RecruitingPhase 3interventionalRules rewrite

Phase 3: testing Centanafadine XR for Attention-deficit/Hyperactivity Disorder

The primary purpose of this study is to measure the how well it works of centanafadine once daily (QD) extended-release (XR) capsules in adults with attention-deficit/hyperactivity disorder (ADHD) and emotional dysregulation (ED).

Official registry: https://clinicaltrials.gov/study/NCT07759154 · Otsuka Pharmaceutical Development & Commercialization, Inc. · enrollment listed as 80

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Centanafadine XR. The registry lists allocation as na. The primary purpose of this study is to measure the how well it works of centanafadine once daily (QD) extended-release (XR) capsules in adults with attention-deficit/hyperactivity disorder (ADHD) and emotional dysregulation (ED).

They plan to enroll about 80 people at 16 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: Centanafadine XR

Primary outcome (registry wording): Change From Baseline to Week 8 in the Wender-Reimherr Adult Attention Deficit Disorder Scale (WRAADDS) Total Score

Who it is for (from inclusion criteria)

Ages 18 Years to 65 Years
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

Who the registry excludes

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
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)
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 treatment clinical trials involving investigational drugs within the past year

Public study contact (from the registry)

Otsuka Call Center

844-687-8522

otsuka-professionalservices@otsuka-us.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

16 listed

Sarkis Clinical Trials - Gainesville — Gainesville, Florida (recruiting)
CNS Healthcare - Jacksonville (Clinical Neuroscience Solutions - Jacksonville) — Jacksonville, Florida (recruiting)
Accel Research Sites-Maitland — Maitland, Florida (recruiting)
Nola Research Works — New Orleans, Louisiana (recruiting)
Boston Clinical Trials — Boston, Massachusetts (recruiting)
Adams Clinical - Watertown — Watertown, Massachusetts (recruiting)
St. Charles Psychiatric Associates/Midwest Research Group — Saint Charles, Missouri (recruiting)
Center for Psychiatry and Behavioral Medicine. Inc. — Las Vegas, Nevada (recruiting)
Center for Emotional Fitness — Cherry Hill, New Jersey (recruiting)
The Medical Research Network, LLC — New York, New York (recruiting)
Patient Priority Clinical Trials — Cincinnati, Ohio (recruiting)
Summit Research Network — Portland, Oregon (recruiting)

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FAQ about this NCT record

Is NCT07759154 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07759154?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07759154?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary