A Phase 3, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Hydrochloride Carliprazine Capsules or Aripiprazole Tablets for the Treatment of Acute Schizophrenia Subjects

This is a non-Inferiority trial to evaluate efficacy and safety of hydrochloride carliprazine capsules and aripiprazole tablets in treating acute schizophrenia in Chinese adults. 376 patients will be randomizdely assigned in a 1:1 ratio to treatment group and control group. All enrolled subjects will be orally administered with hydrochloride carliprazine capsules or aripiprazole tablets for 6 consecutive weeks.

开始日期2024-10-01

申办/合作机构

成都康弘药业集团股份有限公司

CTR20240938

/ Recruiting临床3期

一项评价盐酸卡利拉嗪胶囊用于治疗成人急性期精神分裂症的疗效和安全性的多中心、随机、双盲、双模拟、阳性对照III期临床试验

主要目的是评价浙江京新药业股份有限公司研制的盐酸卡利拉嗪胶囊1.5~6 mg/日剂量下治疗成人急性期精神分裂症患者的疗效。次要目的为评价浙江京新药业股份有限公司研制的盐酸卡利拉嗪胶囊1.5~6 mg/日剂量下治疗成人急性期精神分裂症患者的安全性。

开始日期2024-03-29

申办/合作机构

浙江京新药业股份有限公司

NCT06179108

/ Active, not recruiting临床2期

A Randomized, Double-blinded, Placebo-controlled, Multicenter Study to Evaluate the Antipsychotic Efficacy and Safety of LB-102 in the Treatment of Adult Patients With Acute Schizophrenia

This is a Phase 2, randomized, double-blind, placebo-controlled, multi-center inpatient study to evaluate the efficacy and safety of LB-102 in adult patients diagnosed with acutely exacerbated schizophrenia. To determine whether LB-102 administered to patients with acutely exacerbated schizophrenia demonstrates antipsychotic efficacy, as determined by a change from Baseline on the Positive and Negative Syndrome Scale (PANSS) total score, compared to placebo at 28 days. The secondary objectives of the study are to evaluate improvement in CGI-S, safety and tolerability, and pharmacokinetics.

开始日期2023-12-04

申办/合作机构

LB Pharmaceuticals, Inc.初创企业

100 项与急性精神分裂症相关的临床结果

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100 项与急性精神分裂症相关的转化医学

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项与急性精神分裂症相关的文献（医药）

2025-02-01·International Journal of Mental Health Nursing

How Do People With Schizophrenia Manage Their Daily Life? A Qualitative Study

Article

作者: Lemmens, Gilbert ; Costa, Ursula ; Van Hecke, Ann ; Wyckaert, Mariotte ; Van de Velde, Dominique ; De Vriendt, Patricia ; Satink, Ton ; Braeckman, Jolien

ABSTRACTDue to the rising number of long‐term mental health conditions, there has been a shift in therapeutic focus from curing these conditions, to living a meaningful life with them. Self‐management is described as the ability to live with the emotional, life role and medical consequences of long‐term conditions such as schizophrenia. However, the perspective of people with schizophrenia on self‐management in current literature is missing. A lack of understanding of strategies used by people with schizophrenia to self‐manage, could adversely affect the use of self‐management interventions. Therefore, this study aims to identify how people with schizophrenia manage their daily life. Semi‐structured interviews (n = 9) were conducted in a qualitative descriptive design. The study is reported by using the COREQ checklist. All participants, recruited through purposive sampling, have been stabilised after a schizophrenic episode and have been reintegrated into their community. The data were analysed through thematic analysis. Self‐management for people with schizophrenia is an individualised process that revolves around performing day‐to‐day activities according to the participant's wishes. In addition, participants tried to prevent relapse by self‐managing daily life. Personal‐, social‐ and schizophrenia‐related factors were seen as barriers and/or facilitators in their self‐management. These barriers and/or facilitators were self‐managed using daily activities. Current self‐management interventions for this population often aim at improving medication adherence. Self‐management interventions facilitated by health care professionals should (i) focus more on supporting patients in finding their daily structure through meaningful activities and (ii) be mindful of the duality contained within self‐management of people with stabilised schizophrenia.

2024-12-01·Neuropsychopharmacology Reports

Association between treatment response and dose of blonanserin transdermal patch in patients with acute schizophrenia: A post hoc cluster analysis based on baseline psychiatric symptoms

Article

作者: Yoshida, Kazumasa ; Koshikawa, Yosuke ; Kato, Masaki ; Masuda, Takahiro ; Takekita, Yoshiteru ; Matsumoto, Yuji

AbstractAimTo explore the optimal dose of blonanserin transdermal patch (BNS‐P) based on baseline psychiatric symptomatic characteristics during acute schizophrenia.MethodsA post hoc cluster analysis was conducted using data from a 6‐week randomized, double‐blind, placebo‐controlled study of BNS‐P (40 or 80 mg/day) in acute schizophrenia. We classified patients into three clusters based on baseline psychiatric symptoms. Efficacy was assessed using the change from baseline to week 6 in the PANSS total score. Safety was assessed by the incidence of adverse events.ResultsAmong 577 patients, three clusters were identified, characterized by severe psychiatric (Cluster‐S; n = 122), predominant negative (Cluster‐N; n = 191), and predominant positive (Cluster‐P; n = 264) symptoms. In Cluster‐P, both BNS‐P 40 and 80 mg/day reduced PANSS total score significantly more than placebo (p = 0.036, effect size = 0.342; p < 0.001, effect size = 0.687, respectively). In Cluster‐S and ‐N, only BNS‐P 80 mg/day reduced PANSS total score significantly more than placebo (p = 0.045, effect size = 0.497; p = 0.034, effect size = 0.393, respectively). The effect size was greater at 80 mg/day than at 40 mg/day across all clusters. The most common treatment‐emergent adverse events were akathisia and skin‐related adverse events in all clusters.ConclusionBNS‐P exhibited a dose‐dependent antipsychotic effect in all clusters, particularly highlighting its efficacy in patients with predominant positive symptoms, even at lower doses. These findings provide novel and valuable insights for determining BNS‐P dose tailoring to individual symptomatic characteristics in real‐world practice.

2024-12-01·Schizophrenia Research

Efficacy of KarXT on negative symptoms in acute schizophrenia: A post hoc analysis of pooled data from 3 trials

Article

作者: Targum, Steven D ; Yohn, Samantha E ; Marder, Stephen R. ; Brannan, Stephen K ; Brannan, Stephen K. ; Miller, Andrew C. ; Miller, Andrew C ; Targum, Steven D. ; Claxton, Amy ; Yohn, Samantha E. ; Horan, William P ; Marder, Stephen R ; Horan, William P. ; Kaul, Inder

BACKGROUNDCurrently approved antipsychotics do not adequately treat negative symptoms (NS), which are a major determinant of functional disability in schizophrenia. KarXT, an M₁ /M₄ preferring muscarinic receptor agonist, has shown efficacy as a broad-spectrum monotherapy for the treatment of schizophrenia in participants with acute psychosis. Post hoc analyses evaluated the possibility that NS improve independently of positive symptoms with KarXT in a subgroup of participants with moderate-to-severe NS and no predominance of positive symptoms.METHODSData were pooled from the three pivotal trials of KarXT monotherapy in people with schizophrenia with an acute exacerbation of psychosis. All 3 studies used similar 5-week randomized, double-blind, placebo-controlled designs (modified intention-to-treat sample N = 640). PANSS criteria proposed in the literature identified a subset of study participants (n = 64) with prominent NS.RESULTSKarXT was significantly better than placebo on PANSS Marder Negative Factor Scores in the full sample (p < .001; Cohen's d = 0.42) and more so in the prominent NS subgroup (p < .001; Cohen's d = 1.18). Further, the KarXT effect in the NS subgroup remained significant after accounting for changes in positive symptoms, depression/anxiety, disorganization, and hostility.CONCLUSIONSParticipants with prominent NS revealed greater improvement of NS following KarXT therapy than the full sample that persisted after accounting for positive and other symptoms. While these findings must be interpreted with caution, they are consistent with the possibility that NS improvements associated with KarXT are not secondary to improvements in other symptom domains and support further investigation in larger, stable outpatient studies.

项与急性精神分裂症相关的新闻（医药）

2025-01-13

·药研网

100亿美元！强生正在考虑收购CNS制药商Intra-Cellular

据彭博社报道，强生正在考虑收购CNS制药商Intra-Cellular Therapies。双方最早可能在本周达成协议。据估值，Intra-Cellular 的市值约为 100 亿美元。 Intra-Cellular Therapies成立于2002年，是一家专注于中枢神经系统（CNS）疾病疗法开发和商业化的生物制药公司，公司在2024年4月完成了5.75亿美元的公开募股，显示出其在资本市场上的强劲表现和未来发展潜力。 Intra-Cellular Therapies 的首款自主产品Caplyta，用于治疗急性精神分裂症。与2023年同期相比，Caplyta在2024年第三季度的销售额增长了39%，达到1.75亿美元。管线中进度较快的产品Lumateperone已提交监管审批，拟用于治疗双相情感障碍以及与痴呆症（包括阿尔茨海默病）相关的行为症状。 Intra-Cellular Therapies管线据悉，谈判仍处于早期阶段，尚未做出最终决定。消息人士称，谈判不能保证会达成正式协议，还可能出现其他潜在的收购者。周五，Intra-Cellular 股价飙升近15%，反映出投资者对潜在交易的预期。强生一直积极拓展高增长治疗领域，旨在在日益激烈的竞争中巩固其制药部门的增长。此次潜在收购可能有助于强生扩大其神经科学产品组合，并抵消其重磅药物专利到期带来的收入挑战。 End 声明：本公众号所有发文章(包括原创及转载文章)系出于传递更多信息之目的，且注明来源和作者。本公众号欢迎分享朋友圈或大群，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载/商务/投稿 | 联系微信15618157102（sum_Gmi）商务合作稿件征集点击了解详情往期回顾 1 10月 | 20家生物医药裁员汇总 2 国产首款四价HPV疫苗拟纳入优先审评 3 3. 7亿美元!今年规模最大的生物医药融资诞生

并购疫苗免疫疗法细胞疗法信使RNA

2025-01-09

·药明康德

显著改善疾病症状！潜在“first-in-class”小分子将迈入3期试验阶段

▎药明康德内容团队编辑今日，LB Pharmaceuticals宣布NOVA临床2期研究的积极顶线结果。分析显示，其在研口服小分子疗法LB-102达到主要终点。与安慰剂相比，所有剂量的LB-102可显著改善急性精神分裂症成年患者的精神分裂症阳性和阴性症状量表（PANSS）总分。根据此结果，该公司预计将LB-102推进至3期试验，并进一步探索该疗法在其他精神疾病适应症的潜力。 NOVA是一项随机、双盲、安慰剂对照、多中心的剂量探索试验，招募了359名年龄在18至55岁之间、符合《精神障碍诊断和统计手册》第五版（DSM-5）标准所评定的急性加重型精神分裂症的住院成人患者。分析显示，NOVA研究达到了主要终点，即在第4周时，患者的PANSS总评分较基线产生统计学显著下降： 50 mg剂量组（n=107）：与安慰剂相比，PANSS总评分减少5.0分（p=0.0009）。 75 mg剂量组（n=108）：与安慰剂相比，PANSS总评分减少4.7分（p=0.0022）。 100 mg探索性剂量组（n=36）：与安慰剂相比，PANSS总评分减少6.8分（p=0.0017）。图片来源：123RF LB-102总体安全且耐受性良好。受试者的锥体外系症状（EPS）发生率较低，与催乳素升高相关的临床不良事件有限，发生QT间期（QTcF）延长事件亦有限，这些不良事件通常与D2拮抗剂有关。 LB-102是一种每日一次的口服小分子疗法，正在开发为潜在“first-in-class”苯甲酰胺类抗精神病药物。LB-102针对精神分裂症的阳性症状和阴性症状，可能为疾病管理提供全面的治疗方案。 ▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料： [1] LB Pharmaceuticals Announces Positive Topline Results from Phase 2 Trial of LB-102 in Schizophrenia. Retrieved January 8, 2025 from https://www.globenewswire.com/news-release/2025/01/08/3006104/0/en/LB-Pharmaceuticals-Announces-Positive-Topline-Results-from-Phase-2-Trial-of-LB-102-in-Schizophrenia.html 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

临床结果临床3期临床2期

2024-12-11

·Business Wire

Adams Clinical Announces Expansion into Inpatient Psychiatry and Schizophrenia Clinical Trial Capabilities with Signing of Partnership with InSite Clinical Research

BOSTON--( BUSINESS WIRE )--Adams Clinical, LLC (“Adams”, or the “Company”), a leading Neuroscience-focused clinical trial site network announced today that it has agreed on terms of the intent to partner with InSite Clinical Research (“InSite”), a clinical trial site in the Dallas-Fort Worth metroplex with expertise in inpatient and outpatient clinical trials for psychiatric and neurologic illnesses, including Schizophrenia. In parallel with this partnership, Adams Clinical is expanding inpatient capabilities to its existing Watertown, MA and Bronx, NY sites. The Company expects both locations to begin screening inpatient participants in the first half of 2025, augmenting Adams’ market-leading capabilities in outpatient Psychiatry and Alzheimer’s Disease treatment and prevention trials. “InSite adds an important dimension to our business as it expands Adam’s disease area expertise and marks the Company’s entry into Texas,” said Nelson Rutrick, CEO of Adams Clinical. “Historically, Adams Clinical focused only on Depression, outpatient Psychiatry, and Alzheimer’s Disease. Dr. Shiwach and the entire InSite team are widely regarded by pharmaceutical and biotech industry sponsors as a leader in acute Schizophrenia, Bipolar Disorder and Substance Use Disorder research. Dr. Shiwach and InSite are well-known for their contributions in many successful clinical trials that have led to new drug approvals over the last 20 years.” Mehran Ahmed, Partner at InTandem Capital Partners, added, “InSite has developed a strong track record in finding participants in this growing therapeutic area and we are excited to partner with InSite to further enhance their capabilities.” “I am delighted to join the Adams Clinical network and bring opportunities for additional clinical trials to the diverse psychiatric and neurological patient population that we serve here in Texas,” said Dr. Raj Shiwach, Principal Investigator at InSite. “I look forward to sharing my clinical expertise to replicate our successful inpatient Schizophrenia trial delivery model in the Massachusetts and New York locations.” Dr. Steve Brannan, an industry veteran in Schizophrenia drug development who most recently led the clinical development and successful FDA submission of Cobenfy (xanomeline & trospium chloride, formerly known as KarXT) as Chief Medical Officer of Karuna Therapeutics, said, “Dr. Shiwach made a substantial enrollment contribution in our Phase 2 and 3 KarXT trials. There continues to be an enormous unmet need for effective new therapies for people living with Schizophrenia and other psychiatric illnesses. The many promising new treatments in development across industry will necessitate an increase in clinical research sites capable of conducting high-quality inpatient and outpatient Psychiatry trials for the foreseeable future. The acquisition of InSite and the establishment of inpatient units at the existing Boston and New York City locations underscores Adams Clinical’s strategic alignment with the needs and priorities of their pharmaceutical and biotech sponsor customers.” The partnership with InSite follows a series of strategic expansion steps Adams Clinical has undertaken in 2024, including doubling existing site capacity with the opening of new site locations in New York City with Davis Clinical in the Bronx and Berman Clinical in Harlem. Provident Healthcare Partners served as the exclusive financial advisor to InSite Clinical in this transaction. About Adams Clinical Adams Clinical is the preeminent site network for enrollment speed and data quality in clinical trials for diseases of the central nervous system, with clinical trial sites embedded in vibrant, diverse communities throughout the US. The Company’s depth of expertise, best-in-class technologies, and market-leading recruitment and retention to accelerate high-quality evidence generation and time-to-data for Pharmaceutical and Biotech companies, CROs and clinical trial participants. About InTandem Capital Partners InTandem Capital Partners is a private equity firm that invests in and helps accelerate the growth of select healthcare services companies. Its goal is to build excellent businesses of significant value working collaboratively with its management team partners. InTandem is solely focused on investing in businesses that align closely with the Healthcare Quintuple Aim – the simultaneous pursuit of enhanced patient experience, elevated provider experience, improved clinical outcomes, greater healthcare equity, and lower cost of care delivery. The firm is comprised of former business executives and experienced investors, and is uniquely qualified to provide strategic, acquisition and operating expertise to help companies significantly increase their value and their contribution to an improved healthcare system. InTandem provides active support to the management of its portfolio companies directly and leverages its network of industry executives to augment its capabilities. For further information, please visit: www.intandemcapital.com .

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