Topiramate add-on treatment in schizophrenia: a randomised, double-blind, placebo-controlled clinical trial
Topiramate add-on treatment in schizophrenia: a randomised, double-blind, placebo-controlled clinical trial
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DOI：
10.1177/0269881108089816
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发表时间：
2009-03-01
影响因子：
4.1
通讯作者：
Talaei, M.
中科院分区：
文献类型：
--
作者：
Afshar, H.;Roohafza, H.;Talaei, M.
谷氨酸拮抗剂，如托吡酯，是基于精神分裂症的谷氨酸假说提出的，因为它的性质鼓励它作为一种治疗精神分裂症的药物的探索和可能的发展。一项随机、双盲、安慰剂对照的临床试验对18至45岁的精神分裂症患者进行了研究。基线信息包括生命体征、身高、体重、吸烟状况、人口统计学特征、（过去）精神病史、用药史和药物相关不良反应。患者被随机分配到托吡酯组或安慰剂组。采用阳性和阴性证候量表（PANSS）评估治疗效果，并于第0天（基线）、第28天和第56天记录治疗耐受性。托吡酯组基线、28和56天的PANSS值（95%置信区间）分别为96.87（85.37 ~ 108.37）、85.68（74.67 ~ 96.70）和76.87 (66.06 ~ 87.69)；安慰剂组为101.87（90.37-113.37）、100.31（89.29-111.32）、100.56（89.74-111.37）。重复测量分析的一般线性模型显示，与安慰剂组相比，托吡酯显著降低了PANSS值。在所有三个亚量表（阴性、阳性和精神病理体征）中都发现了类似的显著下降模式。托吡酯治疗组的临床反应（PANSS降低20%以上）明显高于对照组（50% vs 12.5%）。考虑到托吡酯对阴性症状和控制抗精神病药相关体重增加的影响，它可能是控制精神分裂症症状的有效药物。
Glutamate antagonists such as topiramate have been proposed based on the glutamate hypothesis of schizophrenia because its properties encourage its exploration and possible development as a medication for the treatment of schizophrenia. A randomised, double-blind, placebo-controlled clinical trial was performed on 18- to 45-year-old patients with schizophrenia. Baseline information including vital signs, height, weight, smoking status, demographic characteristics, (past) psychiatric history, medication history and medication-related adverse effects were collected. Patients were randomly assigned to a topiramate or placebo group. Efficacy of medication was measured by administering Positive and Negative Syndrome Scale (PANSS), and tolerability of treatment was recorded on day 0 (baseline), day 28 and day 56. PANSS values (95% confidence interval) at baseline, day 28 and day 56 in the topiramate group were 96.87 (85.37-108.37), 85.68 (74.67-96.70) and 76.87 (66.06-87.69), respectively; compared with 101.87 (90.37-113.37), 100.31 (89.29-111.32) and 100.56 (89.74-111.37) in the placebo group. General linear model for repeated measures analysis showed that topiramate has lowered PANSS values significantly compared with the placebo group. Similar significant decline patterns were found in all three subscales (negative, positive and psychopathology sign). Clinical response (more than 20% reduction in PANSS) was significantly higher in topiramate-treated subjects than controls (50% vs 12.5%). Topiramate can be an effective medication in controlling schizophrenic symptoms, considering its effect on negative symptoms and controlling antipsychotic-associated weight gain.