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A Study to Test the Effects of Centanafadine in Adults With Attention-deficit/Hyperactivity Disorder and Emotional Dysregulation

2026年9月9日 更新者：Otsuka Pharmaceutical Development & Commercialization, Inc.

A Phase 3b, Multicenter, Open-label, Single-arm Trial to Evaluate the Efficacy and Safety of Orally Administered Centanafadine QD XR Capsules in Adults With Attention-deficit/Hyperactivity Disorder and Emotional Dysregulation

The primary purpose of this study is to evaluate the efficacy of centanafadine once daily (QD) extended-release (XR) capsules in adults with attention-deficit/hyperactivity disorder (ADHD) and emotional dysregulation (ED).

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

80

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 美国
    • Florida
      • Gainesville、Florida、美国、32607
      • Jacksonville、Florida、美国、32256
        • 尚未招聘
        • CNS Healthcare - Jacksonville (Clinical Neuroscience Solutions - Jacksonville)
        • 首席研究员：
          • Jones
        • 接触：
      • Maitland、Florida、美国、32751
    • Louisiana
      • New Orleans、Louisiana、美国、70125
    • Massachusetts
      • Boston、Massachusetts、美国、02132
      • Watertown、Massachusetts、美国、02472
    • Missouri
      • Saint Charles、Missouri、美国、63304
        • 尚未招聘
        • St. Charles Psychiatric Associates/Midwest Research Group
        • 接触：
        • 首席研究员：
          • Mattingly
    • Nevada
      • Las Vegas、Nevada、美国、89128
    • New Jersey
      • Cherry Hill、New Jersey、美国、08002
    • New York
      • New York、New York、美国、10128
    • Ohio
      • Cincinnati、Ohio、美国、45215
    • Oregon
    • Texas
      • Austin、Texas、美国、78737
      • Bellaire、Texas、美国、77401
      • Houston、Texas、美国、77089
    • Washington
      • Everett、Washington、美国、98201

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria

  1. Primary diagnosis of ADHD per the Adult ADHD Clinical Diagnostic Scale (ACDS).
  2. Adult ADHD Investigator Symptom Rating Scale (AISRS) total score of ≥ 28 at baseline.
  3. Symptoms of ED as determined by the WRAADDS-ED subscale score ≥ 7 at baseline.
  4. CGI-S-ADHD rating ≥ 4 (at least moderate severity) at baseline.

Exclusion Criteria

  1. Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for a lifetime diagnosis of bipolar and related disorders, schizophrenia spectrum and other psychotic disorders, borderline and antisocial personality disorders, neurocognitive disorders, autism spectrum disorder, or intellectual disability.
  2. DSM-5 criteria for a current diagnosis of major depressive disorder, post-traumatic stress disorder, any substance use disorder, untreated/unstable obstructive sleep apnea, eating disorders, or obsessive compulsive disorder.
  3. Any other current DSM-5 comorbid psychiatric disorder identified by the Mini International Neuropsychiatric Interview (MINI) or any medical condition that, in the judgment of the investigator, could be expected to require treatment with medications prohibited in this trial that cannot be safely discontinued with completion of an appropriate washout, could confound efficacy or safety assessments, or be the primary driver of ED.
  4. Presence of an unstable or uncontrolled medical condition that, in the opinion of the investigator, could pose a safety risk to the participant or could manifest with psychiatric symptoms (eg, thyroid disease).
  5. In the clinical opinion of the investigator, the participant has not derived significant therapeutic benefit from 2 or more ADHD therapies of 2 different classes (eg, amphetamine and methylphenidate, or amphetamine and atomoxetine) given with an acceptable dose and duration during adulthood (aged 18 years or older).
  6. Current use of prohibited psychotropic medications that cannot be discontinued within 7 to 28 days prior to enrollment.
  7. Any disorder that is the primary focus of treatment other than ADHD.
  8. Evidence of current substance use disorder or history in the past 12 months.
  9. History of any prior exposure to centanafadine.
  10. Participated in other clinical trials involving investigational drugs within 180 days prior to screening or participated in more than 2 interventional clinical trials involving investigational drugs within the past year.
  11. Have an allergy to the IMP or any component of the IMP.

Note: Other protocol-specified inclusion/exclusion criteria may apply.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Centanafadine XR
Participants will receive centanafadine XR capsule 328.8 milligrams (mg), orally, QD, for 8 weeks.
药品：Centanafadine XR
Oral capsules
其他名称：
  • EB-1020

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Change From Baseline to Week 8 in the Wender-Reimherr Adult Attention Deficit Disorder Scale (WRAADDS) Total Score
大体时间：Baseline up to Week 8
Baseline up to Week 8

次要结果测量

结果测量
大体时间
Change From Baseline to Week 8 in the Wender-Reimherr Adult Attention Deficit Disorder Scale Emotional Dysregulation (WRAADDS-ED) Subscale Score
大体时间：Baseline up to Week 8
Baseline up to Week 8
Change From Baseline to Week 8 in the Clinical Global Impressions-Severity Scale for Attention-Deficit/Hyperactivity Disorder (CGI-S-ADHD) Score
大体时间：Baseline up to Week 8
Baseline up to Week 8
Change From Baseline to Week 8 in the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) T-score for the Global Executive Composite (GEC) Scale
大体时间：Baseline up to Week 8
Baseline up to Week 8
Change From Baseline to Week 8 in the BRIEF-A T-score for the Behavioral Regulation Index (BRI) Scale
大体时间：Baseline up to Week 8
Baseline up to Week 8
Change From Baseline to Week 8 in the BRIEF-A T-score for the Metacognition Index (MI) Scale
大体时间：Baseline up to Week 8
Baseline up to Week 8
Change From Baseline to Week 8 in the Difficulties in Emotion Regulation Scale (DERS) Total Score
大体时间：Baseline up to Week 8
Baseline up to Week 8
Change From Baseline to Week 8 in the Nonacceptance of Emotional Responses (NONACCEPT) DERS Subscale Score
大体时间：Baseline up to Week 8
Baseline up to Week 8
Change From Baseline to Week 8 in the Difficulties Engaging in Goal-Directed Behavior (GOALS) DERS Subscale Score
大体时间：Baseline up to Week 8
Baseline up to Week 8
Change From Baseline to Week 8 in the Impulse Control Difficulties (IMPULSE) DERS Subscale Score
大体时间：Baseline up to Week 8
Baseline up to Week 8
Change From Baseline to Week 8 in the Lack of Emotional Awareness (AWARE) DERS Subscale Score
大体时间：Baseline up to Week 8
Baseline up to Week 8
Change From Baseline to Week 8 in the Limited Access to Emotion Regulation Strategies (STRATEGIES) DERS Subscale Score
大体时间：Baseline up to Week 8
Baseline up to Week 8
Change From Baseline to Week 8 in the Lack of Emotional Clarity (CLARITY) DERS Subscale Score
大体时间：Baseline up to Week 8
Baseline up to Week 8
Change From Baseline to Week 8 in the Attention-Deficit/Hyperactivity Disorder Symptoms, Executive Function Deficits, and Emotional Dyscontrol as Assessed by the Adult ADHD Self-Report Scale (ASRS) Score
大体时间：Baseline up to Week 8
Baseline up to Week 8
Number of Participants With Adverse Events
大体时间：Up to Week 9
Up to Week 9
Number of Participants With Suicidal Ideation or Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
大体时间：Up to Week 9
Up to Week 9

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Otsuka Pharmaceutical Development & Commercialization, Inc.

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年9月1日

初级完成 (估计的)

2027年5月27日

研究完成 (估计的)

2027年5月27日

研究注册日期

首次提交

2026年8月6日

首先提交符合 QC 标准的

2026年8月6日

首次发布 (实际的)

2026年8月12日

研究记录更新

最后更新发布 (实际的)

2026年9月14日

上次提交的符合 QC 标准的更新

2026年9月9日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 405-201-00231

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

Anonymized individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.

IPD 共享时间框架

Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.

IPD 共享访问标准

Otsuka will share data on the Vivli data sharing platform: https://vivli.org/ourmember/Otsuka/

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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