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非典型抗精神病药物能否有效治疗共病的双相情感障碍和兴奋剂依赖?一项随机双盲试验。

Do atypical antipsychotics effectively treat co-occurring bipolar disorder and stimulant dependence? A randomized, double-blind trial.

作者信息

Nejtek Vicki A, Avila Matthew, Chen Li-Ann, Zielinski Tanya, Djokovic Marija, Podawiltz Alan, Kaiser Kathryn, Bae Sejong, Rush A John

机构信息

Department of Psychiatry, University of North Texas Health Science Center at Fort Worth, TX 76107, USA.

出版信息

J Clin Psychiatry. 2008 Aug;69(8):1257-66. doi: 10.4088/jcp.v69n0808.

Abstract

OBJECTIVES

The primary objective was to compare the efficacy and tolerability of quetiapine and risperidone in the treatment of mood symptoms, drug cravings, and drug use in outpatients with concurrent DSM-IV-defined bipolar I or II disorder and cocaine or methamphetamine dependence.

METHOD

Men and women of all ethnic origins, 20 to 50 years of age, were eligible to participate. Persons were excluded if they were inpatients, met DSM-IV criteria for substance-induced mood disorder, had any other substance dependence, were euthymic or suicidal, had any life-threatening illnesses, or were currently receiving antipsychotic medications. Duration of the trial was 20 weeks. Study participants attended weekly visits and were evaluated for mood symptoms, drug cravings, drug use, and medication side effects. Treatment outcomes were analyzed using linear mixed models. Fixed-effects terms for medication group, study week, and group-by-study-week were included in the models. The study was conducted between October 2002 and November 2006.

RESULTS

Of 124 consenting outpatients, an evaluable sample of 80 patients who attended baseline and at least 1 follow-up study visit was formed. The mean +/- SD exit dose for quetiapine was 303.6 +/- 151.9 mg/day and 3.1 +/- 1.2 mg/day for risperidone. Both quetiapine (N = 42) and risperidone (N = 38) significantly improved manic and depressive symptoms and reduced drug cravings (p < .0005) compared to baseline. Decreased drug cravings were related to less frequent drug use (p = .03). The 2 medications did not significantly differ in their effects on mood symptoms, drug craving, or drug use.

CONCLUSIONS

Relative to baseline mood and drug-craving status, both quetiapine and risperidone were associated with manic, mixed, and depressive symptom improvement and reduced drug cravings. Both medications were well tolerated. The interpretation of these results is limited by the absence of a placebo control.

TRIAL REGISTRATION

clinicaltrials.gov Identifier: NCT00227123.

摘要

目的

主要目的是比较喹硫平和利培酮在治疗同时患有DSM-IV定义的双相I型或II型障碍以及可卡因或甲基苯丙胺依赖的门诊患者的情绪症状、药物渴望和药物使用方面的疗效和耐受性。

方法

所有种族、年龄在20至50岁之间的男性和女性均有资格参与。如果是住院患者、符合物质所致情绪障碍的DSM-IV标准、有任何其他物质依赖、心境正常或有自杀倾向、有任何危及生命的疾病或目前正在接受抗精神病药物治疗,则被排除在外。试验持续时间为20周。研究参与者每周就诊一次,并接受情绪症状、药物渴望、药物使用和药物副作用的评估。使用线性混合模型分析治疗结果。模型中纳入了药物组、研究周数以及药物组与研究周数交互项的固定效应项。该研究于2002年10月至2006年11月进行。

结果

在124名同意参与的门诊患者中,形成了一个由80名参加了基线检查和至少1次随访研究就诊的患者组成的可评估样本。喹硫平的平均±标准差退出剂量为303.6±151.9毫克/天,利培酮为3.1±1.2毫克/天。与基线相比,喹硫平组(N = 42)和利培酮组(N = 38)均显著改善了躁狂和抑郁症状,并减少了药物渴望(p <.0005)。药物渴望的减少与药物使用频率降低有关(p =.03)。两种药物在对情绪症状、药物渴望或药物使用的影响方面没有显著差异。

结论

相对于基线情绪和药物渴望状态,喹硫平和利培酮均与躁狂、混合和抑郁症状的改善以及药物渴望的减少有关。两种药物耐受性良好。由于缺乏安慰剂对照,这些结果的解释受到限制。

试验注册

clinicaltrials.gov标识符:NCT00227123。

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