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

NCT ID: NCT07759154
Registry status: Recruiting
Study type: Interventional
Phase: Phase 3
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions: Attention-deficit/Hyperactivity Disorder, Emotional Dysregulation

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: 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

Enrollment: 80 participants (Estimated).

What is being studied

Intervention: 1-(naphthalen-2-yl)-3-azabicyclo(3.1.0)hexane
Drug: Centanafadine XR

Who may be eligible

Ages: 18 Years to 65 Years
Sex: All
Healthy volunteers accepted: No

ClinicalTrials.gov lists the following eligibility criteria.

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.

Study locations

16 study locations are listed.

Recruiting site status is explicitly provided for 16 locations; 5 are listed as Recruiting.

Countries: United States

Florida, United States: 3
Louisiana, United States: 1
Massachusetts, United States: 2
Missouri, United States: 1
Nevada, United States: 1
New Jersey, United States: 1
New York, United States: 1
Ohio, United States: 1
Oregon, United States: 1
Texas, United States: 3
Washington, United States: 1

Sample of listed locations

Nola Research Works — New Orleans, Louisiana, 70125, United States — Recruiting
Center for Emotional Fitness — Cherry Hill, New Jersey, 08002, United States — Recruiting
Summit Research Network — Portland, Oregon, 97210, United States — Recruiting
Donald J. Garcia, Jr, MD, PA — Austin, Texas, 78737, United States — Recruiting
Houston Clinical Trials LLC — Bellaire, Texas, 77401, United States — Recruiting
Sarkis Clinical Trials - Gainesville — Gainesville, Florida, 32607, United States — Not yet recruiting
CNS Healthcare - Jacksonville (Clinical Neuroscience Solutions - Jacksonville) — Jacksonville, Florida, 32256, United States — Not yet recruiting
Accel Research Sites-Maitland — Maitland, Florida, 32751, United States — Not yet recruiting
Boston Clinical Trials — Boston, Massachusetts, 02132, United States — Not yet recruiting
Adams Clinical - Watertown — Watertown, Massachusetts, 02472, United States — Not yet recruiting
St. Charles Psychiatric Associates/Midwest Research Group — Saint Charles, Missouri, 63304, United States — Not yet recruiting
Center for Psychiatry and Behavioral Medicine. Inc. — Las Vegas, Nevada, 89128, United States — Not yet recruiting
The Medical Research Network, LLC — New York, New York, 10128, United States — Not yet recruiting
Patient Priority Clinical Trials — Cincinnati, Ohio, 45215, United States — Not yet recruiting
Kaleidoscope Clinical Research — Houston, Texas, 77089, United States — Not yet recruiting
Core Clinical Research — Everett, Washington, 98201, United States — Not yet recruiting

Study details

Start date: September 1, 2026
Primary completion date: May 27, 2027
Completion date: May 27, 2027
First posted: August 12, 2026

Source and update information

Source: ClinicalTrials.gov
NCT ID: NCT07759154
Registry last updated: September 14, 2026
QualifiedStudies registry data refreshed: September 28, 2026
QualifiedStudies record fetched: September 28, 2026

View NCT07759154 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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