NCT07759154 · Otsuka Pharmaceutical Development & Commercialization, Inc.
A Study to Test the Effects of Centanafadine in Adults With Attention-deficit/Hyperactivity Disorder and Emotional Dysregulation
What this study is about
The primary purpose of this study is to evaluate the effectiveness of centanafadine once daily (QD) extended-release (XR) capsules in adults with attention-deficit/hyperactivity disorder (ADHD) and emotional dysregulation (ED).
View original scientific description
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).
Interventions
DRUG
Centanafadine XR
Oral capsules
Primary outcome measures
Change From Baseline to Week 8 in the Wender-Reimherr Adult Attention Deficit Disorder Scale (WRAADDS) Total Score
Time frame: Baseline up to Week 8
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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. Note: Other protocol-specified inclusion/exclusion criteria may apply.
Where
- Gainesville, Florida
- Jacksonville, Florida
- Maitland, Florida
- New Orleans, Louisiana
- Boston, Massachusetts
- Watertown, Massachusetts
- Saint Charles, Missouri
- Las Vegas, Nevada
- Cherry Hill, New Jersey
- New York, New York
- Cincinnati, Ohio
- Portland, Oregon
And 4 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 14, 2026 · Source of record for eligibility and locations