the placebo group. The reduction in expression of anger correlated significantly with changes on the HDRS, and several scales of d2 and SF-36. Additional weight loss, which was significantly more pronounced in the topiramate group than in those treated with a placebo, was ascertained (difference in weight loss between the two groups: 4.2 kg, P<0.001). All the patients tolerated topiramate relatively well.
Only moderately ill women were included.
Topiramate appears to be an effective agent in the reduction of depressive symptoms and anger and in the improvement of ability and health-related quality of life in depressive women. Additional weight loss can be expected.
抑郁症与攻击性增加、能力下降及生活质量降低有关。本研究的目的是比较托吡酯对抑郁女性的抑郁症状、攻击性、能力及健康相关生活质量的影响效果。
我们对64名符合复发性重度抑郁症标准的普通女性受试者进行了一项为期10周的随机、双盲、安慰剂对照的托吡酯研究。主要结局指标为汉密尔顿抑郁量表(HDRS)、状态-特质愤怒表达量表(STAXI)、注意力测试(d2)及SF-36健康调查量表(SF-36)的变化。
根据意向性分析原则,在接受托吡酯治疗的受试者与安慰剂组之间,观察到HDRS有显著差异(P = 0.02),STAXI的所有量表(所有P < 0.001)、d2的总效率(P < 0.001)以及SF-36的大多数量表(P在0.15至<0.001之间)均有显著差异。愤怒表达的降低与HDRS、d2及SF-36的几个量表的变化显著相关。确定了托吡酯组的额外体重减轻明显比安慰剂治疗组更显著(两组体重减轻差异:4.2 kg,P < 0.001)。所有患者对托吡酯的耐受性相对良好。
仅纳入了病情中等的女性。
托吡酯似乎是一种有效药物,可减轻抑郁女性的抑郁症状和愤怒,改善其能力及健康相关生活质量。预计会有额外的体重减轻。