预约演示
更新于：2025-07-05
Tandospirone Citrate
枸橼酸坦度螺酮
更新于：2025-07-05
概要
基本信息
非在研机构 |
最高研发阶段批准上市 |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构/序列
分子式C27H37N5O9 |
InChIKeyDMLGUJHNIWGCKM-DPFKZJTMSA-N |
CAS号112457-95-1 |
关联
32
项与 枸橼酸坦度螺酮 相关的临床试验CTR20244057
枸橼酸坦度螺酮片在健康受试者中空腹与餐后条件下开放、随机、单次给药、两制剂、两序列、四周期完全重复交叉设计生物等效性试验。
ChiCTR2500096450
A Real-world Study on the Effectiveness and Safety of Tandospirone in Treating Patients with Anxiety.
CTR20231315
枸橼酸坦度螺酮片在中国健康人群中空腹和餐后状态下单次给药的人体生物等效性临床试验
100 项与 枸橼酸坦度螺酮 相关的临床结果
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100 项与 枸橼酸坦度螺酮 相关的转化医学
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100 项与 枸橼酸坦度螺酮 相关的专利（医药）
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380
项与 枸橼酸坦度螺酮 相关的文献（医药）2025-07-01CNS DRUGS
Efficacy and Safety of Escitalopram Combined with Tandospirone Citrate in Treating Patients with Vascular Depression and Chronic Insomnia: A Randomized Controlled Trial
Article
作者: Zeng, Guiying ; Chen, Xinyan ; Chen, Ronghua ; Xiao, Yingchun ; Xie, Sengpei ; Chen, Hongbin ; Chen, Hui ; Wu, Shufang ; Wu, Weiwei
BACKGROUND AND OBJECTIVE:
Chronic sleeplessness is a primary clinical symptom of vascular depression (VaDep). We investigated the efficacy and safety of escitalopram plus tandospirone citrate for patients with VaDep and chronic insomnia and the potential correlation of insomnia severity with neurotransmitter indexes, including serotonin (5-HT), serotonin 2C receptor (5-HT2CR), serotonin 7 receptor (5-HT7R) in platelets, and plasma 5-HT.
METHODS:
This double-blind, randomized controlled study randomized patients with VaDep and chronic insomnia [Hamilton depression rating scale (HAMD) > 17 points] into a monotherapy group [escitalopram (10 mg once daily) plus placebo] or combined group [escitalopram (10 mg once daily) plus tandospirone citrate (10 mg three times daily)] by using a 1:1 assignment algorithm generated by SPSS 25.0 software. The primary endpoint was the change in sleep quality from baseline to week 12, evaluated by the Pittsburgh Sleep Quality Index (PSQI), polysomnography (PSG), Epworth Sleepiness Scale, and Asen Self-Rating Insomnia Scale (AIS). Secondary outcomes were the changes in depression and anxiety assessment and the levels of peripheral blood neurotransmitters from baseline to week 12, including HAMD, the Hamilton anxiety scale (HAMA), 5-HT, 5-HT2CR, 5-HT7R in platelets, and plasma 5-HT. The levels of 5-HT, 5-HT2CR, and 5-HT7R were detected with the enzyme-linked immunosorbent assay kits. The safety assessment included the Treatment-Emergent Symptom Scale and clinical and laboratory variables. The therapeutic improvement was analyzed by a generalized estimation equation.
RESULTS:
A total of 123 subjects (30.89% male) were included, with a mean age of 70.56 ± 6.37 (mean ± standard deviation, SD) years. In the monotherapy group, the baseline HAMD and PSQI scores (n = 61 for both) were 28.84 ± 2.49 and 14.16 ± 1.86, respectively. In the combined group, the baseline HAMD and PSQI scores (n = 62 for both) were 28.81 ± 2.51 and 14.21 ± 1.87, respectively. The HAMA and HAMD scores in both groups were significantly lower at weeks 4, 8, and 12 after treatment than before treatment (P < 0.001). Compared with the monotherapy counterpart, the combined group displayed significantly lower PSQI and AIS scores at weeks 4, 8, and 12 and improved PSG sleep macrostructure at week 12, including total sleep time (TST), sleep latency, sleep efficiency, sleep maintenance rate (SMT), wake time after sleep onset, and percentage of sleep in each phase. Platelet 5-HT, plasma 5-HT, and platelet 5-HT7R decreased in both groups at the end of weeks 4, 8, and 12 of treatment. Platelet 5-HT7R was moderately negatively correlated with the percentage of nonrapid eye movement 3 sleep time (N3). Plasma 5-HT was moderately positively correlated with PSQI and AIS and negatively with TST, SMT, nonrapid eye movement 2 sleep time (N2), and percentage of N2 sleep time. No statistical difference in the total incidence of adverse events was found between the two groups (P = 0.842).
CONCLUSIONS:
The statistically significant changes in PSG, PSQI, and AIS may indicate that the combination of escitalopram and tandospirone may improve, with a reasonable safety profile, the sleep quality of patients with VaDe. The clinical results observed were associated with changes in measures of plasma 5-HT and platelet 5HT7R; these findings suggest that a possible role of central serotonergic function in the mechanism of action of the drug combination in this trial could be a relevant subject of future studies.
CLINICAL TRIAL REGISTRY NUMBER:
ChiCTR2300075407.
2025-06-01Neuropsychopharmacology reports
Augmentation Therapy With Serotonin 5‐HT1A Receptor Partial Agonists on Cognitive Function in Depressive Disorders: A Systematic Review of Randomized Controlled Studies
Review
作者: Wada, Ayumu ; Newman‐Tancredi, Adrian ; Stickley, Andrew ; Sumiyoshi, Tomiki ; Yamada, Risa
ABSTRACT:
Objective:
The use of serotonin 5‐HT1A receptor partial agonists (5‐HT1A‐PAs) as an add‐on therapy has been associated with the enhancement of attention/processing speed in patients with schizophrenia. Also, 5‐HT1A receptors have been shown to play a role in the pathophysiology of mood disorders. There is compelling evidence supporting that stimulation of 5‐HT1A receptors accelerates antidepressant effects. Accordingly, this systematic review examines the ability of adjunctive treatment with 5‐HT1A‐PAs to improve cognitive function in patients with depressive symptoms.
Methods:
A literature search using PubMed, the Cochrane Library, and Web of Science databases was performed from 1987 to January 2024 to identify randomized controlled trials (RCTs) corresponding to the following inclusion criteria: (1) RCTs, (2) human studies; studies that (3) targeted patients with a psychiatric disorder (except for schizophrenia or schizoaffective disorder), (4) evaluated the effect of cognitive functions, (5) were written in English.
Results:
From the 80 studies initially screened, three met the inclusion criteria. Two of these studies dealt with vascular depression while one focused on major depressive disorder (MDD). In MDD, combined treatment with buspirone and melatonin was more efficacious in ameliorating subjective cognitive disturbances compared to the use of buspirone alone or the use of a placebo. Likewise, the combination of escitalopram–tandospirone was more advantageous than escitalopram alone for improving executive function and verbal fluency in patients with vascular depression.
Conclusions:
Further studies with novel 5‐HT1A receptor agonists are warranted to examine their potentially more robust benefits on cognitive performance in subjects suffering from mood deficits.
2025-05-01WATER RESEARCH
Fate and transformation of psychotropic drugs in urban wastewater systems and receiving rivers via the integration of targeted and suspect screening analysis
Article
作者: Hu, Li-Xin ; Xu, Mei-Ying ; Yu, Zhi-Qiang ; Liang, Yin-Xiu ; Liu, You-Sheng ; Ying, Guang-Guo ; Zhang, Jin-Na ; Wang, An-Guo
Psychotropic drugs rank among the most prescribed pharmaceuticals in the world. The ubiquitous occurrence of psychotropic drugs in the environment evoked rising concerns due to their various toxic effect on non-target organisms at low concentrations. However, the removal, transformation, and discharging of these drugs throughout wastewater treatment plants (WWTPs) have rarely been reported. Based on the targeted analysis and suspected screening, this study investigated the distribution of psychotropic drugs and their transformation products (TPs) within the entire treatment processes in WWTPs and their receiving rivers. The results indicated that 13 out of 47 psychotropic drugs are widely observed across wastewater, sludge, receiving river water, and sediment, respectively. The aqueous removal efficiencies of most psychotropic drugs exhibited their significant recalcitrance in wastewater treatment processes. For instance, venlafaxine (VEL) was slightly removed by 2.64 % and 10.8 % in these two WWTPs. The concentrations of oxazepam (OZP) and lamotrigine (LMT) dramatically increased after the overall treatment processes due to their metabolic conversion and regeneration processes, respectively. Given the recalcitrance of psychotropic drugs, the identified TPs generated within WWTPs were not abundant, but a wider variety of TPs were identified from human metabolites. A total of 25 TPs were identified via the suspect screening analysis, of which nine were newly identified. In receiving rivers, the risk quotient (RQ) presented OZP, sertraline (SER), and VEL posed high potential risks; the integration of the toxicological priority index (ToxPi) and the toxicity-weighted concentration (TWC) suggested TP-CIT-322 and TP-OCX-195 as the high-priority contaminants. Given the recalcitrance and environmental risks of psychotropic drugs and their TPs in WWTPs and environments, it is crucial for the further exploration of their effective treatment technologies and emission control strategies .
100 项与 枸橼酸坦度螺酮 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 |
|---|---|---|---|
| 焦虑症 | 中国 | 2003-05-21 | |
| 神经症性障碍 | 日本 | 1996-07-10 | |
| 心理生理性障碍 | 日本 | 1996-07-10 |
未上市
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 年龄相关性黄斑变性 | 临床3期 | - | 2009-04-01 | |
| 地图样萎缩 | 临床3期 | - | 2009-04-01 |
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临床结果
临床结果
适应症
分期
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临床4期 | 274 | High-dose tandospirone (60 mg/d) | 築繭艱窪鑰糧憲醖窪範(衊鹽淵鑰鹽齋積艱選遞) = 構鏇鏇願鏇觸鬱選夢糧 顧壓膚糧廠製廠衊範繭 (餘鹹製糧艱餘襯鹹觸蓋 ) 更多 | - | 2023-02-26 | ||
Low-dose tandospirone (30 mg/d) | 築繭艱窪鑰糧憲醖窪範(衊鹽淵鑰鹽齋積艱選遞) = 鏇餘淵顧積壓構餘築醖 顧壓膚糧廠製廠衊範繭 (餘鹹製糧艱餘襯鹹觸蓋 ) 更多 | ||||||
临床4期 | 274 | 淵艱網鏇醖鑰顧艱鬱蓋(齋襯構遞願艱淵壓艱夢) = 鏇鏇網顧範築積構製選 憲齋製獵醖鏇夢餘齋壓 (繭壓構鏇蓋構夢網網積 ) | - | 2022-08-01 | |||
淵艱網鏇醖鑰顧艱鬱蓋(齋襯構遞願艱淵壓艱夢) = 網遞築鑰鑰觸願艱繭觸 憲齋製獵醖鏇夢餘齋壓 (繭壓構鏇蓋構夢網網積 ) | |||||||
临床3期 | 772 | (AL-8309B 1.0%) | 襯夢鏇憲壓夢鹹顧襯醖(繭齋憲鹹憲遞鬱餘獵蓋) = 願襯餘廠蓋壓憲網鬱夢 簾糧夢餘觸蓋鹽範壓範 (壓壓鏇糧糧簾膚觸膚構, 鹹憲範夢顧壓醖齋憲積 ~ 觸網鑰齋憲鹹簾淵餘醖) 更多 | - | 2014-07-03 | ||
(AL-8309B 1.75%) | 襯夢鏇憲壓夢鹹顧襯醖(繭齋憲鹹憲遞鬱餘獵蓋) = 積襯簾壓糧觸願製鏇築 簾糧夢餘觸蓋鹽範壓範 (壓壓鏇糧糧簾膚觸膚構, 廠範廠衊選構膚網鑰遞 ~ 選觸淵簾鬱齋構遞夢襯) 更多 |
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