Fava Maurizio, Okame Takao, Matsushima Yuki, Perry Pamela, Weiller Emmanuelle, Baker Ross A
Massachusetts General Hospital, Boston, MA; Otsuka Pharmaceutical Co., Ltd., Tokyo, Japan; Otsuka Pharmaceutical Development and Commercialization Inc., Princeton, NJ; H. Lundbeck A/S, Valby, Denmark.
Int J Neuropsychopharmacol. 2017 Jan 1;20(1):22-30. doi: 10.1093/ijnp/pyw087.
Approximately 50% of patients with major depressive disorder do not respond adequately to their antidepressant treatment, underscoring the need for more effective treatment options. The objective of this study was to investigate the effect of adjunctive brexpiprazole on depressive symptoms in patients with major depressive disorder who were not responding to adjunctive or combination therapy of their current antidepressant treatments with several different classes of agents (NCT02012218).
In this 6-week, open-label, phase 3b study, patients with major depressive disorder who had an inadequate response to ≥1 adjunctive or combination therapy, in addition to history of ≥1 failure to monotherapy antidepressant treatment, were switched to adjunctive brexpiprazole. Efficacy was assessed by change from baseline to week 6 in Montgomery-Åsberg Depression Rating Scale total score. Patient functioning was assessed using the Sheehan Disability Scale and the Cognitive and Physical Functioning Questionnaire. Safety and tolerability were also assessed.
A total of 51/61 (83.6%) patients completed 6 weeks of treatment with adjunctive brexpiprazole. Improvements in depressive symptoms were observed (least squares mean change from baseline to week 6 in Montgomery-Åsberg Depression Rating Scale total score, -17.3 [P < .0001]) as well as improvements in general and cognitive functioning (mean changes from baseline to week 6: Sheehan Disability Scale, -3.1 [P < .0001]; Massachusetts General Hospital-Cognitive and Physical Functioning Questionnaire, -9.2 [P < .0001]). The most common adverse event was fatigue (14.8%); akathisia was reported by 8.2% of patients.
In patients with major depressive disorder who had switched to open-label adjunctive brexpiprazole following inadequate response to previous adjunctive or combination therapy, improvements were observed in depressive symptoms, general functioning, cognitive function, and energy/alertness.
约50%的重度抑郁症患者对抗抑郁治疗反应欠佳，这凸显了对更有效治疗方案的需求。本研究的目的是调查阿立哌唑辅助治疗对当前使用几种不同类型药物进行抗抑郁治疗时辅助治疗或联合治疗无效的重度抑郁症患者抑郁症状的影响（NCT02012218）。
在这项为期6周的开放标签3b期研究中，对≥1种辅助治疗或联合治疗反应欠佳且有≥1次单一抗抑郁治疗失败史的重度抑郁症患者，改用阿立哌唑辅助治疗。通过蒙哥马利-艾斯伯格抑郁评定量表总分从基线到第6周的变化评估疗效。使用希恩残疾量表以及认知与身体功能问卷评估患者功能。同时评估安全性和耐受性。
共有51/61（83.6%）名患者完成了6周的阿立哌唑辅助治疗。观察到抑郁症状有所改善（蒙哥马利-艾斯伯格抑郁评定量表总分从基线到第6周的最小二乘均值变化为-17.3[P <.0001]），同时总体和认知功能也有所改善（从基线到第6周的均值变化：希恩残疾量表为-3.1[P <.0001]；麻省总医院认知与身体功能问卷为-9.2[P <.0001]）。最常见的不良事件是疲劳（14.8%）；8.2%的患者报告有静坐不能。
在对先前辅助治疗或联合治疗反应欠佳后改用开放标签阿立哌唑辅助治疗的重度抑郁症患者中，观察到抑郁症状、总体功能、认知功能以及精力/警觉性均有所改善。
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