奥氮平联合舍曲林与奥氮平联合安慰剂治疗精神病性抑郁症的双盲随机对照试验：精神病性抑郁症药物治疗研究（STOP-PD）
A double-blind randomized controlled trial of olanzapine plus sertraline vs olanzapine plus placebo for psychotic depression: the study of pharmacotherapy of psychotic depression (STOP-PD).
作者信息
Meyers Barnett S, Flint Alastair J, Rothschild Anthony J, Mulsant Benoit H, Whyte Ellen M, Peasley-Miklus Catherine, Papademetriou Eros, Leon Andrew C, Heo Moonseong
机构信息
Department of Psychiatry, Weill Medical College of Cornell University and New York Presbyterian Hospital, Westchester Division, White Plains, New York 10605, USA.
出版信息
Arch Gen Psychiatry. 2009 Aug;66(8):838-47. doi: 10.1001/archgenpsychiatry.2009.79.
CONTEXT
Evidence for the efficacy of combination pharmacotherapy has been limited and without positive trials in geriatric patients with major depression (MD) with psychotic features.
OBJECTIVES
To compare remission rates of MD with psychotic features in those treated with a combination of atypical antipsychotic medication plus a serotonin reuptake inhibitor with those treated with antipsychotic monotherapy; and to compare response by age.
DESIGN
Twelve-week, double-blind, randomized, controlled trial.
SETTING
Clinical services of 4 academic sites. Patients Two hundred fifty-nine subjects with MD with psychotic features randomized by age (<60 or > or =60 years) (mean [standard deviation (SD)], 41.3 [10.8] years in 117 younger adults vs 71.7 [7.8] years in 142 geriatric participants). Intervention Target doses of 15 to 20 mg of olanzapine per day plus masked sertraline or placebo at 150 to 200 mg per day. Main Outcome Measure Remission rates of MD with psychotic features.
RESULTS
Treatment with olanzapine/sertraline was associated with higher remission rates during the trial than olanzapine/placebo (odds ratio [OR], 1.28; 95% confidence interval [CI], 1.12-1.47; P < .001); 41.9% of subjects who underwent combination therapy were in remission at their last assessment compared with 23.9% of subjects treated with monotherapy (chi(2)(1) = 9.53, P = .002). Combination therapy was comparably superior in both younger (OR, 1.25; 95% CI, 1.05-1.50; P = .02) and older (OR, 1.34; 95% CI, 1.09-1.66; P = .01) adults. Overall, tolerability was comparable across age groups. Both age groups had significant increases in cholesterol and triglyceride concentrations, but statistically significant increases in glucose occurred only in younger adults. Younger adults gained significantly more weight than older subjects (mean [SD], 6.5 [6.6] kg vs 3.3 [4.9] kg, P = .001).
CONCLUSIONS
Combination pharmacotherapy is efficacious for the treatment of MD with psychotic features. Future research must determine the benefits vs risks of continuing atypical antipsychotic medications beyond 12 weeks.
TRIAL REGISTRATION
clinicaltrials.gov Identifier: NCT00056472.
背景
联合药物治疗疗效的证据有限，且尚无针对伴有精神病性特征的老年重度抑郁症（MD）患者的阳性试验。
目的
比较非典型抗精神病药物联合5-羟色胺再摄取抑制剂治疗与抗精神病药物单药治疗的伴有精神病性特征的MD患者的缓解率；并比较不同年龄组的反应。
设计
为期12周的双盲、随机、对照试验。
地点
4个学术机构的临床服务部门。患者259名伴有精神病性特征的MD患者，按年龄（<60岁或≥60岁）随机分组（平均[标准差（SD）]，117名年轻成年人中为41.3[10.8]岁，142名老年参与者中为71.7[7.8]岁）。干预目标剂量为每天15至20毫克奥氮平加150至200毫克/天的掩蔽舍曲林或安慰剂。主要观察指标伴有精神病性特征的MD患者的缓解率。
结果
在试验期间，奥氮平/舍曲林治疗组的缓解率高于奥氮平/安慰剂治疗组（优势比[OR]，1.28；95%置信区间[CI]，1.12 - 1.47；P <.001）；接受联合治疗的受试者中有41.9%在最后一次评估时缓解，而接受单药治疗的受试者中这一比例为23.9%（χ(2)(1)=9.53，P =.002）。联合治疗在年轻（OR，1.25；95% CI，1.05 - 1.50；P =.02）和老年（OR，1.34；95% CI，1.09 - 1.66；P =.01）成年人中均具有相当的优势。总体而言，各年龄组的耐受性相当。两个年龄组的胆固醇和甘油三酯浓度均显著升高，但仅年轻成年人的血糖有统计学意义的升高。年轻成年人比老年受试者体重增加明显更多（平均[SD]，6.5[6.6]千克对3.3[4.9]千克，P =.001）。
结论
联合药物治疗对伴有精神病性特征的MD有效。未来研究必须确定超过12周继续使用非典型抗精神病药物的利弊。
试验注册
clinicaltrials.gov标识符：NCT00056472。
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