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NCT07759154PHASE3Recruiting

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

Otsuka Pharmaceutical Development & Commercialization, Inc.

Start Date

9/1/2026

Completion Date

5/27/2027

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).

Eligibility Criteria

Age Range: 18 years to 65 years

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.

Interventions

DRUG

Centanafadine XR

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Conditions

Attention-deficit/Hyperactivity DisorderEmotional Dysregulation

Locations

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