Cheon Eun-Jin, Lee Kwang-Hun, Park Young-Woo, Lee Jong-Hun, Koo Bon-Hoon, Lee Seung-Jae, Sung Hyung-Mo
From the *Department of Psychiatry, Yeungnam University College of Medicine, Yeungnam University Medical Center, Daegu; †Department of Neuropsychiatry, Dongguk University Kyungju Hospital, Kyungju; ‡Department of Neuropsychiatry, Daegu Fatima Hospital; §Department of Psychiatry, Catholic University of Daegu School of Medicine; ∥Department of Psychiatry, Kyungpook National University School of Medicine, Daegu; and ¶Department of Neuropsychiatry, College of Medicine, Pochon Cha University, Cha Hospital, Gumi, Republic of Korea.
J Clin Psychopharmacol. 2017 Apr;37(2):193-199. doi: 10.1097/JCP.0000000000000663.
The purpose of this study was to compare the efficacy and safety of aripiprazole versus bupropion augmentation in patients with major depressive disorder (MDD) unresponsive to selective serotonin reuptake inhibitors (SSRIs).
This is the first randomized, prospective, open-label, direct comparison study between aripiprazole and bupropion augmentation. Participants had at least moderately severe depressive symptoms after 4 weeks or more of SSRI treatment. A total of 103 patients were randomized to either aripiprazole (n = 56) or bupropion (n = 47) augmentation for 6 weeks. Concomitant use of psychotropic agents was prohibited. Montgomery Asberg Depression Rating Scale, 17-item Hamilton Depression Rating scale, Iowa Fatigue Scale, Drug-Induced Extrapyramidal Symptoms Scale, Psychotropic-Related Sexual Dysfunction Questionnaire scores were obtained at baseline and after 1, 2, 4, and 6 weeks of treatment.
Overall, both treatments significantly improved depressive symptoms without causing serious adverse events. There were no significant differences in the Montgomery Asberg Depression Rating Scale, 17-item Hamilton Depression Rating scale, and Iowa Fatigue Scale scores, and response rates. However, significant differences in remission rates between the 2 groups were evident at week 6 (55.4% vs 34.0%, respectively; P = 0.031), favoring aripiprazole over bupropion. There were no significant differences in adverse sexual events, extrapyramidal symptoms, or akathisia between the 2 groups.
The present study suggests that aripiprazole augmentation is at least comparable to bupropion augmentation in combination with SSRI in terms of efficacy and tolerability in patients with MDD. Both aripiprazole and bupropion could help reduce sexual dysfunction and fatigue in patients with MDD. Aripiprazole and bupropion may offer effective and safe augmentation strategies in patients with MDD who are unresponsive to SSRIs. Double-blinded trials are warranted to confirm the present findings.
本研究旨在比较阿立哌唑与安非他酮增效治疗对选择性5-羟色胺再摄取抑制剂（SSRI）治疗无效的重度抑郁症（MDD）患者的疗效和安全性。
这是第一项阿立哌唑与安非他酮增效治疗的随机、前瞻性、开放标签、直接对照研究。在接受4周或更长时间的SSRI治疗后，参与者至少有中度严重的抑郁症状。总共103名患者被随机分为阿立哌唑组（n = 56）或安非他酮组（n = 47）进行为期6周的增效治疗。禁止同时使用精神药物。在基线以及治疗1、2、4和6周后获取蒙哥马利-阿斯伯格抑郁评定量表、17项汉密尔顿抑郁评定量表、爱荷华疲劳量表、药物所致锥体外系症状量表、精神药物相关性性功能障碍问卷评分。
总体而言，两种治疗均显著改善抑郁症状，且未引起严重不良事件。蒙哥马利-阿斯伯格抑郁评定量表、17项汉密尔顿抑郁评定量表和爱荷华疲劳量表评分以及缓解率方面无显著差异。然而，两组在第6周时的缓解率存在显著差异（分别为55.4%和34.0%；P = 0.031），阿立哌唑优于安非他酮。两组在不良性事件、锥体外系症状或静坐不能方面无显著差异。
本研究表明，在MDD患者中，就疗效和耐受性而言，阿立哌唑增效治疗至少与安非他酮联合SSRI增效治疗相当。阿立哌唑和安非他酮均可帮助减轻MDD患者的性功能障碍和疲劳。阿立哌唑和安非他酮可能为对SSRI无反应的MDD患者提供有效且安全的增效策略。有必要进行双盲试验以证实本研究结果。
