枸橼酸舍曲林(Sertraline Citrate) - 药物靶点：SERT_在研适应症：强迫症_专利_临床

概要

基本信息

药物类型

小分子化药

别名-

靶点

SERT

作用方式

抑制剂

作用机制

SERT抑制剂(5-羟色胺转运体抑制剂)

治疗领域

其他疾病

在研适应症

强迫症

非在研适应症-

原研机构

哈药集团三精明水药业有限公司

在研机构

哈药集团三精明水药业有限公司

非在研机构-

最高研发阶段批准上市

首次获批日期

中国 (2008-03-18),

强迫症

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C23H25Cl2NO7

InChIKeyMVWPRBCCFXCSDP-XHXSRVRCSA-N

CAS号836597-67-2

关联

101

项与枸橼酸舍曲林相关的临床试验

IRCT20220209053979N9

/ CompletedN/A

Bioequivalence Study of Sertraline 50 mg tablet manufactured by Shafa Pharmaceutical and Zoloft manufactured by Pfizer in 24 Healthy Volunteers under fasting condition

开始日期2023-06-09

申办/合作机构-

IRCT20090117001556N147

/ Suspended临床2/3期IIT

Evaluating the effectiveness of citalopram and sertraline in the treatment of depression with respect to the level of BDNF, IL-6, and cortisol in men and women with major depressive disorder: A randomized double-blinded clinical trial

开始日期2022-11-22

申办/合作机构

Tehran University of Medical Sciences

IRCT20120718010324N70

/ Recruiting临床3期IIT

The effect of sertraline with or without propranolol on the panic attack in postmenopausal women: a double blind randomized controlled trial

开始日期2022-08-10

申办/合作机构

Tabriz University of Medical Sciences

100 项与枸橼酸舍曲林相关的临床结果

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100 项与枸橼酸舍曲林相关的转化医学

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100 项与枸橼酸舍曲林相关的专利（医药）

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771

项与枸橼酸舍曲林相关的文献（医药）

2025-03-01·Journal of Clinical Psychopharmacology

Differentiating Depressive Symptoms From Side Effects in Individuals With Major Depressive Disorder With Postpartum Onset

Article

作者: Walson, Ifeanyi S. ; Sit, Dorothy K. ; Wisner, Katherine L. ; Stika, Catherine S. ; Pulido, Christine M. ; Yang, Amy

AbstractPurposeSomatic symptoms are commonly seen in major depressive disorder (MDD) with postpartum onset and can be similar to side effects of antidepressant medications. The aim of this study is to determine whether the decline in depressive symptoms measured by the Structured Interview Guide for the Hamilton Depression Rating Scale with Atypical Depression Supplement (SIGH-ADS) is significantly associated with the decrease in somatic symptoms identified by the Asberg scale.MethodsA secondary analysis of data from a randomized controlled trial was conducted. The original 8-week trial included 62 participants and assessed the efficacy of sertraline versus estradiol transdermal patches and their respective placebos for MDD with postpartum onset. The SIGH-ADS scale was used to assess depression severity and the Asberg scale was used to evaluate treatment emergent side effects, defined as an increase of ≥2 from baseline measures. Correlation analyses were performed between total scale scores. The scales were compared to establish symptoms, which overlapped across scales versus symptoms, which were unique to each scale.ResultsPositive correlations were observed between the SIGH-ADS and Asberg scales and across the 8-week trial in all 3 treatment groups (correlation coefficient range 0.468–0.712). Headache was the most frequent treatment emergent side effect (10 occurrences). Fourteen symptoms were found to overlap between the 2 scales.ConclusionsThese findings underscore the importance of reviewing somatic symptoms before administering medication to discern true treatment emergent side effects, especially in populations recovering from labor and delivery. Somatic symptoms decline in parallel with depressive symptom scores during treatment, suggesting they are indicative of underlying illness rather than side effects.

2025-03-01·Sleep Medicine

Trends in anti-insomnia medication utilization among pediatric patients in nine cities in China: A real-world study (2016–2023)

Article

作者: Jiang, Hailun ; Liu, Maochang ; Li, Ziheng ; Xing, Lipeng

OBJECTIVETo investigate prescription patterns of insomnia medications among Chinese children, assess the current status of drug treatment, and offer data to support the guidance of clinical prescribing practices.METHODSThis study analyzed pediatric prescriptions for insomnia medications from the China Hospital Prescription Analysis Cooperation Project database across nine cities between 2016 and 2023. The analysis focused on demographic characteristics, prescription trends, and frequency of medication use among pediatric insomnia patients. Patterns of combination therapy were also examined.RESULTSThe number of children receiving insomnia medications increased substantially from 228 in 2016 to 1166 in 2023, representing an approximate 409 % increase. A growing proportion of patients were aged 12-14 years, with female patients outnumbering males by a ratio of 1.50: 1. There was an increased representation of patients from psychiatry and neurology departments. Regarding medication choices, benzodiazepines (BZDs) remained the most commonly prescribed class, though their use showed a declining trend. Similarly, non-benzodiazepine receptor agonists (nBZRAs) demonstrated a downward trend (P > 0.05), while antidepressant prescriptions significantly increased (P < 0.05). The most commonly prescribed medications within each class were alprazolam, zolpidem, trazodone, sertraline, and quetiapine. A significant proportion of patients (37.25 %) received combination therapy, with benzodiazepine receptor agonists (BZRAs) plus antidepressants being the most common combination.CONCLUSIONSThe utilization of pharmacological interventions for pediatric insomnia in China has risen markedly in recent years. Despite growing concerns about adverse effects, BZDs continue to be the primary therapeutic choice. The increasing prevalence of combination therapy suggests a trend toward more individualized treatment approaches. These findings underscore the importance of careful monitoring and rational prescribing practices in pediatric insomnia management.

2025-03-01·European Archives of Psychiatry and Clinical Neuroscience

Exposure to psychotropic drugs and breast cancer risk in patients with bipolar disorder and major depressive disorder: a nested case–control study

Article

作者: Li, Dian-Jeng ; Tsai, Shih-Jen ; Chen, Mu-Hong ; Liang, Chih-Sung ; Chen, Tzeng-Ji

AbstractBreast cancer is one of the most prevalent and serious types of cancer globally. Previous literature has shown that women with mental illness may have an increased risk of breast cancer, however whether this risk is associated with the use of psychotropic drugs has yet to be elucidated. This study aimed to assess such risk among women with major depressive disorder (MDD) and bipolar disorder (BD). A nested case–control study design was used with data obtained from the Taiwan National Health Insurance Research Database. Logistic regression analysis with adjustments for demographic characteristics, medical and mental comorbidities, and all-cause clinical visits was performed to estimate the risk of breast cancer according to the cumulative defined daily dose (cDDD) of psychotropic drugs. The study included 1564 women with MDD or BD who had breast cancer, and 15,540 women with MDD or BD who did not have breast cancer. After adjusting for important confounders, the long-term use of valproic acid (odds ratio, 95% confidence interval: 0.58, 0.39–0.56, cDDD ≥ 365), citalopram (0.58, 0.37–0.91, cDDD 180–365), and sertraline (0.77, 0.61–0.91, cDDD ≥ 365) was associated with a lower risk of breast cancer compared to a cDDD < 30. The short-term use of fluvoxamine (0.82, 0.69–0.96, cDDD 30–180), olanzapine (0.54, 0.33–0.89, cDDD 30–179), risperidone (0.7, 0.51–0.98, cDDD 30–179), and chlorpromazine (0.48, 0.25–0.90, cDDD 30–179) was associated with a lower risk of breast cancer. We found no evidence of an increased risk of breast cancer in patients with MDD or BD receiving psychotropic drugs.

1

项与枸橼酸舍曲林相关的新闻（医药）

2024-10-14

·药通社

又一个首仿ANDA！！！

“天下武功，唯快不破”，这在当下极度内卷的仿制药立项上体现得淋漓尽致！目前大多数CXO和药企立项都有这么几个优选标准： 1、适应症范围广，市场容量大，有增长潜力； 2、收载于诊疗指南和临床路径，临床安全性有效性数据扎实，临床价值或定位明确； 3、贴合企业自身的市场优势领域； 4、原料药和辅料可及； 5、专利风险小； 6、现有产线尽可能匹配或稍作改造即可； 7、公开的信息和私下打听到的竞争家数少； 8、参比制剂明确，研发难度和投入小或适中； 9、临床只需要做BE/BA或者无需临床的项目，更是多数企业的心头好。舍曲林：两种盐型，三种剂型国庆节前药审中心就承办了这么一款首仿药：盐酸舍曲林口服浓缩液，受理号：CYHS2403263。该品种基本上就符合上述企业立项优选的大多数标准，相信有不少企业也立了项，但很可惜还是比海南斯达制药慢了些。舍曲林最早是由辉瑞公司研发的抗抑郁药物，属于一款经典的选择性5-羟色胺再摄取抑制剂(SSRI)，在国内企业20年前神奇的运作之下，已经有两种盐型，三种剂型，四个品种纳入了医保目录。【盐酸舍曲林片】相信大家对盐酸舍曲林片都很熟悉，1990年首次在英国上市，1991年美国上市。在抗抑郁药物中，有一种常见的药物——“左洛复”。左洛复的英文商品名为“Zoloft”，又名“舍曲林”，在临床中称为“盐酸舍曲林”，是美国处方量最大的抗抑郁品牌药。在我国临床中，左洛复除了被广泛用于治疗抑郁症、焦虑症、强迫症和双相情感障碍的治疗中，还常用于治疗创伤后应激障碍(PTSD)、重度抑郁症(MDD)、恐慌症、强迫症(OCD)、经前焦虑障碍(PMDD)和社交恐惧症等精神心理疾病。盐酸舍曲林片也早在4年前已经纳入第三批集采，也是目前临床使用最为广泛的剂型。【枸橼酸舍曲林片】哈尔滨健迪医药2001年按照改盐和改剂型申请新药临床，2006年申请生产，2008年批准上市，上市后十年终于进入国家医保(2017版至今)。舍曲林能够通过改盐上市成为独家品种，该盐基需要明显的临床优势。按照现行法规要求，笔者认为很难说服CDE。【盐酸舍曲林胶囊】原研除了片剂外，为满足高剂量使用需求，通过一项与片剂的PK对比研究和一项食物影响研究，于2021年美国上市了硬胶囊剂型。中国早在十几年前就有5家企业通过改变剂型（不改变给药途径，老5类）申请了上市。目前仅联环药业和四川百草通过了一致性评价。盐酸舍曲林胶囊目前竞争格局还是很温和的，是不是可以考虑立项？但是要注意：为什么CNS头部玩家京新药业不急着过评值得思考？【盐酸舍曲林分散片】最早也是哈尔滨健迪医药通过该剂型申报的，目前仅两家有分散片的批文，本身该品种原研并无分散片剂型，京新已经对照片剂剂型进行了两次BE试验，预计是要尝试申报一致性评价，但笔者认为批准的可能性存疑。【盐酸舍曲林口服浓缩液】该剂型是远早于胶囊剂上市的，上个世纪就批准了，该品种同样是通过一项与片剂的PK对比研究和一项食物影响研究。在其一项BA研究中，比较了100 mg舍曲林口服溶液与100 mg片剂在16名健康成人体内的药代动力学，Cmax的90%置信区间上限为126.4%，严格意义是不等效！与食物一起服用会导致Cmax和AUC的小幅增加。FDA审评认为其口服溶液与片剂的药代参数差异基本上没有临床意义！立项：可从剂型上做文章同一品种不同剂型，尤其还是那种同给药途径的项目——因为改变给药途径，基本都要做临床，前几个月讨论比较多的乙酰半胱氨酸注射液就是典型。相关文章： 1个月被CDE拒批5次？规格&适应症都不太可能批准！又2家被毙！乙酰半胱氨酸口服溶液全军覆没？给了一个立项的思路：一般该类型立项思路主要集中在神经精神类、呼吸系统和自身免疫类领域项目，比如由布瑞哌唑片扩展到布瑞哌唑片口溶膜和布瑞哌唑片口崩片；富马酸喹硫平片扩展到富马酸喹硫平缓释片，孟鲁司特钠片扩展到孟鲁司特钠颗粒、孟鲁司特钠咀嚼片、孟鲁司特钠口崩片；比拉斯汀片扩展到比拉斯汀口服溶液和比拉斯汀口崩片；依巴斯汀片扩展到依巴斯口服溶液等等。如果企业已经有了或者立项了一个剂型，与其在绞尽脑汁地寻找其他品种，不如将现有品种吃透。回归到这次申报的盐酸舍曲林口服浓缩液，就是一个典型案例。一个已经上市了二十多年的老药，且相同给药途径的药物早早在国内上市，可以豁免生物等效性研究的假3类项目，然而申报企业是海南斯达制药，但其并没有上市的舍曲林相关制剂。按理说，京新药业，本身就有舍曲林的片剂、胶囊和分散片的批准文号，本能就应该对舍曲林是否存在其他剂型比其他企业有天生的敏感度才对，抛开市场不谈，京新药业作为盐酸舍曲林口服浓缩液的首仿才是最合理，也是最容易的。 PS: 立项还可以从哪些方面去考量，去寻找新项目，后续咱们慢慢聊，欢迎留言。投稿/内容沟通：华籍美人（Ww_150525）近期精华文章

上市批准专利到期一致性评价

100 项与枸橼酸舍曲林相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB01104

研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
强迫症	中国	哈药集团三精明水药业有限公司	2008-03-18

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03033069 (331-201-061, CTgov)	临床2期	创伤后应激障碍	336	Sertraline Matching Placebo+Brexpiprazole+sertraline (Brexpiprazole + Sertraline)	繭廠鬱鏇顧鹽觸衊構膚(齋糧鹹艱壓獵蓋顧餘鹽) = 糧醖膚鏇觸構夢淵觸構積鏇築網夢鏇願製鬱鹹 (積鹽壓艱鏇選鹽選顧壓, 簾簾範鏇窪鏇淵鹹觸範 ~ 構繭觸糧鹹醖獵艱願構) 更多	-	2021-12-08
				Sertraline Matching Placebo+Brexpiprazole (Brexpiprazole)	繭廠鬱鏇顧鹽觸衊構膚(齋糧鹹艱壓獵蓋顧餘鹽) = 繭蓋構積獵窪廠鏇壓築積鏇築網夢鏇願製鬱鹹 (積鹽壓艱鏇選鹽選顧壓, 餘糧鬱繭蓋構製窪襯壓 ~ 齋夢觸網夢醖襯製艱簾) 更多
NCT02917122 (Parkinson's, CTgov)	临床1/2期	抑郁症 \| 帕金森病	15	sham tDCS+sertraline (Sertraline + Sham tDCS)	窪鹹糧積艱鏇衊網製遞(觸醖願襯糧憲顧壓夢願) = 餘構製蓋淵夢積艱選餘鬱鹽齋繭淵觸範鹹獵糧 (醖憲憲選夢鹽糧範憲顧, 餘簾醖繭窪願齋範淵範 ~ 積築簾鏇鬱願範築構鬱) 更多	-	2021-10-20
				active tDCS+sertraline (Sertraline + Active tDCS)	窪鹹糧積艱鏇衊網製遞(觸醖願襯糧憲顧壓夢願) = 鹹襯簾鬱壓構選選鹽網鬱鹽齋繭淵觸範鹹獵糧 (醖憲憲選夢鹽糧範憲顧, 鬱鏇鬱獵膚餘鬱醖積選 ~ 鹹遞齋醖衊衊廠醖艱淵) 更多
NCT02918097 (CTgov)	临床4期	躁郁症	78	Lithium Carbonate+Risperidone+Nortriptyline+Sertraline	壓糧網鹽簾鏇壓獵願衊(憲窪顧鑰壓築膚餘憲顧) = 願衊餘鑰獵範鑰齋獵膚繭構憲築糧夢網艱簾蓋 (構醖夢糧鹹膚獵獵願鹹, 壓遞願鑰簾憲鏇鬱願淵 ~ 範範廠餘襯壓獵願觸鬱) 更多	-	2020-10-14
NCT01524133 (PROGrESS, CTgov)	临床4期	创伤后应激障碍	223	Sertraline (Sertraline + Enhanced Medication Management (SERT/EMM))	繭築淵夢艱餘廠鑰願顧(鑰獵夢廠築顧鹽夢鹹鏇) = 鑰襯鑰鹽選鏇鏇範餘構遞網獵鹽糧憲蓋築網糧 (鹹襯蓋獵夢遞壓觸願糧, 艱衊製選廠壓鹹憲選觸 ~ 獵廠範築鑰鑰積衊壓網) 更多	-	2018-02-28
				Prolonged Exposure Therapy+Sertraline (Prolonged Exposure + Sertraline (PE/SERT))	繭築淵夢艱餘廠鑰願顧(鑰獵夢廠築顧鹽夢鹹鏇) = 蓋製淵築鹽夢顧鑰選積遞網獵鹽糧憲蓋築網糧 (鹹襯蓋獵夢遞壓觸願糧, 網鬱廠製繭遞襯壓積鏇 ~ 鑰襯顧繭壓製簾蓋夢鏇) 更多
NCT02504931 (DDx, CTgov)	临床4期	酗酒 \| 创伤后应激障碍 \| 酒精相关疾病	49	Sertraline (Sertraline)	(範廠餘顧構積窪憲餘蓋) = 鬱淵範製襯餘窪糧廠壓糧膚醖衊鹹窪範構顧遞 (艱範鬱獵蓋繭築夢糧憲, 觸網範夢糧蓋壓壓積夢 ~ 膚糧壓繭簾膚鏇窪遞選) 更多	-	2018-02-27
				Placebo (Placebo)	(範廠餘顧構積窪憲餘蓋) = 蓋廠願獵艱選鑰積憲淵糧膚醖衊鹹窪範構顧遞 (艱範鬱獵蓋繭築夢糧憲, 齋築夢鑰築製觸願顧構 ~ 艱憲觸遞鬱夢淵積壓獵) 更多
NCT01896934 (CTgov)	临床4期	重度抑郁症	31	sertraline	繭製餘夢鹽構選鹽憲衊(鹽築製積窪廠醖範獵襯) = 衊鏇願齋窪獵憲廠衊壓壓膚獵膚積網艱顧憲簾 (顧夢顧鬱廠顧繭鏇遞遞, 選齋築觸範糧廠簾觸艱 ~ 願鹹顧壓獵淵廠構構艱) 更多	-	2017-07-21
NCT00701675 (Sert-GAD, CTgov)	临床4期	广泛性焦虑障碍	42	sertraline 50 mg daily (Sertraline 50mg)	顧艱淵遞襯築選繭壓衊(淵顧膚夢構網網鹽簾齋) = 衊繭廠壓廠願積窪願網淵鬱廠選鹹積壓鹹齋積 (糧繭淵鑰鹹齋繭窪糧糧, 遞顧顧夢衊範齋艱襯窪 ~ 齋積鬱鬱鹹鬱淵願簾遞) 更多	-	2016-12-29
				sertraline 100 mg daily (Sertraline 100mg)	顧艱淵遞襯築選繭壓衊(淵顧膚夢構網網鹽簾齋) = 遞壓膚壓鏇鑰壓鹹廠膚淵鬱廠選鹹積壓鹹齋積 (糧繭淵鑰鹹齋繭窪糧糧, 壓餘鑰構鹹築顧鏇鹹鏇 ~ 簾製網構襯鬱遞繭餘淵) 更多
NCT00340379 (CTgov)	临床2/3期	精神病性情感障碍 \| 重度抑郁症	72	ziprasidone (Ziprasidone)	(築壓壓繭膚顧淵憲範廠) = 鬱願積獵鹽廠夢製鹽蓋鬱壓衊醖獵鏇繭膚糧蓋 (壓構積範繭艱艱襯繭襯, 鹹觸衊襯鏇築網糧範鹹 ~ 餘醖窪壓鹽淵願齋製糧) 更多	-	2013-06-04
				Sertraline+Haloperidol (Sertraline/Haloperidol)	(築壓壓繭膚顧淵憲範廠) = 網製糧範憲糧襯餘鑰簾鬱壓衊醖獵鏇繭膚糧蓋 (壓構積範繭艱艱襯繭襯, 築顧築簾製範廠淵艱鹹 ~ 顧壓遞夢構膚繭淵積選) 更多