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首页> 外文期刊>European neuropsychopharmacology: the journal of the European College of Neuropsychopharmacology >Ziprasidone with adjunctive mood stabilizer in the maintenance treatment of bipolar I disorder: Long-term changes in weight and metabolic profiles
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Ziprasidone with adjunctive mood stabilizer in the maintenance treatment of bipolar I disorder: Long-term changes in weight and metabolic profiles

机译：Ziprasidone与辅助情绪稳定剂在双相性I障碍的维持治疗中：体重和代谢谱的长期变化

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This analysis was conducted to compare the effects of adjunctive ziprasidone or placebo on metabolic parameters among patients receiving maintenance treatment with lithium or valproate. We also tested whether metabolic syndrome (MetS) and other risk factors were associated with baseline characteristics and treatment response. In the stabilization phase (Phase 1), 584 bipolar I disorder (DSM-IV) patients received 2.5-4 months of open label ziprasidone (80-160 mg/d) plus lithium or valproic acid (ZIP + MS). Patients who achieved at least 8 weeks of clinical stability were subsequently randomized into Phase 2 to 6-months of double-blind treatment with ZIP + MS (n = 127) vs. placebo + MS (n = 113). At baseline of Phase 1, MetS was found in 111 participants (23%). Participants with MetS (vs. non-MetS participants) were more likely to be aged 40 years or older, had significantly more severe manic symptoms, higher abdominal obesity, and higher BMI. Increase in abdominal obesity was associated with lower manic symptom improvement (p < 0.05, as assessed by MRS change score) during Phase 1, while symptom improvement differed across racial groups. In the Phase 2 double-blind phase, the ZIP + MS group had similar weight and metabolic profiles compared to the placebo + MS group across visits. These results corroborate existing findings on ziprasidone which exhibits a neutral weight and metabolic profile in the treatment of schizophrenia and bipolar patients. Our findings suggest that MetS is highly prevalent in patients with bipolar disorder, may be associated with greater manic symptom severity, and may predict treatment outcomes.
机译：进行该分析以比较接受锂或丙戊酸盐维持治疗的患者中辅助吉拉西酮或安慰剂对代谢参数的影响。我们还测试了代谢综合征（MetS）和其他危险因素是否与基线特征和治疗反应相关。在稳定阶段（第1阶段），有584名双相I型障碍（DSM-IV）患者接受2.5-4个月的开放标签齐拉西酮（80-160 mg / d）加锂或丙戊酸（ZIP + MS）。获得至少8周临床稳定性的患者随后被随机分为2期至6个月的双盲治疗，分别为ZIP + MS（n = 127）与安慰剂+ MS（n = 113）。在第一阶段的基线，在111位参与者中发现了MetS（23％）。患有MetS的参与者（相对于非MetS参与者）更可能年龄在40岁或40岁以上，躁狂症状明显更严重，腹部肥胖和BMI更高。在第1阶段，腹部肥胖的增加与躁狂症状的改善相关（p <0.05，通过MRS变化评分评估），而种族差异在症状改善上有所不同。在第2阶段的双盲阶段，与安慰剂+ MS组相比，ZIP + MS组的体重和代谢谱相似。这些结果证实了齐拉西酮的现有发现，其在精神分裂症和双相情感障碍患者的治疗中表现出中性的体重和代谢特征。我们的发现表明，MetS在躁郁症患者中非常普遍，可能与躁狂​​症状的严重程度相关，并且可以预测治疗结果。

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