A Study to Test the Effects of Centanafadine in Adults With Attention-deficit/Hyperactivity Disorder and Emotional Dysregulation
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
1 other identifier
interventional
80
1 country
16
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Sep 2026
Shorter than P25 for phase_3
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 6, 2026
CompletedFirst Posted
Study publicly available on registry
August 12, 2026
CompletedStudy Start
First participant enrolled
September 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 27, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 27, 2027
September 14, 2026
September 1, 2026
9 months
August 6, 2026
September 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline to Week 8 in the Wender-Reimherr Adult Attention Deficit Disorder Scale (WRAADDS) Total Score
Baseline up to Week 8
Secondary Outcomes (15)
Change From Baseline to Week 8 in the Wender-Reimherr Adult Attention Deficit Disorder Scale Emotional Dysregulation (WRAADDS-ED) Subscale Score
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
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
Baseline up to Week 8
Change From Baseline to Week 8 in the BRIEF-A T-score for the Behavioral Regulation Index (BRI) Scale
Baseline up to Week 8
Change From Baseline to Week 8 in the BRIEF-A T-score for the Metacognition Index (MI) Scale
Baseline up to Week 8
- +10 more secondary outcomes
Study Arms (1)
Centanafadine XR
EXPERIMENTALParticipants will receive centanafadine XR capsule 328.8 milligrams (mg), orally, QD, for 8 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- Primary diagnosis of ADHD per the Adult ADHD Clinical Diagnostic Scale (ACDS).
- Adult ADHD Investigator Symptom Rating Scale (AISRS) total score of ≥ 28 at baseline.
- Symptoms of ED as determined by the WRAADDS-ED subscale score ≥ 7 at baseline.
- CGI-S-ADHD rating ≥ 4 (at least moderate severity) at baseline.
You may not qualify if:
- 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.
- 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.
- 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.
- 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).
- 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).
- Current use of prohibited psychotropic medications that cannot be discontinued within 7 to 28 days prior to enrollment.
- Any disorder that is the primary focus of treatment other than ADHD.
- Evidence of current substance use disorder or history in the past 12 months.
- History of any prior exposure to centanafadine.
- 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.
- Have an allergy to the IMP or any component of the IMP.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Sarkis Clinical Trials - Gainesville
Gainesville, Florida, 32607, United States
CNS Healthcare - Jacksonville (Clinical Neuroscience Solutions - Jacksonville)
Jacksonville, Florida, 32256, United States
Accel Research Sites-Maitland
Maitland, Florida, 32751, United States
Nola Research Works
New Orleans, Louisiana, 70125, United States
Boston Clinical Trials
Boston, Massachusetts, 02132, United States
Adams Clinical - Watertown
Watertown, Massachusetts, 02472, United States
St. Charles Psychiatric Associates/Midwest Research Group
Saint Charles, Missouri, 63304, United States
Center for Psychiatry and Behavioral Medicine. Inc.
Las Vegas, Nevada, 89128, United States
Center for Emotional Fitness
Cherry Hill, New Jersey, 08002, United States
The Medical Research Network, LLC
New York, New York, 10128, United States
Patient Priority Clinical Trials
Cincinnati, Ohio, 45215, United States
Summit Research Network
Portland, Oregon, 97210, United States
Donald J. Garcia, Jr, MD, PA
Austin, Texas, 78737, United States
Houston Clinical Trials LLC
Bellaire, Texas, 77401, United States
Kaleidoscope Clinical Research
Houston, Texas, 77089, United States
Core Clinical Research
Everett, Washington, 98201, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 6, 2026
First Posted
August 12, 2026
Study Start
September 1, 2026
Primary Completion (Estimated)
May 27, 2027
Study Completion (Estimated)
May 27, 2027
Last Updated
September 14, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- 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.
- Access Criteria
- Otsuka will share data on the Vivli data sharing platform: https://vivli.org/ourmember/Otsuka/
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.