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首页> 美国卫生研究院文献>Neuropsychopharmacology >Efficacy and Safety of Olanzapine/Fluoxetine Combination vs Fluoxetine Monotherapy Following Successful Combination Therapy of Treatment-Resistant Major Depressive Disorder
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Efficacy and Safety of Olanzapine/Fluoxetine Combination vs Fluoxetine Monotherapy Following Successful Combination Therapy of Treatment-Resistant Major Depressive Disorder

机译：奥沙平/氟西汀组合与氟西汀单药治疗成功联合治疗抗药性重度抑郁症的疗效和安全性

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This study assessed prevention of relapse in patients with treatment-resistant depression (TRD) taking olanzapine/fluoxetine combination (OFC). Patients with major depressive disorder (MDD) who failed to satisfactorily respond to ⩾2 different antidepressants for ⩾6 weeks within the current MDD episode were acutely treated for 6–8 weeks, followed by stabilization (12 weeks) on OFC. Those who remained stable were randomized to OFC or fluoxetine for up to 27 weeks. Time-to-relapse was the primary efficacy outcome defined as 50% increase in Montgomery-Åsberg Depression Rating Scale score with Clinical Global Impressions−Severity of Depression score of ⩾4; hospitalization for depression or suicidality; or discontinuation for lack of efficacy or worsening of depression or suicidality. A total of 444 patients were randomized 1:1 to OFC (N=221) or fluoxetine (N=223). Time-to-relapse was significantly longer in OFC-treated patients compared with fluoxetine-treated patients (p<0.001). Treatment-emergent weight gain and some mean and categorical fasting metabolic changes were significantly greater in OFC-treated patients. Clinically significant weight gain (⩾7%) was observed in 55.7% of patients who remained on OFC throughout the study, including the relapse-prevention phase (up to 47 weeks). There were no significant differences between patients treated with OFC and fluoxetine in extrapyramidal symptoms or serious adverse events. We believe this is the first controlled relapse-prevention study in subjects with TRD that supports continued use of a second-generation antipsychotic beyond stabilization. A thorough assessment of benefits and risks (in particular metabolic changes) associated with continuing treatment with OFC or fluoxetine must be done based on individual patient needs.
机译：这项研究评估了服用奥氮平/氟西汀组合（OFC）的难治性抑郁症（TRD）患者的复发预防。在当前MDD发作期间未能对⩾2种不同的抗抑郁药满意地反应⩾6周的重度抑郁症（MDD）患者，需进行6-8周的急性治疗，然后在OFC上稳定（12周）。那些保持稳定的患者被随机分配至OFC或氟西汀长达27周。复发时间是主要的疗效结果，定义为蒙哥马利-奥斯伯格抑郁量表评分增加50％，临床总体印象-抑郁程度评分为⩾4；因抑郁或自杀而住院；或因缺乏疗效或抑郁或自杀倾向恶化而停药。总共444例患者按1：1的比例随机分配至OFC（N = 221）或氟西汀（N = 223）。与氟西汀治疗的患者相比，OFC治疗的患者的复发时间明显更长（p <0.001）。在OFC治疗的患者中，治疗后的体重增加以及一些平均和绝对的空腹代谢变化明显更大。在整个研究期间，包括预防复发的阶段（长达47周），仍有55.7％的患者在OFC上观察到临床上显着的体重增加（⩾7％）。 OFC和氟西汀治疗的患者在锥体外系症状或严重不良事件方面无显着差异。我们相信这是针对TRD受试者的首个控制性预防复发研究，该研究支持继续使用除稳定以外的第二代抗精神病药。必须根据个别患者的需要，对与继续使用OFC或氟西汀进行治疗有关的益处和风险（尤其是代谢变化）进行全面评估。

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