Department of Psychiatry, Bushehr University of Medical Sciences, Bushehr, Iran.
Prog Neuropsychopharmacol Biol Psychiatry. 2011 Jun 1;35(4):970-3. doi: 10.1016/j.pnpbp.2011.01.016. Epub 2011 Feb 1.
Despite evolution of new antidepressant treatment, clinicians still encounter challenges in the treatment of depressed patients. Looking for new medications that can potentiate the effects of current antidepressants seems to be necessary. Our objective is to survey the efficacy of topiramate augmentation in resistant major depressive disorder (MDD).
This augmentation trial was designed as an 8-week randomized, placebo-controlled, double-blind study. Fifty three patients with DSM-IV diagnosis of MDD who had failed to respond to at least 8 weeks of treatment with an adequate dose of one of the SSRIs (fluoxetine, citalopram or serteraline) were included in the study. Patients were randomized to receive a flexible dose of topiramate (100-200 mg/day) or placebo beside their current antidepressant medication for a period of eight weeks. Outcome measures were Hamilton Depression Scale (HAM-D) and Clinical Global Impression (CGI).
42 patients completed the study and there were 6 and 5 dropouts in topiramate and placebo groups, respectively. The topiramate group demonstrated significant improvement over the study period based on mean HAM-D score at week 8 compared to baseline (P = .000, Z = 3.699). Those receiving topiramate demonstrated to have a mean decrease of 32.0% in HAM-D score, compared to only 5.5% for those receiving placebo. Depressed mood, suicidality, insomnia (early, middle and late), agitation and anxiety symptoms were significantly improved in the topiramate group.
Our double-blind placebo-controlled study demonstrated that topiramate augmentation potentiate the efficacy of selective serotonin reuptake inhibitors (SSRIs) in treatment of resistant major depressive disorder. Of note is that our study is preliminary and larger double-blind studies are needed to confirm the results.
尽管新的抗抑郁治疗方法不断发展，但临床医生在治疗抑郁症患者时仍然面临挑战。寻找可以增强当前抗抑郁药效果的新药似乎是必要的。我们的目的是调查托吡酯增效治疗耐药性重度抑郁症（MDD）的疗效。
这项增效试验设计为 8 周随机、安慰剂对照、双盲研究。53 例 DSM-IV 诊断为 MDD 的患者，在接受至少 8 周的一种 SSRI（氟西汀、西酞普兰或舍曲林）充分剂量治疗后无反应，包括在这项研究中。患者被随机分为接受托吡酯（100-200mg/天）或安慰剂的弹性剂量，同时服用当前的抗抑郁药物，为期 8 周。主要疗效指标为汉密尔顿抑郁量表（HAM-D）和临床总体印象（CGI）。
42 例患者完成了研究，托吡酯组和安慰剂组分别有 6 例和 5 例脱落。与基线相比，托吡酯组在第 8 周时 HAM-D 评分的平均值在研究期间有显著改善（P=0.000，Z=3.699）。接受托吡酯治疗的患者 HAM-D 评分平均下降 32.0%，而接受安慰剂治疗的患者仅下降 5.5%。在托吡酯组，情绪低落、自杀意念、失眠（早期、中期和晚期）、烦躁不安和焦虑症状均有显著改善。
我们的双盲安慰剂对照研究表明，托吡酯增效可以增强选择性 5-羟色胺再摄取抑制剂（SSRIs）治疗耐药性重度抑郁症的疗效。值得注意的是，我们的研究是初步的，需要更大规模的双盲研究来证实这些结果。
