Department of "Borderline" Mental Pathology and Psychosomatic Disorders, Mental Health Research Center of the Russian Academy of Medical Science, Moscow, Russian Federation.
Neuropsychiatr Dis Treat. 2014 Apr 17;10:631-9. doi: 10.2147/NDT.S58994. eCollection 2014.
CHRONOS was a large naturalistic study designed to evaluate the effectiveness and safety of agomelatine in the management of patients with major depression in routine clinical practice.
Patients (n=6,276) with a moderate or severe major depressive episode without psychotic symptoms were treated initially as outpatients (80.2%) or in psychiatric facilities (19.8%) in 54 regions of the Russian Federation. Patients received a flexible-dosing regimen of agomelatine 25 mg or 50 mg once daily for 8 weeks, with frequent study visits (weeks 1, 2, 3, 4, 6, and 8).
Patients (mean age 44 years, 72.6% female) showed progressive improvement on the 17-item Hamilton Rating Scale for Depression (HAMD-17) total score from 22±6.9 at baseline to 4.7±4.7 at week 8 (P<0.0001). The proportion of responders (HAMD-17 decrease of ≥50%) was 90.1% and the proportion of remitters (HAMD-17 <7) was 79.1% at week 8. All individual HAMD-17 item scores improved rapidly, and the change relative to baseline was significant (P<0.0001) at week 1 and at each subsequent visit in all cases. There were corresponding rapid improvements in Clinical Global Impression Severity and Improvement scores. In the subgroup of patients with more severe illness (HAMD-17 ≥21 at baseline; n=3,478), the proportions of responders and remitters were 92.4% and 72.8%, respectively, at week 8.
Agomelatine was effective and well tolerated in a large sample of depressed patients in an observational treatment setting, and showed a rapid onset of benefit across all HAMD-17 items.
CHRONOS 是一项大型自然主义研究，旨在评估阿戈美拉汀在常规临床实践中治疗重度抑郁症患者的有效性和安全性。
无精神病症状的中度或重度重性抑郁发作患者（n=6276）最初在俄罗斯联邦的 54 个地区作为门诊患者（80.2%）或精神科病房患者（19.8%）接受治疗。患者接受阿戈美拉汀 25 或 50mg 每日 1 次的灵活剂量治疗 8 周，研究访视频繁（第 1、2、3、4、6 和 8 周）。
患者（平均年龄 44 岁，72.6%为女性）的 17 项汉密尔顿抑郁量表（HAMD-17）总分从基线时的 22±6.9 逐渐改善到第 8 周的 4.7±4.7（P<0.0001）。第 8 周时，应答者（HAMD-17 下降≥50%）比例为 90.1%，缓解者（HAMD-17<7）比例为 79.1%。所有 HAMD-17 单项评分均迅速改善，与基线相比，各单项评分在第 1 周和随后的每次访视中均有显著变化（P<0.0001）。临床总体印象严重度和改善评分也相应迅速改善。在基线 HAMD-17 评分≥21 的病情较重患者亚组（n=3478）中，第 8 周时应答者和缓解者的比例分别为 92.4%和 72.8%。
在观察性治疗环境中，阿戈美拉汀对大量重度抑郁患者有效且耐受良好，在所有 HAMD-17 项中均表现出快速获益。
