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更新于：2026-02-27
Agomelatine
阿戈美拉汀
更新于：2026-02-27
概要
基本信息
最高研发阶段批准上市 |
首次获批日期 欧盟 (2009-02-19), |
最高研发阶段(中国)批准上市 |
特殊审评儿科研究计划 (欧盟) |
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结构/序列
分子式C15H17NO2 |
InChIKeyYJYPHIXNFHFHND-UHFFFAOYSA-N |
CAS号138112-76-2 |
关联
165
项与 阿戈美拉汀 相关的临床试验CTIS2025-522967-13-00
A multicenter randomized, controlled, single-blind, adaptive phase IV clinical trial to evaluate the efficiency and effectiveness of a pre-emptive pharmacogenetic strategy for antidepressant selection in patients with depressive disorder: The PREDICT adaptive clinical trial.
IRCT20090117001556N164
The effect of Agomelatine as an adjuvant therapy on the improvement of negative symptoms in patients with chronic schizophrenia: A randomized, double-blind, placebo-controlled trial
ACTRN12625000575437
Part A: Phase 1, Single- Ascending Dose Trial to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Pharmacodynamics of Agomelatine in Healthy Participants.
100 项与 阿戈美拉汀 相关的临床结果
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100 项与 阿戈美拉汀 相关的转化医学
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100 项与 阿戈美拉汀 相关的专利（医药）
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1,122
项与 阿戈美拉汀 相关的文献（医药）2026-06-01JOURNAL OF AFFECTIVE DISORDERS
Management of insomnia symptoms in depressed patients treated with agomelatine, mirtazapine and trazodone: A systematic review and meta-analysis
Review
作者: Zou, Min ; Tao, Shiwan ; Zhang, Xusheng ; Wang, Qiang ; Chen, Yang ; Deng, Renhao
BACKGROUND AND PURPOSE:
Insomnia is a common symptom in depressive disorder, affecting up to 80% of those patients. Evidences suggest that sleep symptom improvements could alleviating depressive symptoms and reducing relapse. This article evaluated the efficacy of three antidepressants-agomelatine, mirtazapine, and trazodone-in treating insomnia symptoms in depressed patients, with a focus on polysomnographic (PSG) data, subjective sleep experience, improvement in depressive symptoms, and adverse drug reactions.
METHODS:
A systematic search of PubMed, Cochrane Library, MEDLINE, Embase, and Web of Science was conducted for studies published from 1974 to August 2025; 30 studies (16 randomized controlled trials and 14 non-randomized controlled trials) were included. The primary outcomes were PSG measures; secondary outcomes included PSQI and HAMD scores, as well as adverse medication reactions.
RESULTS:
The PSG results showed that agomelatine may not significantly change percentage N1 of sleep period time (N1%) and Latency of REM sleep (L-REM). Mirtazapine significantly increased total sleep time (TST), slow-wave sleep of sleep period time (SWS%), and sleep efficiency (SE%), while reducing percentage wake after sleep onset of sleep period time (WASO%). Trazodone notably improved TST, and SE%. For adverse effects, agomelatine was well-tolerated; mirtazapine commonly caused weight gain and sedation; and trazodone frequently led to dizziness, sedation, headache, nausea, and somnolence.
CONCLUSION:
All three medications significantly enhance subjective sleep perception and alleviate depressive symptoms. However, agomelatine may lack a definitive effect on improving objective sleep parameters in depressed patients. Future studies should involve larger, high-quality trials with unified methodologies to strengthen the reliability of conclusions.
2026-05-01JOURNAL OF AFFECTIVE DISORDERS
Parietal alpha asymmetry as a diagnostic marker for depression and a predictive biomarker for anhedonia improvement after melatonergic antidepressant treatment
Article
作者: Chang, Hsin-An ; Chang, Wei-Chou ; Sack, Alexander T ; Chen, Li-Fen ; Chang, Chuan-Chia ; Lin, Ching-En
BACKGROUND:
Major depressive disorder (MDD) is often marked by anhedonia, a symptom poorly addressed by first-line antidepressants. While frontal alpha asymmetry (FAA) has been widely studied, findings are inconsistent. Recent evidence suggests parietal alpha asymmetry (PAA) may better capture reward-related dysfunction.
METHODS:
We examined resting-state EEG alpha asymmetry in 84 unmedicated MDD patients and 143 healthy controls (HCs). Patients received 8 weeks of agomelatine, a melatonergic antidepressant. Anhedonia was assessed with the Snaith-Hamilton Pleasure Scale (SHAPS) and the 5-item anhedonia subscale of the Montgomery-Åsberg Depression Rating Scale (MADRS).
RESULTS:
At baseline, MDD patients showed reduced PAA, especially at P7-P8, distinguishing them from HCs (AUC = 0.85). After treatment, depressive symptoms, anxiety, cognition, and anhedonia improved significantly. Lower baseline P3-P4 asymmetry predicted greater improvement in clinician-rated anhedonia, whereas FAA showed no predictive value. Sex-stratified analyses indicated F3-F4 abnormalities were specific to females, while P7-P8 changes were robust across sexes.
CONCLUSIONS:
PAA, particularly at P7-P8, demonstrated diagnostic utility, while P3-P4 asymmetry was associated with treatment-related improvement in anhedonia. This study extends prior work by including a larger unmedicated MDD cohort, focusing on melatonergic treatment, and employing subitem-level anhedonia measures. Findings support PAA as a state-sensitive biomarker for diagnostic classification and prognosis in MDD, warranting replication and mechanistic investigation.
2026-03-01JOURNAL OF PSYCHIATRIC RESEARCH
Altered electroencephalographic microstate dynamics in major depressive disorder and their modulation by melatonergic treatment
Article
作者: Chang, Wei-Chou ; Chang, Hsin-An ; Chang, Chuan-Chia ; Liang, Wei-Zhe ; Sack, Alexander T ; Lin, Yen-Yue ; Chu, Che-Sheng ; Huang, Cathy Chia-Yu
BACKGROUND:
The modulation of brain dynamics by melatonin antidepressants in patients with major depressive disorder (MDD) remains unclear.
METHODS:
Resting-state electroencephalographic (EEG) was recorded in 84 drug-free patients with MDD and 143 healthy controls. EEG data were collected at baseline and after 8-week agomelatine treatment. K-means clustering identified four canonical microstates (MS-A-D), and topographic analysis of variance assessed group differences.
RESULTS:
At baseline, patients with MDD showed increased occurrence and coverage of MS-C and MS-D, along with a higher transition probability between these two states, compared to healthy controls. In contrast, the duration and coverage of MS-A and MS-B, as well as their transition probabilities, were reduced in the MDD group. Following treatment, patients with MDD exhibited increased MS-A coverage and a higher transition probability from MS-A to MS-B, while the transition probability between MS-C and MS-D decreased. Several microstate parameters were normalized to those of healthy controls. Notably, MS-B occurrence negatively correlated with baseline anhedonia severity, although no microstate measures predicted changes in anhedonia over time.
CONCLUSIONS:
This study demonstrates altered EEG microstate dynamics in patients with MDD and provides insights into the neural mechanisms underlying MDD. Microstate abnormalities may serve as potential clinical biomarkers for MDD.
100 项与 阿戈美拉汀 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 广泛性焦虑障碍 | 澳大利亚 | 2010-08-09 | |
| 重度抑郁症 | 欧盟 | 2009-02-19 | |
| 重度抑郁症 | 欧盟 | 2009-02-19 | |
| 重度抑郁症 | 冰岛 | 2009-02-19 | |
| 重度抑郁症 | 冰岛 | 2009-02-19 | |
| 重度抑郁症 | 列支敦士登 | 2009-02-19 | |
| 重度抑郁症 | 列支敦士登 | 2009-02-19 | |
| 重度抑郁症 | 挪威 | 2009-02-19 | |
| 重度抑郁症 | 挪威 | 2009-02-19 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 躁郁症1型 | 临床3期 | 荷兰 | 2006-04-21 | |
| 抑郁症 | 临床2期 | 波兰 | 2014-11-03 | |
| 焦虑症 | 临床2期 | 匈牙利 | 2014-03-17 | |
| 强迫症 | 临床2期 | 英国 | 2010-03-29 | |
| 终末期肾脏病 | 临床1期 | 美国 | 2011-03-01 | |
| 自闭症 | 临床阶段不明 | 美国 | 2012-08-17 | |
| 疼痛 | 临床阶段不明 | 美国 | 2012-08-17 | |
| 帕金森病 | 临床前 | 中国 | 2025-11-30 | |
| 脑损伤 | 临床前 | 印度 | 2025-06-10 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床4期 | 123 | 壓醖廠鬱餘獵製獵遞糧(夢積憲鏇簾鹹膚觸鬱膚): P-Value = 0.90 | 不佳 | 2025-03-05 | |||
Placebo | |||||||
临床2期 | 87 | 選觸遞顧壓憲膚範醖淵(鏇觸願構襯鹽觸醖範築) = the development of novel precision medicines for neuropsychiatric disorders, today announced a favorable outcome from the planned interim analysis for the Phase 2b trial of ALTO-300 as an adjunctive treatment for patients with major depressive disorder (MDD). 壓範範觸觸餘膚繭簾遞 (蓋顧築蓋製製廠窪廠繭 ) | 积极 | 2025-02-12 | |||
临床2期 | 239 | (biomarker-characterized patients) | 艱糧蓋鹹遞夢簾鏇鏇醖(顧獵窪餘願夢鏇鬱艱獵) = 衊鑰願鏇繭簾繭遞鹽蓋 壓觸糧築積願鏇製範製 (憲艱鹹艱鏇鏇憲壓鹽遞 ) 更多 | 积极 | 2023-12-04 | ||
临床3期 | 222 | 簾襯網蓋鑰顧窪鬱積選(鹹鹽鏇窪醖窪積製醖膚) = 選憲襯窪遞壓製鹹範衊 鹹鏇糧蓋襯積餘憲襯蓋 (鏇蓋憲淵繭憲夢鏇夢築 ) | 积极 | 2013-06-01 | |||
Placebo | 簾襯網蓋鑰顧窪鬱積選(鹹鹽鏇窪醖窪積製醖膚) = 鏇鏇鹽糧範廠鏇範獵壓 鹹鏇糧蓋襯積餘憲襯蓋 (鏇蓋憲淵繭憲夢鏇夢築 ) | ||||||
临床4期 | 332 | 糧繭構顧獵願膚顧膚窪(糧積鏇糧繭鑰齋膚鬱醖) = 鑰廠鹹壓齋鑰糧艱鹹鏇 簾鹽憲糧顧觸構窪夢夢 (願壓蓋築餘網範鬱獵鏇 ) | 积极 | 2007-11-01 | |||
Venlafaxine 75-150 mg/day | 糧繭構顧獵願膚顧膚窪(糧積鏇糧繭鑰齋膚鬱醖) = 觸壓選壓窪鹹蓋鏇鏇製 簾鹽憲糧顧觸構窪夢夢 (願壓蓋築餘網範鬱獵鏇 ) |
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