Gao Keming, Wu Renrong, Kemp David E, Chen Jun, Karberg Elizabeth, Conroy Carla, Chan Philip, Ren Ming, Serrano Mary Beth, Ganocy Stephen J, Calabrese Joseph R
Department of Psychiatry, University Hospitals Case Medical Center/Case Western Reserve University School of Medicine, 10524 Euclid Ave, 12th floor, Cleveland, OH 44106
J Clin Psychiatry. 2014 Oct;75(10):1062-8. doi: 10.4088/JCP.13m08847.
To study the efficacy and safety of quetiapine-XR as monotherapy or adjunctive therapy to a mood stabilizer in acute bipolar I or II depression with comorbid generalized anxiety disorder (GAD) and other comorbidities.
The study was conducted from January 2007 to November 2011. The Mini-International Neuropsychiatric Interview was used to ascertain the diagnosis of DSM-IV bipolar disorder, GAD, and other Axis I disorders. Eligible patients were randomly assigned to quetiapine-XR or placebo for up to 8 weeks. The Hamilton Depression Rating Scale-17 items (HDRS-17) was used as a primary outcome to evaluate the difference between the 2 groups using the change from baseline to end of study. Last observation carried forward and mixed-effects modeling for repeated measures were used to analyze the primary and secondary outcome measures.
Of the 120 patients screened, 100 patients were randomized to receive quetiapine-XR (n = 50) or placebo (n = 50). Twenty-six patients in the quetiapine-XR and 18 in the placebo group completed the study. The mean quetiapine-XR dose was 276 ± 50 mg/d (50-300 mg/d). There was no significant difference between the 2 groups in the change from baseline to end of study in HDRS-17 total score with an effect size of 0.19 favoring quetiapine-XR. There were also no significant differences between the 2 groups in secondary efficacy and safety outcome measures.
Quetiapine-XR was not significantly superior to placebo in bipolar I or II depression with GAD and other comorbidities, suggesting that data from relatively "pure" bipolar patients may not be generalizable to a highly comorbid population.
ClinicalTrials.gov identifier: NCT00671853.
研究喹硫平缓释片作为单一疗法或与心境稳定剂联合用于伴有共病广泛性焦虑障碍（GAD）及其他共病的急性双相I型或II型抑郁症的疗效及安全性。
研究于2007年1月至2011年11月进行。采用迷你国际神经精神访谈来确定DSM-IV双相情感障碍、GAD及其他I轴疾病的诊断。符合条件的患者被随机分配至喹硫平缓释片组或安慰剂组，治疗长达8周。采用汉密尔顿抑郁量表17项（HDRS-17）作为主要结局指标，通过比较基线至研究结束时的变化来评估两组间的差异。采用末次观察结转法和重复测量的混合效应模型分析主要和次要结局指标。
在筛选的120例患者中，100例患者被随机分配接受喹硫平缓释片（n = 50）或安慰剂（n = 50）治疗。喹硫平缓释片组26例患者和安慰剂组18例患者完成了研究。喹硫平缓释片的平均剂量为276±50 mg/d（50 - 300 mg/d）。两组在HDRS-17总分从基线至研究结束时的变化方面无显著差异，效应量为0.19，倾向于喹硫平缓释片。两组在次要疗效和安全性结局指标方面也无显著差异。
在伴有GAD及其他共病的双相I型或II型抑郁症中，喹硫平缓释片并不显著优于安慰剂，这表明来自相对“单纯”双相情感障碍患者的数据可能不适用于共病情况严重的人群。
ClinicalTrials.gov标识符：NCT00671853。
