更新于：2024-11-01

Premenstrual Dysphoric Disorder

经前焦虑症

更新于：2024-11-01

基本信息

别名

Disorder, Premenstrual Dysphoric、Dysphoric Disorder, Premenstrual、PMDD

+ [15]

简介

A condition in which a woman suffers from severe depression, irritability, and tension before MENSTRUATION. Premenstrual dysphoric disorder (PMDD) may involve a wide range of physical or emotional symptoms, which are more severe and debilitating than those seen with premenstrual syndrome (PMS), and which include at least one mood-related symptom. Symptoms usually stop when, or shortly after, menstruation begins.

关联

屈螺酮/炔雌醇/左甲柳叶酸钙

靶点

AR x ER x MR x PR

作用机制

AR拮抗剂 [+3]

在研机构

Bayer HealthCare Pharmaceuticals, Inc.

原研机构

Bayer HealthCare AG

在研适应症

寻常痤疮 [+3]

非在研适应症-

最高研发阶段批准上市

首次获批国家/地区

美国

首次获批日期2010-09-24

Drospirenone/Ethinyl Estradiol

屈螺酮/炔雌醇

靶点

AR x ER x MR x PR

作用机制

AR拮抗剂 [+3]

在研机构

原研机构

在研适应症

非在研适应症

最高研发阶段批准上市

首次获批国家/地区

美国

首次获批日期2001-05-11

Paroxetine Hydrochloride

盐酸帕罗西汀

靶点

SERT

作用机制

SERT抑制剂

在研机构

原研机构

在研适应症

非在研适应症

最高研发阶段批准上市

首次获批国家/地区

美国

首次获批日期1992-12-29

项与经前焦虑症相关的临床试验

NCT06496139 / Not yet recruitingN/AIIT

Emotion Regulation Based Internet-delivered Cognitive Behavioural Therapy for Premenstrual Dysphoric Disorder: A Randomised Controlled Trial

Premenstrual dysphoric disorder (PMDD) is a debilitating cyclic mental disorder affecting about 2-5% of women of reproductive age. PMDD is characterised by recurring emotional, behavioural, cognitive, and somatic symptoms that arise during the luteal (premenstrual) phase of the menstrual cycle and remit shortly after the onset of menses. Although pharmacological interventions are available, many women experience residual symptoms, discontinue treatment or refrain from them because of side effects. Therefore, non-pharmacological treatment options are needed.
Preliminary evidence suggests that internet-delivered cognitive behavioural therapy (ICBT) is a promising candidate, but further research is warranted. Also, there is room for treatment improvement. Specifically, it has been suggested that components targeting emotional and interpersonal dysregulation should be incorporated into CBT for PMDD. The current study aims to assess the effects of an ICBT intervention for PMDD incorporating skills training in emotion regulation and interpersonal effectiveness in a randomised controlled trial (RCT).

开始日期2024-11-01

申办/合作机构

University of Uppsala

[+2]

NCT06648382 / Not yet recruitingN/AIIT

Pilot Test of a Self-Directed Psychotherapy Program for Premenstrual Disorders

This study is testing a self-help mental health program that was designed to help people cope with the challenges of living with a premenstrual disorder. Individuals with a premenstrual disorder - either premenstrual dysphoric disorder or premenstrual exacerbation of depression - will track their daily symptoms for two menstrual cycles before they complete the program, throughout the two-cycle program, and for an additional two cycles after accessing the program. This will allow the research team to compare their symptoms before and after accessing the program.

开始日期2024-10-15

申办/合作机构

University of Regina

NCT06462391 / Not yet recruitingN/AIIT

Adapting and Piloting Acceptance and Commitment Therapy (ACT) for Severe Premenstrual Mood Symptoms: An Open-label Feasibility Study of ACT-PM

In the weeks prior to menstruation, many individuals experience mood and physical symptoms that negatively impact their quality of life and functioning. Approximately 5% of women and menstruating individuals have such severe symptoms that they meet criteria for Premenstrual Dysphoric Disorder (PMDD). Further, of those with underlying mood disorders (i.e., depression, bipolar disorder) about 60% have cyclical worsening of symptoms classified as premenstrual exacerbation (PME). Both PMDD and PME are associated with significant impairment, yet limited effective options exist to treat these conditions. In this project, the investigators will adapt and evaluate an Acceptance and Commitment Therapy (ACT) group for PMDD and PME, entitled ACT-Premenstrual (ACT-PM), delivered virtually to maximize accessibility. The investigators will examine whether ACT-PM is feasible to deliver and whether it is acceptable to group participants and those facilitating the group. The study will lay the groundwork for future research to determine if the group is effective. If effective, the intervention could be scaled up to improve quality of life and outcomes for individuals suffering from PMDD and PME.

开始日期2024-07-01

申办/合作机构

Women's College Hospital

100 项与经前焦虑症相关的临床结果

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100 项与经前焦虑症相关的转化医学

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0 项与经前焦虑症相关的专利（医药）

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1,475

项与经前焦虑症相关的文献（医药）

2025-01-01·Progress in Neuro-Psychopharmacology and Biological Psychiatry

White matter integrity upon progesterone antagonism in individuals with premenstrual dysphoric disorder: A randomized placebo-controlled diffusion tensor imaging study

Article

作者: Sundström-Poromaa, Inger ; Gu, Xuan ; Lanzenberger, Rupert ; Hahn, Andreas ; Comasco, Erika ; Kaltsouni, Elisavet ; Wikström, Johan

BACKGROUNDPremenstrual dysphoric disorder (PMDD) is a depressive disorder triggered by fluctuations of progesterone and estradiol during the luteal phase of the menstrual cycle. Selective progesterone receptor modulation (SPRM), while exerting an antagonistic effect on progesterone and maintaining estradiol on moderate levels, has shown beneficial effects on the mental symptoms of PMDD. Progesterone is also known for its neuroprotective effects, while synthetic progestins have been suggested to promote myelination. However, the impact of SPRM treatment on white matter microstructure is unexplored.METHODSDiffusion tensor imaging was employed to collect data on white matter integrity in patients with PMDD, before and after treatment with ulipristal acetate (an SPRM) or placebo, as part of a double-blind randomized controlled-trial. Tract based spatial statistics were performed to investigate SPRM treatment vs. placebo longitudinal effects on fractional anisotropy (FA), mean diffusivity (MD), radial diffusivity (RD), and axial diffusivity (AD), on the whole white matter skeleton.RESULTSVoxel-wise analyses indicated no change over time in any white matter microstructure metrics in individuals treated with SPRM versus placebo. Improvement in PMDD symptoms did not correlate with changes in white matter microstructure. In secondary, exploratory, cross-sectional comparisons during treatment, the SPRM group displayed lower FA and higher MD, RD, and AD than the placebo group in several tracts.CONCLUSIONThe main findings suggest that SPRM treatment did not impact white matter microstructure compared with placebo. However, secondary exploratory analyses yielded between-group differences after treatment, which call for further investigation on the tracts potentially impacted by progesterone antagonism.CLINICAL TRIAL REGISTRATIONEUDRA-CT 2016-001719-19; "Selective progesterone receptor modulators for treatment of premenstrual dysphoric disorder. A randomized, double-blind, placebo-controlled study."; https://www.clinicaltrialsregister.eu/ctr-search/trial/2016-001719-19/SE.

2025-01-01·Journal of Affective Disorders

Intermittent escitalopram treatment and reactive aggression in women with premenstrual irritability and anger: A crossover study

Article

作者: Gröndal, Maria ; Luke, Timothy J ; Eriksson, Elias ; Näslund, Jakob ; Englund, Christin ; Winblad, Stefan ; Ask, Karl

BACKGROUNDSelective serotonin reuptake inhibitors (SSRI) are the primary treatment for premenstrual mood symptoms and particularly effective in reducing reactive aggression in the forms of irritability and anger. The present study examined whether behavioral responses in laboratory measures of reactive aggression are influenced by medication with the SSRI escitalopram in women reporting high levels of premenstrual irritability/anger.METHODSParticipants (N = 34) rated the cardinal mood symptoms of premenstrual dysphoric disorder over three menstrual cycles. During the second and third cycles, participants received escitalopram (20 mg) or placebo in a single-blind, cross-over design. In the luteal phase of the intervention cycles, participants completed two aggression tasks: The Anger-Infused Ultimatum Game (AI-UG) and the Point Subtraction Aggression Paradigm (PSAP). Additionally, they rated expression and control of anger using the State-Trait Anger Expression Inventory-2 (STAXI-2) once in the luteal phase and once in the follicular phase.RESULTSWhile irritability/anger was reduced in the treatment (vs. placebo) cycle, no effect of escitalopram was detected in the PSAP. Escitalopram decreased reactive aggressive behavior in the AI-UG but only for a subset of participants who experienced a sharp premenstrual rise in outwardly expressed anger and/or did not experience a premenstrual rise in inwardly expressed anger.LIMITATIONSThe participants' symptoms were based on the severity of only premenstrual irritability/anger, limiting the generalizability to the broader group of PMDD patients.CONCLUSIONThe results suggest that the behavioral consequences of severe premenstrual irritability/anger are not easily captured by traditional measures of reactive aggression and underline the importance of considering individual differences in symptom expression.

2024-12-01·Behaviour Research and Therapy

Induced ruminative and mindful self-focus in daily life across the menstrual cycle in women with and without premenstrual dysphoric disorder

Article

作者: Nayman, Sibel ; Kuehner, Christine ; Grammatikos, Ioanna Franziska ; Reinhard, Iris ; Schricker, Isabelle Florence

Rumination and mindfulness are transdiagnostic risk and protective factors while their role in Premenstrual Dysphoric Disorder (PMDD) is unclear. Thus, we aimed to investigate the cycle-phase-specific effects of rumination and mindful self-focus on momentary mood and cognitions in women with and without PMDD. This study involved brief ambulatory inductions of ruminative and mindful self-focus along with ambulatory assessments of negative (NA) and positive affect (PA), and rumination, present-moment-awareness (PMA) and self-acceptance on two days during both the follicular and late luteal phase in women with and without PMDD (n = 60 each). Compared to healthy controls, women with PMDD showed stronger increases in PA in response to mindful self-focus inductions during the late luteal phase, whereas no such group differences were identified during the follicular phase. Independent of clinical status and cycle phase, induced ruminative self-focus immediately increased momentary NA and rumination and decreased PMA, whereas induced mindful self-focus inductions increased momentary self-acceptance. Overall, higher PA-reactivity toward mindful self-focusing during late luteal phase in women with PMDD points to the potential of cycle-phase-specific mindfulness interventions for PMDD. Irrespective of cycle phase, rumination and mindfulness appear to represent targets for brief prevention and intervention measures for both non-clinical and clinical groups.

项与经前焦虑症相关的新闻（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

2024-08-19

·Firstwordpharma

MindBio says microdosed psychedelic shows long-term benefit in depression

MindBio Therapeutics is the latest biotech to post evidence backing the use of psychedelics for behavioural disorders. According to the Australian biotech, the hallucinogenic lysergic acid diethylamide (LSD) continued to benefit patients with major depressive disorder (MDD) several months post-treatment. In the Phase IIa trial, 20 patients with MDD received a sub-hallucinogenic microdose of LSD every three days for eight weeks. At the end of the treatment period, about half of the patients experienced complete remission from depression, with a mean reduction on the Montgomery-Åsberg Depression Rating Scale of 14.1 points. On Monday, MindBio reported that the antidepressant effect of LSD was sustained three months after patients received the final dose, with an average 62.8% reduction in depressive symptoms. At-home dosingMindBio’s positive data comes during a tumultuous period for psychedelic frontrunner Lykos Therapeutics. The company’s midomafetamine (MDMA)-based treatment for post-traumatic stress disorder (PTSD) was rejected by the FDA earlier this month, and three articles discussing mid-stage data for the drug were retracted from the journal Psychopharmacology — culminating in a 75% reduction in workforce announced last week. While Lykos’ experimental treatment was given in conjunction with psychotherapy at a care facility, MindBio has created a microdose formulation of LSD, dubbed MB22001, intended to be self-administered at home. According to the firm, other psychedelics in clinical testing are given at hallucinogenic doses and require in-patient supervision for six to eight hours, while microdosing could offer a more scalable, effective, and affordable way to treat patients with MDD.MindBio launched an 80-patient Phase IIb study of LSD for MDD in March, and is also exploring the psychedelic to treat premenstrual syndrome and premenstrual dysphoric disorder.

临床2期临床结果

2024-07-10

·Pharmaceutical Technology

Vistagen secures new patents for PH80 migraine treatment

Vistagen is developing PH80 as a hormone-free option for managing women’s health issues. Credit: sbw18/Shutterstock. Vistagen has expanded its global intellectual property (IP) portfolio with the receipt of multiple new patents for its PH80, a neuroactive pherine nasal spray developed for the treatment of migraine. The company has previously received patents in the US and from the European Patent Office . The patents are expected to be in force until 2040, subject to extensions. The new patents have been granted by IP Australia, the Hong Kong Intellectual Property Department, the Japan Patent Office and the Mexican Institute of Industrial Property. In Australia, the company’s PH80 secured a Notice of Allowance. It obtained Patent No 40068177 in Hongkong, and Patent No 7476229 in Japan. PH80 also secured notice of allowance in Mexico. See Also: Hong Kong approves Leqembi for Alzheimer’s treatment Rgenta Therapeutics’ RGT-61159 gains IND approval to treat cancers PH80 has a unique mechanism of action that targets neurocircuitry without requiring systemic absorption or direct neuronal activity in the brain. Vistagen is developing the spray as a hormone-free option for managing women’s health issues including vasomotor symptoms associated with menopause, premenstrual dysphoric disorder, dysmenorrhea and migraine. Pherines represent a new class of compounds aimed at treating psychiatric and neurological disorders through neurocircuitry-focused mechanisms. The neuroscience-focused biopharmaceutical company is engaged in the development and commercialisation of therapies for psychiatric and neurological disorders. Its pherine drug candidates have demonstrated favourable safety profiles in all studies completed. In 2023 the company obtained a Notice of Allowance from the Canadian IP Office for a patent related to the use of AV-101 in Parkinson’s disease (PD) patients. The treatment reduces the sudden uncontrolled movements, or dyskinesia, caused by using the PD medication levodopa. https://www.shutterstock.com/image-photo/senior-woman-using-cpap-machine-stop-737747287