🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the USA / NCT07759154
Recruiting Phase 3

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

NCT07759154 · tracked via the Priya Life Science USA tracker
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Phase
Phase 3
Started
2026-09-01
Last updated
2026-09-14

Condition(s) studied

Attention-deficit/Hyperactivity DisorderEmotional Dysregulation

Investigational drug(s) / intervention(s)

Centanafadine XR

Centanafadine XR: Oral capsules

Study 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

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (16)

FacilityCityRegionStatus
Sarkis Clinical Trials - Gainesville Gainesville Florida Not Yet Recruiting
CNS Healthcare - Jacksonville (Clinical Neuroscience Solutions - Jacksonville) Jacksonville Florida Not Yet Recruiting
Accel Research Sites-Maitland Maitland Florida Not Yet Recruiting
Nola Research Works New Orleans Louisiana Recruiting
Boston Clinical Trials Boston Massachusetts Not Yet Recruiting
Adams Clinical - Watertown Watertown Massachusetts Not Yet Recruiting
St. Charles Psychiatric Associates/Midwest Research Group Saint Charles Missouri Not Yet Recruiting
Center for Psychiatry and Behavioral Medicine. Inc. Las Vegas Nevada Not Yet Recruiting
Center for Emotional Fitness Cherry Hill New Jersey Recruiting
The Medical Research Network, LLC New York New York Not Yet Recruiting
Patient Priority Clinical Trials Cincinnati Ohio Not Yet Recruiting
Summit Research Network Portland Oregon Recruiting
Donald J. Garcia, Jr, MD, PA Austin Texas Recruiting
Houston Clinical Trials LLC Bellaire Texas Recruiting
Kaleidoscope Clinical Research Houston Texas Not Yet Recruiting
Core Clinical Research Everett Washington Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07759154 on ClinicalTrials.gov ↗ ← All trials in the USA