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New pill aims to tame both ADHD and anxiety in one daily dose

NCT ID NCT06973577

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 3 trial tested a once-daily extended-release capsule called centanafadine in 315 adults with both ADHD and anxiety (generalized or social anxiety). For 8 weeks, participants received either the drug or a placebo. The study measured changes in ADHD symptoms using a clinician rating scale and also tracked anxiety levels. The goal was to see if centanafadine can safely improve both conditions together.

What this could mean

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

Active substance
centanafadine (once-daily extended-release capsule)
What this could lead to
If it works, this could offer a new once-daily medication option for adults with both ADHD and anxiety, potentially improving attention and reducing anxiety symptoms.
What could go wrong
This is a completed Phase 3 trial, but results are not yet published. The 8-week duration is short, and long-term safety or effectiveness is unknown. Side effects or lack of benefit over placebo are possible.

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

315 people

The number who actually took part.

Started

Mar 2025

Finished

Apr 2026

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. Participants between 18 and 65 years of age, inclusive. 2. Diagnosis of ADHD per the DSM-5-TR criteria and confirmed using the ACDS Version 1.2 at screening. 3. AISRS total score of ≥ 28 at baseline. 4. Diagnosis of GAD and/or SAD per DSM-5-TR criteria and confirmed using the MINI at screening. 5. HAM-A total score ≥ 20 at baseline. 6. CGI-S-ADHD and CGI-S-anxiety rating ≥ 4 at baseline. 7. Body mass index from 18.0 to 40.0 kg/m2 (inclusive). 8. Ability to provide written, informed consent prior to initiation of any trial-related procedures, and ability, in the opinion of the principal investigator, to comply with all the requirements of the trial. Exclusion Criteria: 1. In the clinical opinion of the investigator, participant has not derived 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). 2. In the clinical opinion of the investigator, participant has not derived therapeutic benefit from 2 or more anxiety therapies of 2 different classes (eg, selegiline and duloxetine, or buspirone and lorazepam) given with an acceptable dose and duration during adulthood (aged 18 years or older). 3. Current use of prohibited psychotropic medications that cannot be discontinued 2 weeks prior to randomization. Fluoxetine is prohibited within 28 days of randomization. 4. Participants who have started individual or group psychotherapy within the past 3 months prior to screening (ongoing psychotherapy that is not expected to change in frequency or type during the trial is permissible). 5. Any disorder that is the primary focus of treatment other than ADHD. 6. Participants with lifetime DSM-5-TR diagnosis of neurocognitive disorder, schizophrenia or any psychotic disorder, bipolar disorder, autism spectrum disorder, or personality disorders. Participants with current diagnosis of post-traumatic stress disorder, obsessive compulsive disorder, any substance use disorder, eating disorders, major depressive disorder; or other anxiety disorders such as panic disorder, agoraphobia, separation anxiety disorder, selective mutism, substance or medication induced anxiety, or due to medical condition, or specific phobia will be excluded. 7. Participant is, in the investigator's judgment, at significant risk for suicide. A participant with a Columbia-Suicide Severity Rating Scale (C-SSRS) ideation score of 4 or 5 within the last 6 months or participants who answer "Yes" on any of the 5 C-SSRS Suicidal Behavior Items (actual attempt, interrupted attempt, aborted attempt, preparatory acts, or behavior) within the past year must be excluded. 8. Participants with a positive UDS for illicit drugs at screening or baseline. Participants with a positive drug test at screening for ADHD or anxiety medications including methylphenidate, or amphetamines, may continue while undergoing the required washout. Participants with a positive drug test at baseline for ADHD or anxiety medications are excluded. A positive drug test at baseline for drugs of abuse, including cannabis, unless all of the following cannabis specific conditions are met: 1. No DSM-5-TR diagnosis of cannabis use disorder within the past 12 months; 2. If per investigator's judgement, cannabis use will not compromise safety, efficacy assessments or protocol compliance. 3. Participant agrees to maintain their consistent use pattern throughout the trial 4. Participant agrees to refrain from cannabis use within 12 hours of trial visits. 9. Participants with evidence of current substance use disorder or history in the past 12 months. 10. Participants with epilepsy, a history of epilepsy, or a history of seizure, except for a single childhood febrile seizure, a single seizure post brain injury, or a single seizure due to alcohol withdrawal. 11. Participants who are partially hospitalized or receiving inpatient care or have any other medical or physical condition(s) that, in the opinion of the investigator, may prevent the participant from completing the trial or would go against the participant's best interest with participation in the trial. This would include any significant illness or unstable medical condition that could lead to difficulty complying with the protocol. This would also include most bariatric surgeries, with the only exception being those where there has been no breach of the gastrointestinal wall (ie, uncomplicated lap band surgery) AND no sign of malabsorption. 12. The following laboratory test and ECG results are exclusionary at screening: 1. Platelets ≤ 75,000/mm3 2. Hemoglobin ≤ 9 g/dL 3. Neutrophils, absolute ≤ 1000/mm3 4. AST \> 2 × upper limit of normal 5. ALT \> 2 × upper limit of normal 6. Creatinine ≥ 2 mg/dL 7. HbA1c ≥ 7% 8. QTcF ≥ 450 msec for males or ≥ 470 msec for females 9. Abnormal free thyroxin (T4), unless discussed with and approved by the medical monitor (Note: free T4 is measured only if result for thyroid stimulating hormone \[TSH\] is abnormal) 13. Participants presenting with, or having a history of, uncontrolled hypertension (systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 95 mmHg) or symptomatic hypotension, or orthostatic hypotension which is defined as a decrease of ≥ 30 mmHg in systolic blood pressure or a decrease of ≥ 20 mmHg in diastolic blood pressure after at least 3 minutes standing compared with the previous supine blood pressure, or development of symptoms. 14. Participants with a history of any prior exposure to centanafadine. 15. Participants who have participated in other clinical trials involving investigational drugs within 180 days prior to screening or who have participated in more than 2 interventional clinical trials involving investigational drugs within the past year. 16. Participants of childbearing potential who are breast-feeding and/or have a positive pregnancy test result prior to receiving IMP. 17. Participants of reproductive potential / POCBP who do not agree to practice 2 different effective and/or highly effective methods of birth control or remain fully abstinent from sexual activity with the potential for conception, per the guidelines in Section 10.3. 18. Participants who do not agree to refrain from donating sperm or eggs from trial screening through 90 days for sperm and 30 days for eggs after the last dose of IMP. 19. Participants who have an allergy to the IMP or any component of the IMP.

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Conditions

The condition(s) this trial relates to.

anxiety anxiety disorder attention deficit hyperactivity disorder, inattentive type attention deficit-hyperactivity disorder generalized anxiety disorder social phobia

As listed by the trial registrant

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

ADHD Anxiety Generalized anxiety Social anxiety disorder

Contacts and locations

Locations

  • Clinical Research Center #008 - Long Beach Clinical Trial Services Inc.

    Long Beach, California, 90806, United States

  • Clinical Research Center #022 - Boston Clinical Trials - Alcanza Clinical Research, LLC

    Boston, Massachusetts, 02132, United States

  • Clinical Research Center #031 - Center for Emotional Fitness

    Cherry Hill, New Jersey, 08002, United States

  • Clinical Research Center #032 - CenExel iResearch, LLC

    Savannah, Georgia, 31405, United States

  • Clinical Research Center #033 - Woodland International Research Group

    Little Rock, Arkansas, 72211, United States

  • Clinical Research Center #034 - Coastal Carolina Research Center

    North Charleston, South Carolina, 29405, United States

  • Clinical Research Center #035 - Sarkis Clinical Trials

    Gainesville, Florida, 32607-2053, United States

  • Clinical Research Center #042 - Anderson Clinical Research

    Redlands, California, 92374, United States

  • Clinical Research Center #048 - Woodland Research Northwest

    Rogers, Arkansas, 72758, United States

  • Clinical Research Center #056 - Research Works INC.

    New Orleans, Louisiana, 70125, United States

  • Clinical Research Center #059 - Adams Clinical Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

  • Clinical Research Center #062 - Research Works - San Juan

    Guaynabo, PR, 00966, Puerto Rico

  • Clinical Research Site # 027 - Copley Clinical

    Boston, Massachusetts, 02116, United States

  • Clinical Research Site # 029 - Lehigh Center for Clinical Research

    Allentown, Pennsylvania, 18103, United States

  • Clinical Research Site #001 - CNS Healthcare - Memphis

    Memphis, Tennessee, 38119, United States

  • Clinical Research Site #002 - Psych Atlanta, PC

    Marietta, Georgia, 30060, United States

  • Clinical Research Site #003 - FutureSearch Trials of Dallas LP

    Dallas, Texas, 75251, United States

  • Clinical Research Site #004 - CenExel iResearch, LLC

    Decatur, Georgia, 30030, United States

  • Clinical Research Site #005 - Clinical Neuroscience Solutions, Inc.

    Jacksonville, Florida, 32256, United States

  • Clinical Research Site #006 - CNS Healthcare Orlando

    Orlando, Florida, 32801, United States

  • Clinical Research Site #008 - Long Beach Clinical Trial Services Inc.

    Long Beach, California, 90806, United States

  • Clinical Research Site #009 - Paradigm Research Professionals LLC

    Oklahoma City, Oklahoma, 73116, United States

  • Clinical Research Site #010 - Meridien Research/Accel Clinical

    Maitland, Florida, 32751, United States

  • Clinical Research Site #011 - NRC Research Institute

    Orange, California, 92868, United States

  • Clinical Research Site #012 - Clinical Trials of Texas

    San Antonio, Texas, 78229, United States

  • Clinical Research Site #013 - Donald J. Garcia, Jr. MD., PA

    Austin, Texas, 78737, United States

  • Clinical Research Site #014 - Suburban Research Associates

    Media, Pennsylvania, 19063, United States

  • Clinical Research Site #015 - Medical Research Group of Central Florida

    Orange City, Florida, 32763, United States

  • Clinical Research Site #016 - Clinical Research of Southern Nevada, LLC

    Las Vegas, Nevada, 89128, United States

  • Clinical Research Site #017 - Harmonex Neuroscience Research

    Dothan, Alabama, 36303, United States

  • Clinical Research Site #019 - Segal Trials Innovatice Clinical Research, Inc.

    Tamarac, Florida, 33319, United States

  • Clinical Research Site #020 - Houston Clinical Trials LLC

    Bellaire, Texas, 77401, United States

  • Clinical Research Site #021 - The Medical Research Network, LLC

    New York, New York, 10128, United States

  • Clinical Research Site #023 - Summit Headlands LLC

    Portland, Oregon, 97210, United States

  • Clinical Research Site #024 - Core Clinical Research

    Everett, Washington, 98201, United States

  • Clinical Research Site #025 - Adams Clinical

    Watertown, Massachusetts, 02472, United States

  • Clinical Research Site #026 - Neurobehavioral Research Inc

    Cedarhurst, New York, 11516, United States

  • Clinical Research Site #028 - Patient Priority Clinical Sites LLC

    Cincinnati, Ohio, 45215, United States

  • Clinical Research Site #030 - MCB Clinical Research Centers

    Colorado Springs, Colorado, 80910, United States

  • Clinical Research Site #036 - Grayline Research Center

    Wichita Falls, Texas, 76309, United States

  • Clinical Research Site #037 - Cenexel CIT IE (Clinical Innovations Inc)

    Riverside, California, 92506, United States

  • Clinical Research Site #038 - Sunwise Clinical Research

    Walnut Creek, California, 94596, United States

  • Clinical Research Site #039 - California Neuroscience Research, LLC

    Sherman Oaks, California, 91403, United States

  • Clinical Research Site #045 - Research Center for Clinical Studies

    Norwalk, Connecticut, 06851-4903, United States

  • Clinical Research Site #046 - ARSN-Largo CRU

    Largo, Florida, 33777, United States

  • Clinical Research Site #047 - Insight Clinical Trials

    Independence, Ohio, 44131, United States

  • Clinical Research Site #052 - Leading Edge Research LA, LLC

    Encino, California, 91316, United States

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Other studies related to the condition(s) this trial covers.