Attention-deficit/Hyperactivity DisorderPhase 3NCT07759154
A Study to Test the Effects of Centanafadine in Adults With Attention-deficit/Hyperactivity Disorder and Emotional Dysregulation
A Phase 3 study testing Centanafadine XR in people with Attention-deficit/Hyperactivity Disorder and Emotional Dysregulation, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 16 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Attention-deficit/Hyperactivity Disorder, Emotional Dysregulation
- What is being tested?
- Centanafadine XR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 16 sitesUnited States
- Study dates
- 1 Sep 2026to 27 May 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 cannot join
- 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.
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- 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.
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
16 sites in 1 country
United States16 sites, 16 recruiting
- Recruiting
Donald J. Garcia, Jr, MD, PA
Austin, Texas, 78737
Otsuka Call Center, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
Garcia
- Recruiting
Houston Clinical Trials LLC
Bellaire, Texas, 77401
Otsuka Call Center, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
Katic
- Recruiting
Boston Clinical Trials
Boston, Massachusetts, 02132
Otsuka Call Center, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
Mezhebovsky
- Recruiting
Center for Emotional Fitness
Cherry Hill, New Jersey, 08002
Otsuka Call Center, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
Corcoran
- Recruiting
Patient Priority Clinical Trials
Cincinnati, Ohio, 45215
Otsuka Call Center, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
Popovitz
- Recruiting
Core Clinical Research
Everett, Washington, 98201
Otsuka Call Center, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
Knutson
- Recruiting
Sarkis Clinical Trials - Gainesville
Gainesville, Florida, 32607
Otsuka Call Center, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
Sarkis
- Recruiting
Kaleidoscope Clinical Research
Houston, Texas, 77089
Otsuka Call Center, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
Higgins
- Recruiting
CNS Healthcare - Jacksonville (Clinical Neuroscience Solutions - Jacksonville)
Jacksonville, Florida, 32256
Otsuka Call Center, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
Jones
- Recruiting
Center for Psychiatry and Behavioral Medicine. Inc.
Las Vegas, Nevada, 89128
Otsuka Call Center, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
Childress
- Recruiting
Accel Research Sites-Maitland
Maitland, Florida, 32751
Otsuka Call Center, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
Marraffino
- Recruiting
Nola Research Works
New Orleans, Louisiana, 70125
Otsuka Call Center, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
Hebert
- Recruiting
The Medical Research Network, LLC
New York, New York, 10128
Otsuka Call Center, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
Careri
- Recruiting
Summit Research Network
Portland, Oregon, 97210
Otsuka Call Center, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
Essink
- Recruiting
St. Charles Psychiatric Associates/Midwest Research Group
Saint Charles, Missouri, 63304
Otsuka Call Center, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
Mattingly
- Recruiting
Adams Clinical - Watertown
Watertown, Massachusetts, 02472
Otsuka Call Center, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
Rutrick
About this study
Official title: 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
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).
- Being tested
- Centanafadine XR
- Keywords
- ADHD, ED
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Centanafadine XRDrug
Also called EB-1020
Oral capsules
| Study group | Role | What they receive |
|---|---|---|
| Centanafadine XR | Experimental | Participants will receive centanafadine XR capsule 328.8 milligrams (mg), orally, QD, for 8 weeks. Receives: Drug: Centanafadine XR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to Week 8 in the Wender-Reimherr Adult Attention Deficit Disorder Scale (WRAADDS) Total Score
Measured: Baseline up to Week 8
Secondary outcomes (15)
Change From Baseline to Week 8 in the Wender-Reimherr Adult Attention Deficit Disorder Scale Emotional Dysregulation (WRAADDS-ED) Subscale Score
Measured: Baseline up to Week 8
Change From Baseline to Week 8 in the Clinical Global Impressions-Severity Scale for Attention-Deficit/Hyperactivity Disorder (CGI-S-ADHD) Score
Measured: Baseline up to Week 8
Change From Baseline to Week 8 in the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) T-score for the Global Executive Composite (GEC) Scale
Measured: Baseline up to Week 8
Change From Baseline to Week 8 in the BRIEF-A T-score for the Behavioral Regulation Index (BRI) Scale
Measured: Baseline up to Week 8
Change From Baseline to Week 8 in the BRIEF-A T-score for the Metacognition Index (MI) Scale
Measured: Baseline up to Week 8
Change From Baseline to Week 8 in the Difficulties in Emotion Regulation Scale (DERS) Total Score
Measured: Baseline up to Week 8
Change From Baseline to Week 8 in the Nonacceptance of Emotional Responses (NONACCEPT) DERS Subscale Score
Measured: Baseline up to Week 8
Change From Baseline to Week 8 in the Difficulties Engaging in Goal-Directed Behavior (GOALS) DERS Subscale Score
Measured: Baseline up to Week 8
Change From Baseline to Week 8 in the Impulse Control Difficulties (IMPULSE) DERS Subscale Score
Measured: Baseline up to Week 8
Change From Baseline to Week 8 in the Lack of Emotional Awareness (AWARE) DERS Subscale Score
Measured: Baseline up to Week 8
Change From Baseline to Week 8 in the Limited Access to Emotion Regulation Strategies (STRATEGIES) DERS Subscale Score
Measured: Baseline up to Week 8
Change From Baseline to Week 8 in the Lack of Emotional Clarity (CLARITY) DERS Subscale Score
Measured: Baseline up to Week 8
Change From Baseline to Week 8 in the Attention-Deficit/Hyperactivity Disorder Symptoms, Executive Function Deficits, and Emotional Dyscontrol as Assessed by the Adult ADHD Self-Report Scale (ASRS) Score
Measured: Baseline up to Week 8
Number of Participants With Adverse Events
Measured: Up to Week 9
Number of Participants With Suicidal Ideation or Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Measured: Up to Week 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start1 Sep 2026
- Primary completion27 May 2027 (estimated)
- Study completion27 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention-deficit/Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Development & Commercialization, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07759154
- Sponsor's protocol ID
- 405-201-00231
- Status last verified
- Nov 2026
- First submitted
- 6 Aug 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07759154
- Acronym / sponsor ID
- 405-201-00231
- Keywords
- ADHD, ED
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 27 May 2027 (estimated)
- Study completion
- 27 May 2027 (estimated)
- First posted
- 12 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Centanafadine XR | Experimental | Drug: Centanafadine XRParticipants will receive centanafadine XR capsule 328.8 milligrams (mg), orally, QD, for 8 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Centanafadine XRAlso: EB-1020Oral capsules | Drug | Centanafadine XR |
Primary outcome
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
15 secondary outcomes
Change From Baseline to Week 8 in the Wender-Reimherr Adult Attention Deficit Disorder Scale Emotional Dysregulation (WRAADDS-ED) Subscale Score
Time frame: Baseline up to Week 8
Change From Baseline to Week 8 in the Clinical Global Impressions-Severity Scale for Attention-Deficit/Hyperactivity Disorder (CGI-S-ADHD) Score
Time frame: Baseline up to Week 8
Change From Baseline to Week 8 in the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) T-score for the Global Executive Composite (GEC) Scale
Time frame: Baseline up to Week 8
Change From Baseline to Week 8 in the BRIEF-A T-score for the Behavioral Regulation Index (BRI) Scale
Time frame: Baseline up to Week 8
Change From Baseline to Week 8 in the BRIEF-A T-score for the Metacognition Index (MI) Scale
Time frame: Baseline up to Week 8
Change From Baseline to Week 8 in the Difficulties in Emotion Regulation Scale (DERS) Total Score
Time frame: Baseline up to Week 8
Change From Baseline to Week 8 in the Nonacceptance of Emotional Responses (NONACCEPT) DERS Subscale Score
Time frame: Baseline up to Week 8
Change From Baseline to Week 8 in the Difficulties Engaging in Goal-Directed Behavior (GOALS) DERS Subscale Score
Time frame: Baseline up to Week 8
Change From Baseline to Week 8 in the Impulse Control Difficulties (IMPULSE) DERS Subscale Score
Time frame: Baseline up to Week 8
Change From Baseline to Week 8 in the Lack of Emotional Awareness (AWARE) DERS Subscale Score
Time frame: Baseline up to Week 8
Change From Baseline to Week 8 in the Limited Access to Emotion Regulation Strategies (STRATEGIES) DERS Subscale Score
Time frame: Baseline up to Week 8
Change From Baseline to Week 8 in the Lack of Emotional Clarity (CLARITY) DERS Subscale Score
Time frame: Baseline up to Week 8
Change From Baseline to Week 8 in the Attention-Deficit/Hyperactivity Disorder Symptoms, Executive Function Deficits, and Emotional Dyscontrol as Assessed by the Adult ADHD Self-Report Scale (ASRS) Score
Time frame: Baseline up to Week 8
Number of Participants With Adverse Events
Time frame: Up to Week 9
Number of Participants With Suicidal Ideation or Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Up to Week 9
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Otsuka Clinical Trial WebsiteLink provided by the sponsor.
- Otsuka Clinical Trial TransparencyLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Anonymized individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Centanafadine XR in people with Attention-deficit/Hyperactivity Disorder and Emotional Dysregulation, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Otsuka Call Center (844-687-8522, otsuka-professionalservices@otsuka-us.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.