Ziprasidone plus a mood stabilizer in subjects with patients with manic or mixed episode of bipolar disorders

Abstract

Abstract: AIM: To explore efficacy and safety of ziprasidone combining lithium carbonate or valproate in the treatment of patients with manic and mixed episode of bipolar disorders. METHODS: The 68 patients meeting criteria of manic episode or mixed episode of bipolar disorder in CCMD-3 were randomly divided into experiment group( combination of ziprasidone and lithium carbonate or valproate) and control group( single using of lithium carbonate or valproate) and observed for 6 weeks.The Yong Manic Rating Scale(YMRS) and treatment emergent symptom scale(TESS)were individually used for the assessment of efficacy and safety.RESULTS: The score of YMRS was decreased significantly in the both groups after treatment(F=9.05,P<0.01;F=6.10,P<0.01).And the score of YMRS at 1st weekend in experiment group was significantly higher than that in control group,and this difference sustained for 6 weeks.The cure rate in experiment group was higher than that in control group after treating for 6 weeks.The scores of YMRS in experiment group were 21.4±8.4,14.6±5.5,8.9±3.3,6.5±3.4,respectively at 1 weekend, 2 weekend and 3 weekend;and the scores of YMRS in control group were 23.9±7.2,20.9±8.1,17.8±7.8,12.8±8.9,respectively.There was significant difference between the experiment group and control group(P<0.01). The changes of decreasing score of symptoms were in experiment group 6.1±3.5,12.9±4.8,20.1±5.3,21.4±5.5; and the changes of decreasing score of symptoms in control group were 2.1±3.0,6.8±4.5,11.5±5.6,14.4±5.3,respectively. There was significant difference between the experiment group and control group(P<0.01). The effective rate and cure rate in experiment group was significantly higher than that in control group(68.5% vs 48.5%, χ²=4.47,P<0.05;54.3%vs 18.2%, χ²=9.52,P<0.01). Both groups have not serious side effects. There were no difference in dropout rate due to less efficacy and side effects. CONCLUSION: The effects of ziprasidone combination with lithium carbonate or valproate in the treatment of manic episode and mixed episode of bipolar disorder is better than that of single lithium carbonate or valproate.

Key words: Ziprasidone, Mood stabilizers, Manic episode, Mixed episode, Bipolar disorder

CLC Number:

R749

REN Zhi-bin, CHEN Zheng-xin, JIN Wei-dong, MA Yong-chun, CHEN Jiong, XING Bao-ping, WANG He-qiu. Ziprasidone plus a mood stabilizer in subjects with patients with manic or mixed episode of bipolar disorders[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2013, 18(1): 78-82.

References

[1] 李华芳,马崔,王刚,等.奎硫平与锂盐治疗双相障碍急性躁狂的随机双盲对照多中心研究[J].中华精神科杂志,2008,41(2):85-88.
[2] 任志斌,童振华,金卫东,等.齐拉西酮与利培酮治疗精神分裂症对照研究的Meta分析[J]. 精神医学杂志,2008, 21(5) :350-352.
[3] 王晓蓉,任志斌,金卫东.齐拉西酮与奥氮平治疗精神分裂症对照研究引起体重和血糖增加的Meta分析[J].中国全科医学,2011,14(6):596-597.
[4] Bowden CL, Vieta E, Ice KS, et al.Ziprasidone plus a mood stabilizer in subjects with bipolar I disorder: a 6-month, randomized, placebo-controlled, double-blind trial[J].J Clin Psychiatry, 2010 ,71(2):130-137.
[5] Dubovsky SL, Dubovsky AN.Ziprasidone for maintenance treatment of bipolar I disorder in adults[J]. Expert Opin Pharmacother, 2011,12(5):817-824.
[6] 马永春,金卫东.齐拉西酮治疗双相心境障碍[J].国际精神病学杂志,2009,36(3):181-183.
[7] Keck PE Jr, Versiani M, Potkin S, et al.Ziprasidone in Mania Study Group. Ziprasidone in the treatment of acute bipolar mania: a three-week, placebo-controlled, double-blind, randomized trial[J].Am J Psychiatry,2003 ,160(4):741-748.
[8] Potkin SG, Keck PE Jr, Segal S, et al.Ziprasidone in acute bipolar mania: a 21-day randomized, double-blind, placebo-controlled replication trial[J].J Clin Psychopharmacol,2005, 25(4): 301-310.
[9] Kim E, Maclean R, Ammerman D, et al.Time to psychiatric hospitalization in patients with bipolar disorder treated with a mood stabilizer and adjunctive atypical antipsychotics: a retrospective claims database analysis[J]. Clin Ther, 2009,31(4):836-848.
[10] Kim E, You M, Pikalov A, et al.One-year risk of psychiatric hospitalization and associated treatment costs in bipolar disorder treated with atypical antipsychotics: a retrospective claims database analysis[J].BMC Psychiatry, 2011,7(11):6.