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Can a Once-Daily pill tame ADHD and emotional storms?

NCT ID NCT07759154

Disease control Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 12, 2026 · Last updated Sep 15, 2026 · Updated 3 times

Summary

This trial is testing whether an experimental medication called centanafadine, taken once daily as extended-release capsules, can help adults with attention-deficit/hyperactivity disorder (ADHD) who also experience emotional dysregulation—difficulty managing emotions like irritability or mood swings. About 80 adults with a confirmed ADHD diagnosis and significant emotional symptoms will receive the drug for 8 weeks. Researchers will measure changes in ADHD symptoms and emotional control using standardized rating scales to see if the treatment offers meaningful improvement.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
centanafadine extended-release capsules
What this could lead to
If successful, this could offer a new daily medication option for adults with ADHD who also struggle with emotional control, potentially improving both focus and mood stability.
What could go wrong
This is an early-phase, open-label study without a placebo group, so results may be influenced by expectations. The drug may not prove more effective than existing treatments, and side effects are still being evaluated.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2026

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

attention deficit hyperactivity disorder, inattentive type attention deficit-hyperactivity disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Attention deficit hyperactivity disorder Emotional dysregulation

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    16 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Accel Research Sites-Maitland

    NOT_YET_RECRUITING

    Maitland, Florida, 32751, United States

  • Adams Clinical - Watertown

    NOT_YET_RECRUITING

    Watertown, Massachusetts, 02472, United States

  • Boston Clinical Trials

    NOT_YET_RECRUITING

    Boston, Massachusetts, 02132, United States

  • CNS Healthcare - Jacksonville (Clinical Neuroscience Solutions - Jacksonville)

    NOT_YET_RECRUITING

    Jacksonville, Florida, 32256, United States

  • Center for Emotional Fitness

    RECRUITING

    Cherry Hill, New Jersey, 08002, United States

  • Center for Psychiatry and Behavioral Medicine. Inc.

    NOT_YET_RECRUITING

    Las Vegas, Nevada, 89128, United States

  • Core Clinical Research

    NOT_YET_RECRUITING

    Everett, Washington, 98201, United States

  • Donald J. Garcia, Jr, MD, PA

    RECRUITING

    Austin, Texas, 78737, United States

  • Houston Clinical Trials LLC

    RECRUITING

    Bellaire, Texas, 77401, United States

  • Kaleidoscope Clinical Research

    NOT_YET_RECRUITING

    Houston, Texas, 77089, United States

  • Nola Research Works

    RECRUITING

    New Orleans, Louisiana, 70125, United States

  • Patient Priority Clinical Trials

    NOT_YET_RECRUITING

    Cincinnati, Ohio, 45215, United States

  • Sarkis Clinical Trials - Gainesville

    NOT_YET_RECRUITING

    Gainesville, Florida, 32607, United States

  • St. Charles Psychiatric Associates/Midwest Research Group

    NOT_YET_RECRUITING

    Saint Charles, Missouri, 63304, United States

  • Summit Research Network

    RECRUITING

    Portland, Oregon, 97210, United States

  • The Medical Research Network, LLC

    NOT_YET_RECRUITING

    New York, New York, 10128, United States

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