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RecruitingNCT07759154Updated Nov 6, 2026

A Study to Test the Effects of Centanafadine in Adults With Attention-deficit/Hyperactivity Disorder and Emotional Dysregulation

A Phase 3 interventional study of Centanafadine XR in Attention-deficit/Hyperactivity Disorder and Emotional Dysregulation, sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.. Recruiting at 16 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-06.

Sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc. (part of Otsuka Holdings Co., Ltd.) · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2026; still recruiting 2 months later.
Updated Nov 6, 2026Site recruiting status changedGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
80
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Attention-deficit/Hyperactivity Disorder
  • Emotional Dysregulation

Keywords

  • ADHD
  • ED
03

In context

Attention Deficit Disorder with Hyperactivity

1,817 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 296 are open to participants now.

This study's planned enrollment of 80 is above the median of 71 across 1,437 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.

Browse Attention Deficit Disorder with Hyperactivity studies →

Lead sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc. is the lead sponsor of 295 studies on the registry; 18 are open to participants now.

Of its 106 completed or terminated interventional studies of FDA-regulated products, 71 (67%) have results posted.

Browse Otsuka Pharmaceutical Development & Commercialization, Inc. studies →All Otsuka Holdings Co., Ltd. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria

  1. , 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 , 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 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.

Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Centanafadine XR

    Participants will receive centanafadine XR capsule 328.8 milligrams (mg), orally, QD, for 8 weeks.

    Drug: Centanafadine XR

Interventions

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. Change From Baseline to Week 8 in the Difficulties in Emotion Regulation Scale (DERS) Total Score

    Time frame: Baseline up to Week 8

  7. Change From Baseline to Week 8 in the Nonacceptance of Emotional Responses (NONACCEPT) DERS Subscale Score

    Time frame: Baseline up to Week 8

  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

  9. Change From Baseline to Week 8 in the Impulse Control Difficulties (IMPULSE) DERS Subscale Score

    Time frame: Baseline up to Week 8

  10. Change From Baseline to Week 8 in the Lack of Emotional Awareness (AWARE) DERS Subscale Score

    Time frame: Baseline up to Week 8

  11. 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

  12. Change From Baseline to Week 8 in the Lack of Emotional Clarity (CLARITY) DERS Subscale Score

    Time frame: Baseline up to Week 8

  13. 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

  14. Number of Participants With Adverse Events

    Time frame: Up to Week 9

  15. 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

07

Study locations

16 of 16 sites recruiting
08

References and documents

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

Time frame: Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.

Access criteria: Otsuka will share data on the Vivli data sharing platform: https://vivli.org/ourmember/Otsuka/

Data sharing details ↗ · clinical-trials.otsuka.com

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2026 (actual). Primary completion is estimated for May 2027, 8 months after the start.

Of 66 industry-sponsored phase 3 interventional studies under Attention Deficit Disorder with Hyperactivity, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 19. This study's planned 8 months is below that.

Counting every sponsor, half of 80 studies reached it within 14 months; a quarter within 7 and three quarters within 32.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 6, 2026
First posted
Aug 12, 2026
StartActual
Sep 1, 2026
Primary completionEst.
May 27, 2027
CompletionEst.
May 27, 2027
Last update
Nov 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
11 sites changed recruiting status (11 now recruiting)
Show 11 sites
  • Sarkis Clinical Trials - Gainesville · Gainesville, United StatesNot yet recruiting→Recruiting
  • CNS Healthcare - Jacksonville (Clinical Neuroscience Solutions - Jacksonville) · Jacksonville, United StatesNot yet recruiting→Recruiting
  • Accel Research Sites-Maitland · Maitland, United StatesNot yet recruiting→Recruiting
  • Boston Clinical Trials · Boston, United StatesNot yet recruiting→Recruiting
  • Adams Clinical - Watertown · Watertown, United StatesNot yet recruiting→Recruiting
  • St. Charles Psychiatric Associates/Midwest Research Group · Saint Charles, United StatesNot yet recruiting→Recruiting
  • Center for Psychiatry and Behavioral Medicine. Inc. · Las Vegas, United StatesNot yet recruiting→Recruiting
  • The Medical Research Network, LLC · New York, United StatesNot yet recruiting→Recruiting
  • Patient Priority Clinical Trials · Cincinnati, United StatesNot yet recruiting→Recruiting
  • Kaleidoscope Clinical Research · Houston, United StatesNot yet recruiting→Recruiting
  • Core Clinical Research · Everett, United StatesNot yet recruiting→Recruiting
Nov 6, 2026
Show all 1 update
  1. Nov 6, 2026
    11 sites changed recruiting status (11 now recruiting)
    Show 11 sites
    • Sarkis Clinical Trials - Gainesville · Gainesville, United StatesNot yet recruiting→Recruiting
    • CNS Healthcare - Jacksonville (Clinical Neuroscience Solutions - Jacksonville) · Jacksonville, United StatesNot yet recruiting→Recruiting
    • Accel Research Sites-Maitland · Maitland, United StatesNot yet recruiting→Recruiting
    • Boston Clinical Trials · Boston, United StatesNot yet recruiting→Recruiting
    • Adams Clinical - Watertown · Watertown, United StatesNot yet recruiting→Recruiting
    • St. Charles Psychiatric Associates/Midwest Research Group · Saint Charles, United StatesNot yet recruiting→Recruiting
    • Center for Psychiatry and Behavioral Medicine. Inc. · Las Vegas, United StatesNot yet recruiting→Recruiting
    • The Medical Research Network, LLC · New York, United StatesNot yet recruiting→Recruiting
    • Patient Priority Clinical Trials · Cincinnati, United StatesNot yet recruiting→Recruiting
    • Kaleidoscope Clinical Research · Houston, United StatesNot yet recruiting→Recruiting
    • Core Clinical Research · Everett, United StatesNot yet recruiting→Recruiting
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07759154
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Responsible party
Sponsor
First posted
Aug 12, 2026
Start date
Sep 1, 2026
Primary completion
May 27, 2027 (estimated)
Completion
May 27, 2027 (estimated)
Last update
Nov 6, 2026

Study contacts

Otsuka Call Center
Contact
otsuka-professionalservices@otsuka-us.com
844-687-8522

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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