1 Department of Psychiatry and Neurobehavioral Sciences, University of Virginia, Charlottesville, Virginia, USA.
2 Formerly AstraZeneca Pharmaceuticals, Wilmington, Delaware, USA.
CNS Spectr. 2014 Apr;19(2):182-96. doi: 10.1017/S1092852913000631. Epub 2013 Sep 25.
We evaluated sexual functioning from 6 acute, randomized, placebo-controlled studies (6-10 weeks) of once-daily extended release quetiapine fumarate (quetiapine XR) 50, 150, or 300 mg/day as monotherapy (Studies 1-4) or adjunct therapy (Studies 6-7) in major depressive disorder (MDD).
We present a pre-planned, non-inferiority analysis of quetiapine XR monotherapy versus placebo using Changes in Sexual Functioning Questionnaire (CSFQ) total score change (Studies 1-4). Post hoc analyses evaluated CSFQ total and domain scores for fixed-dose monotherapy (Studies 1-2), modified fixed-dose (Studies 3-4), and adjunct therapy studies (Studies 6-7). CSFQ data for active comparators (duloxetine [Study 2], escitalopram [Study 4]) are reported.
Quetiapine XR monotherapy was non-inferior to placebo for sexual functioning (least squares mean [LSM] difference in CSFQ score change versus placebo, 0.16 [95% confidence interval: -0.59, 0.92]); LSM change in CSFQ score: 1.90, quetiapine XR (all doses) and 1.73, placebo. LSM differences versus placebo (95% confidence interval): 0.18 (-1.40, 1.75), duloxetine (Study 2); 0.16 (-1.77, 2.10), escitalopram (Study 4). LSM differences with adjunct quetiapine XR 150 mg/day (0.52; p = 0.338) or 300 mg/day (0.22; p = 0.679) were comparable with placebo plus antidepressants. Post hoc all-patient and gender-specific analyses were comparable for CSFQ total scores versus placebo with quetiapine XR 50, 150, or 300 mg/day, duloxetine, and escitalopram. Discussion Lack of negative effects on sexual functioning in patients with MDD may improve treatment acceptability.
Quetiapine XR (monotherapy or adjunct therapy) had an impact on sexual function that was comparable with placebo.
我们评估了来自 6 项急性、随机、安慰剂对照研究（6-10 周）的性功能，这些研究使用每日一次的富马酸喹硫平缓释片（喹硫平 XR）50、150 或 300mg 作为单药治疗（研究 1-4）或辅助治疗（研究 6-7）治疗重度抑郁症（MDD）。
我们报告了使用性功能变化问卷（CSFQ）总分变化对喹硫平 XR 单药治疗与安慰剂进行的预先计划的非劣效性分析（研究 1-4）。事后分析评估了固定剂量单药治疗（研究 1-2）、改良固定剂量（研究 3-4）和辅助治疗研究（研究 6-7）的 CSFQ 总分和领域评分。还报告了活性对照物（度洛西汀[研究 2]、依地普仑[研究 4]）的 CSFQ 数据。
喹硫平 XR 单药治疗在性功能方面非劣效于安慰剂（CSFQ 评分变化与安慰剂相比的最小二乘均值[LSMS]差异，0.16 [95%置信区间：-0.59，0.92]）；CSFQ 评分变化的 LSMS：喹硫平 XR（所有剂量）为 1.90，安慰剂为 1.73。与安慰剂相比的 LSMS 差异（95%置信区间）：0.18（-1.40，1.75），度洛西汀（研究 2）；0.16（-1.77，2.10），依地普仑（研究 4）。与辅助喹硫平 XR 150mg/天（0.52；p=0.338）或 300mg/天（0.22；p=0.679）的附加影响相当。与安慰剂加抗抑郁药相比，后验全患者和性别特异性分析中，喹硫平 XR 50、150 或 300mg/天、度洛西汀和依地普仑与安慰剂相比，CSFQ 总分的差异具有可比性。
在 MDD 患者中，对性功能没有负面影响可能会提高治疗的可接受性。
喹硫平 XR（单药治疗或辅助治疗）对性功能的影响与安慰剂相当。
