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首页> 外文期刊>The journal of clinical psychiatry >Osmotic-Release Oral System Methylphenidate Augmentation of Antidepressant Monotherapy in Major Depressive Disorder: Results of a Double-Blind, Randomized, Placebo-Controlled Trial.
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Osmotic-Release Oral System Methylphenidate Augmentation of Antidepressant Monotherapy in Major Depressive Disorder: Results of a Double-Blind, Randomized, Placebo-Controlled Trial.

机译：渗透释放口服系统哌醋甲酯增强抗抑郁药单一疗法在主要抑郁症中的作用：双盲，随机，安慰剂对照试验的结果。

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OBJECTIVE: To evaluate the efficacy, safety, and tolerability of adjunctive osmotic-release oral system (OROS) methylphenidate in outpatients with major depressive disorder (MDD) receiving a stable oral antidepressant regimen. METHOD: This multicenter, double-blind, randomized, placebo-controlled, parallel-group, 5-week trial enrolled 145 subjects who met DSM-IV-TR criteria for MDD and who had failed 1 to 3 previous antidepressant monotherapies (including current antidepressant) of adequate dose and duration. Augmentation therapy was initiated with 18 mg of OROS methylphenidate and increased to a maximum dose of 54 mg of OROS methylphenidate until an optimal dose was achieved. Efficacy scales included the Montgomery-Asberg Depression Rating Scale (MADRS), 7 atypical items from the 31-item Hamilton Rating Scale for Depression, the Clinical Global Impressions-Severity of Illness (CGI-S) scale, the CGI-Improvement scale (CGI-I), the Sex Effects scale, the Multidimensional Assessment of Fatigue (MAF) scale, and the Apathy Evaluation Scale (AES). Subjects were recruited at 17 community and academic centers across Canada. The study was conducted from June 8, 2005, to April 18, 2006. RESULTS: There was no statistically significant difference between the groups at endpoint on the MADRS. OROS methylphenidate was superior to placebo in improving apathy and fatigue as measured by the AES and the MAF. Statistically significant differences using mixed-model analysis were observed on the AES at all visits and at endpoint (p = .01) and on the MAF (p < .01). No differences were observed on other secondary measures, including the CGI-I and CGI-S. There were no clinically significant findings on electrocardiogram. CONCLUSIONS: OROS methylphenidate did not demonstrate statistical significance on the MADRS at endpoint. Apathy and fatigue were significantly improved with OROS methylphenidate treatment, which was well tolerated with minimal side effects. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov identifier NCT00246233.
机译：目的：评价哌替啶辅助渗透释放系统（OROS）对接受稳定口服抗抑郁方案的重度抑郁症（MDD）门诊患者的疗效，安全性和耐受性。方法：这项多中心，双盲，随机，安慰剂对照，平行组，为期5周的研究招募了145位符合MDM DSM-IV-TR标准且以前的1至3种抗抑郁药单一疗法（包括目前的抗抑郁药）无效的受试者）的剂量和持续时间。用18 mg OROS哌醋甲酯开始增强治疗，并增加到最大剂量54 mg OROS哌醋甲酯直至达到最佳剂量。疗效量表包括蒙哥马利-阿斯伯格抑郁量表（MADRS），第31项汉密尔顿抑郁量表中的7个非典型项，临床总体印象-疾病严重度量表（CGI-S），CGI改善量表（CGI） -I），性别影响量表，疲劳多维评估（MAF）量表和冷漠评估量表（AES）。在加拿大的17个社区和学术中心招募了受试者。该研究于2005年6月8日至2006年4月18日进行。结果：MADRS终点两组之间无统计学差异。如通过AES和MAF所测，OROS哌醋甲酯在改善冷漠和疲劳方面优于安慰剂。使用混合模型分析在所有访问，终点（p = .01）和MAF（p <.01）上观察到统计学上的显着差异。在其他辅助措施（包括CGI-I和CGI-S）上未观察到差异。心电图检查无临床意义。结论：OROS哌醋甲酯对终点的MADRS没有显示统计学意义。 OROS哌醋甲酯治疗可显着改善冷漠和疲劳感，且耐受性良好，且副作用极小。临床试验注册：ClinicalTrials.gov标识符NCT00246233。

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