一项多剂量 Lu AA21004 治疗成人重度抑郁症的随机、双盲、安慰剂对照 8 周试验的疗效和耐受性。
A randomized, double-blind, placebo-controlled 8-week trial of the efficacy and tolerability of multiple doses of Lu AA21004 in adults with major depressive disorder.
机构信息
Poliklinika Neuron, Croatian Institute for Brain Research, Medical School, University of Zagreb, Zagreb, Croatia.
出版信息
J Clin Psychiatry. 2012 Jul;73(7):953-9. doi: 10.4088/JCP.11m07470.
OBJECTIVE
Lu AA21004 is an investigational multimodal antidepressant. This randomized controlled trial evaluated the efficacy and tolerability of multiple doses of Lu AA21004 versus placebo in adults with major depressive disorder (MDD).
METHOD
Adults diagnosed with MDD (based on DSM-IV-TR criteria) with a Montgomery-Asberg Depression Rating Scale (MADRS) score ≥ 26 were randomly assigned (1:1:1:1) to receive Lu AA21004 1 mg, 5 mg, or 10 mg or placebo for 8 weeks (between August 2008 and August 2009). The primary endpoint was reduction in 24-Item Hamilton Depression Rating Scale (HDRS-24) total score after 8 weeks of treatment compared with placebo for Lu AA21004 10 mg. Additional outcomes included response and remission rates, Sheehan Disability Scale (SDS), Clinical Global Impressions-Global Improvement scale (CGI-I), MADRS total score, and HDRS-24 total score in subjects with baseline Hamilton Anxiety Rating Scale (HARS) score ≥ 20. Adverse events were assessed throughout the study.
RESULTS
A total of 560 subjects (mean age = 46.4 years) were randomized. There was a statistically significant reduction from baseline in HDRS-24 total score at week 8 for Lu AA21004 10 mg vs placebo (P < .001). There were improvements (nominal P values < .05 with no adjustment for multiplicity) in HDRS-24 total score, response and remission rates, CGI-I score, MADRS total score, and HDRS-24 total score in subjects with baseline HARS score ≥ 20 at week 8 for all Lu AA21004 treatment groups vs placebo. No significant differences were seen in SDS scores between any dose of Lu AA21004 and placebo. The most common adverse events were nausea, headache, and dizziness.
CONCLUSIONS
After 8 weeks of treatment with Lu AA21004 10 mg, there was a significant reduction in HDRS-24 total score compared with placebo in adults with MDD. Lu AA21004 was well tolerated in this study.
TRIAL REGISTRATION
ClinicalTrials.gov identifier: NCT00735709.
目的
Lu AA21004 是一种正在研究的多模式抗抑郁药。这项随机对照试验评估了 Lu AA21004 与安慰剂在患有重度抑郁症（MDD）的成年人中的多次剂量的疗效和耐受性。
方法
根据 DSM-IV-TR 标准诊断为 MDD（基于 DSM-IV-TR 标准）的成年人，蒙哥马利-阿斯伯格抑郁评定量表（MADRS）评分≥26，随机分配（1:1:1:1）接受 Lu AA21004 1mg、5mg 或 10mg 或安慰剂治疗 8 周（2008 年 8 月至 2009 年 8 月）。主要终点是与安慰剂相比，Lu AA21004 10mg 治疗 8 周后 24 项汉密尔顿抑郁评定量表（HDRS-24）总分的降低。其他结果包括反应和缓解率、Sheehan 残疾量表（SDS）、临床总体印象-全球改善量表（CGI-I）、MADRS 总分以及基线汉密尔顿焦虑评定量表（HARS）评分≥20 的受试者的 HDRS-24 总分。整个研究过程中评估了不良事件。
结果
共有 560 名受试者（平均年龄=46.4 岁）被随机分配。与安慰剂相比，Lu AA21004 10mg 在第 8 周时 HDRS-24 总分有统计学显著降低（P<.001）。Lu AA21004 所有治疗组在第 8 周时基线 HARS 评分≥20 的受试者的 HDRS-24 总分、反应和缓解率、CGI-I 评分、MADRS 总分和 HDRS-24 总分均有改善（名义 P 值<.05，未对多重性进行调整）与安慰剂相比。Lu AA21004 与安慰剂之间在 SDS 评分上无显著差异。最常见的不良事件是恶心、头痛和头晕。
结论
在接受 Lu AA21004 10mg 治疗 8 周后，与安慰剂相比，MDD 成年患者的 HDRS-24 总分显著降低。在这项研究中，Lu AA21004 具有良好的耐受性。
试验注册
ClinicalTrials.gov 标识符：NCT00735709。
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