Research Center for Psychiatry and Behavioral Sciences, Shiraz University of Medical Sciences, School of Medicine, Shiraz, Iran; Department of Psychiatry, Shiraz University of Medical Sciences, School of Medicine, Shiraz, Iran.
Research Center for Psychiatry and Behavioral Sciences, Shiraz University of Medical Sciences, School of Medicine, Shiraz, Iran; Department of Psychiatry, Shiraz University of Medical Sciences, School of Medicine, Shiraz, Iran.
Schizophr Res. 2013 Jun;147(1):110-115. doi: 10.1016/j.schres.2013.03.021. Epub 2013 Apr 11.
Many patients with schizophrenia suffer from metabolic symptoms and weight gain in which predispose them to obesity, diabetes, and cardiovascular problems. This trial examines the efficacy and safety of zonisamide on weight and body mass index in patients with schizophrenia being administered with atypical antipsychotics.
In this 10-week, double blind randomized placebo controlled clinical trial, forty one patients with schizophrenia diagnosed according to DSM-IV-TR criteria who were taking a stable dose of atypical antipsychotic are allocated into one of the two groups of zonisamide or placebo group. Weight, body mass index, waist circumference, and adverse effects were assessed.
The two groups were not statistically different regarding baseline characteristics on age, gender, education, diagnosis, weight, body mass index, daily cigarette smoking, and the duration of illness. After 10 weeks, the patients in the placebo group had significantly gained weight, while the patients in the zonisamide group lost weight (mean=1.9, SD=2.2 versus mean=-1.1 kg, SD=1.4). The changes of body mass index in the two groups were significantly different. Body mass index decreased in the zonisamide group (mean=-0.3, SD=0.4) while it increased in the placebo group (mean=2.2, SD=6.9). There was a significance difference between the two groups regarding waist circumference at the end of trial (P<0.0001), too. The waist increased in the placebo group while it decreased in the zonisamide group (mean=1.1, SD=1.7 versus mean=-0.7, SD=1.2, respectively), as well. The frequencies of adverse effects were not significantly different between the two groups and zonisamide was tolerated well.
Zonisamide as an adjuvant treatment is tolerated well and markedly affect on the weight loss of patients with schizophrenia being treated with atypical antipsychotics.
许多精神分裂症患者存在代谢症状和体重增加，这使他们容易肥胖、患糖尿病和心血管疾病。本试验研究了佐尼沙胺对正在服用非典型抗精神病药物的精神分裂症患者的体重和体重指数的疗效和安全性。
在这项为期 10 周的双盲随机安慰剂对照临床试验中，41 名根据 DSM-IV-TR 标准诊断为精神分裂症的患者正在服用稳定剂量的非典型抗精神病药物，将其分配到佐尼沙胺或安慰剂组之一。评估体重、体重指数、腰围和不良反应。
两组患者在年龄、性别、教育程度、诊断、体重、体重指数、每日吸烟量和病程等基线特征方面无统计学差异。10 周后，安慰剂组患者体重明显增加，而佐尼沙胺组患者体重减轻（平均=1.9，SD=2.2 与平均=-1.1kg，SD=1.4）。两组患者的体重指数变化有显著差异。佐尼沙胺组体重指数下降（平均=-0.3，SD=0.4），而安慰剂组体重指数上升（平均=2.2，SD=6.9）。两组患者在试验结束时的腰围也有显著差异（P<0.0001）。安慰剂组腰围增加，而佐尼沙胺组腰围减少（平均=1.1，SD=1.7 与平均=-0.7，SD=1.2）。两组不良反应发生率无显著差异，佐尼沙胺耐受性良好。
佐尼沙胺作为辅助治疗药物，耐受性良好，对接受非典型抗精神病药物治疗的精神分裂症患者的体重减轻有显著影响。
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