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首页> 外文期刊>CNS spectrums >Sexual functioning in patients with major depressive disorder in randomized placebo-controlled studies of extended release quetiapine fumarate
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Sexual functioning in patients with major depressive disorder in randomized placebo-controlled studies of extended release quetiapine fumarate

机译：缓释富马酸喹硫平随机安慰剂对照研究中的重度抑郁症患者的性功能

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Objective 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). Methods 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. Results 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. Conclusion Quetiapine XR (monotherapy or adjunct therapy) had an impact on sexual function that was comparable with placebo.
机译：目的我们通过每日一次，每日一次50、150或300 mg富马酸喹硫平（喹硫平XR）的6项急性，随机，安慰剂对照研究（6-10周）评估了性功能，作为单药治疗（研究1-4）或重症抑郁症（MDD）的辅助治疗（研究6-7）。方法我们使用性功能问卷（CSFQ）总分变化（研究1-4），对喹硫平XR单药治疗与安慰剂进行了预先计划的非劣效性分析。事后分析评估了固定剂量单一疗法（研究1-2），改良固定剂量（研究3-4）和辅助疗法研究（研究6-7）的CSFQ总分和领域得分。报告了活性比较剂（度洛西汀[研究2]，依他普仑[研究4]）的CSFQ数据。结果Quetiapine XR单一疗法在性功能方面不逊于安慰剂（CSFQ评分变化与安慰剂的最小二乘均数[LSM]差异为0.16 [95％置信区间：-0.59、0.92]）; LSM在CSFQ评分中的变化：喹硫平XR（所有剂量）为1.90，安慰剂为1.73。 LSM与安慰剂的差异（95％置信区间）：0.18（-1.40，1.75），度洛西汀（研究2）; 0.16（-1.77，2.10），依他普仑（研究4）。辅助性喹硫平XR 150 mg /天（0.52; p = 0.338）或300 mg / day（0.22; p = 0.679）的LSM差异与安慰剂加抗抑郁药相当。事后所有患者和针对性别的分析在喹硫平XR 50、150或300 mg /天，度洛西汀和依他普仑中的CSFQ总分与安慰剂相当。讨论对MDD患者的性功能缺乏负面影响可能会改善治疗的可接受性。结论Quetiapine XR（单一疗法或辅助疗法）对性功能的影响与安慰剂相当。

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