PDF(Pubmed)
Abstract：
BACKGROUND: The efficacy and safety of antidepressant augmentation therapy with aripiprazole (AATA) has been established; however, the ongoing effects of continuing aripiprazole after remission remain unclear because no studies have examined this issue.
OBJECTIVE: We aimed to explore the effect of AATA discontinuation on the major depressive disorder (MDD) recurrence risk in patients with remitted MDD after AATA.
METHODS: This 24-week, multicenter, placebo-controlled, double-blind, randomized trial evaluated recurrence risk in patients with MDD who achieved remission with AATA. Differences in MDD recurrence, as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, between the two groups were compared using survival analysis. The differences in depressive symptom severity and social functioning between the two groups were compared using a mixed model with repeated measures. Extrapyramidal symptoms and akathisia were also assessed.
RESULTS: Twenty-three participants were randomized and treated. Two patients in each group experienced recurrence during the study. Kaplan-Meier analysis with Log-rank comparison showed no difference in recurrence between groups (p = 0.642). No significant difference in interactions between group and period was observed in the 17-item Hamilton depression rating scale (p = 0.492) or the Social and Occupational Functioning Assessment Scale (p = 0.638). No patients developed extrapyramidal symptoms or akathisia.
CONCLUSIONS: Definitive conclusions could not be drawn owing to the small sample size. This study represents a starting point for investigating the safety of aripiprazole discontinuation on recurrence in patients with MDD who have achieved remission with AATA. Future studies with appropriate sample sizes calculated based on this study are needed.
OBJECTIVE: We aimed to explore the effect of AATA discontinuation on the major depressive disorder (MDD) recurrence risk in patients with remitted MDD after AATA.
METHODS: This 24-week, multicenter, placebo-controlled, double-blind, randomized trial evaluated recurrence risk in patients with MDD who achieved remission with AATA. Differences in MDD recurrence, as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, between the two groups were compared using survival analysis. The differences in depressive symptom severity and social functioning between the two groups were compared using a mixed model with repeated measures. Extrapyramidal symptoms and akathisia were also assessed.
RESULTS: Twenty-three participants were randomized and treated. Two patients in each group experienced recurrence during the study. Kaplan-Meier analysis with Log-rank comparison showed no difference in recurrence between groups (p = 0.642). No significant difference in interactions between group and period was observed in the 17-item Hamilton depression rating scale (p = 0.492) or the Social and Occupational Functioning Assessment Scale (p = 0.638). No patients developed extrapyramidal symptoms or akathisia.
CONCLUSIONS: Definitive conclusions could not be drawn owing to the small sample size. This study represents a starting point for investigating the safety of aripiprazole discontinuation on recurrence in patients with MDD who have achieved remission with AATA. Future studies with appropriate sample sizes calculated based on this study are needed.
摘要：
背景：阿立哌唑（AATA）抗抑郁增强疗法的疗效和安全性已经确立；然而，缓解后继续使用阿立哌唑的持续疗效尚不清楚,因为尚未有研究证实这一问题.
目的：我们旨在探讨停用AATA对重度抑郁症（MDD）患者在AATA术后缓解后复发风险的影响。
方法：这24周，多中心，安慰剂对照,双盲,随机试验评估了通过AATA获得缓解的MDD患者的复发风险.MDD复发的差异，根据精神疾病诊断和统计手册的定义，第五版,使用生存分析比较两组之间的差异。使用重复测量的混合模型比较了两组之间抑郁症状严重程度和社会功能的差异。还评估了锥体外系症状和静坐不能。
结果：23名参与者被随机分组并接受治疗。在研究期间，每组有两名患者出现复发。Kaplan-Meier分析与Log-rank比较显示组间复发无差异(p=0.642)。在17项汉密尔顿抑郁量表（p=0.492）或社会和职业功能评估量表（p=0.638）中，组和时期之间的相互作用没有显着差异。没有患者出现锥体外系症状或静坐不能。
结论：由于样本量小，无法得出明确的结论。这项研究是研究阿立哌唑停药对AATA缓解的MDD患者复发的安全性的起点。需要根据本研究计算适当样本量的未来研究。
目的：我们旨在探讨停用AATA对重度抑郁症（MDD）患者在AATA术后缓解后复发风险的影响。
方法：这24周，多中心，安慰剂对照,双盲,随机试验评估了通过AATA获得缓解的MDD患者的复发风险.MDD复发的差异，根据精神疾病诊断和统计手册的定义，第五版,使用生存分析比较两组之间的差异。使用重复测量的混合模型比较了两组之间抑郁症状严重程度和社会功能的差异。还评估了锥体外系症状和静坐不能。
结果：23名参与者被随机分组并接受治疗。在研究期间，每组有两名患者出现复发。Kaplan-Meier分析与Log-rank比较显示组间复发无差异(p=0.642)。在17项汉密尔顿抑郁量表（p=0.492）或社会和职业功能评估量表（p=0.638）中，组和时期之间的相互作用没有显着差异。没有患者出现锥体外系症状或静坐不能。
结论：由于样本量小，无法得出明确的结论。这项研究是研究阿立哌唑停药对AATA缓解的MDD患者复发的安全性的起点。需要根据本研究计算适当样本量的未来研究。
