Attention-Deficit/Hyperactivity DisorderPhase 3NCT05257265
A Trial of Centanafadine Efficacy and Safety in Adolescents With Attention- Deficit/Hyperactivity Disorder
A Phase 3 study testing Centanafadine Hydrochloride in people with Attention-Deficit/Hyperactivity Disorder, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 1 site in United States.
Trial summary
This trial was conducted to evaluate the efficacy and safety of the Centanafadine once daily (QD) extended release (XR) capsules in adolescent participants (13 - 17 years, inclusive) with attention-deficit/hyperactivity disorder (ADHD). Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Attention-Deficit/Hyperactivity Disorder
- What is being tested?
- Centanafadine Hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 459 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2022to 5 Oct 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Males and females aged 13 to 17 years (inclusive) at the time of informed consent/assent.
- A primary diagnosis of ADHD based on Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) diagnosis criteria as confirmed with the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID).
- A minimum symptoms total raw score of ≥ 28 on the Attention-Deficit/Hyperactivity Disorder Rating Scale Version 5 (ADHD-RS-5) at baseline for all participants.
- A score of 4 or higher on the Clinical Global Impression - Severity - Attention Deficit/Hyperactivity Disorder (CGI-S-ADHD) at baseline.
Who cannot join
- A comorbid diagnosis of: Tourette's Disorder, Generalized Anxiety Disorder severe enough to interfere with trial procedures, Panic Disorder, Conduct Disorder, Psychosis, Post-traumatic Stress Disorder, Bipolar Disorder, Autism Spectrum Disorder, Binge Eating Disorder, Anorexia, Bulimia, Oppositional Defiant Disorder severe enough to interfere with trial conduct (allowed if it is not the primary focus of treatment), Obsessive-Compulsive Disorder severe enough to interfere with trial conduct (allowed if it is not the primary focus of treatment), or major depressive disorder (MDD) with current major depressive episode.
- Participants who are breast-feeding and/or have a positive pregnancy test result prior to receiving investigational medicinal product (IMP).
- A significant risk of committing suicide based on history and the investigator's clinical judgment, or routine psychiatric status examination, Current suicidal behavior, Imminent risk of injury to self, Active suicidal ideation. History of suicidal behavior (over the last 6 months).
- Body mass index (BMI) ≥ 40 kg/m2 or ≤ 5th percentile for age and gender based on United States (US) Centers for Disease Control and Prevention (CDC) criteria.
- Has initiated, changed, or discontinued receiving psychological interventions for ADHD within the 30 days before the screening visit, or is anticipated to start new treatment during the trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
For additional information regarding sites, contact 844-687-8522
New York, New York, 10012
About this study
Official title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Determine the Efficacy and Safety of Once Daily Centanafadine Capsules for the Treatment of Adolescents With Attention-deficit/Hyperactivity Disorder
This trial was conducted to evaluate the efficacy and safety of the Centanafadine once daily (QD) extended release (XR) capsules in adolescent participants (13 - 17 years, inclusive) with attention-deficit/hyperactivity disorder (ADHD).
Read the detailed description
The trial consisted of a screening period of up to 28 days (4 weeks), a 42-day (6-week) double-blind treatment period, and a 7 (+ 2)-day follow-up period.
- Conditions
- Attention-Deficit/Hyperactivity Disorder
- Being tested
- Centanafadine Hydrochloride, Placebo
- Keywords
- Centanafadine, ADHD
- 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 HydrochlorideDrug
Also called Centanafadine QD XR
Capsule
PlaceboOther
Also called Matching Placebo
Capsule
| Study group | Role | What they receive |
|---|---|---|
| Centanafadine 164.4 mg | Experimental | Participants received centanafadine hydrochloride 164.4 milligrams (mg) XR capsules, orally, QD up to 6 weeks. Receives: Drug: Centanafadine Hydrochloride |
| Centanafadine 328.8 mg | Experimental | Participants received centanafadine hydrochloride 328.8 mg XR capsules, orally, QD up to 6 weeks. Receives: Drug: Centanafadine Hydrochloride |
| Placebo | Placebo comparator | Participants received centanafadine matching placebo capsules, orally, QD up to 6 weeks. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attention-Deficit/Hyperactivity Disorder Rating Scale Version 5 (ADHD-RS-5)
Change from baseline in the ADHD-RS-5 symptoms total raw score (investigator interview with informant) at Week 6.
Measured: From baseline to week 6
Secondary outcomes (2)
Clinical Global Impression - Severity - Attention-Deficit/Hyperactivity Disorder (CGI-S-ADHD)
Change from baseline in CGI-S-ADHD at Week 6
Measured: From baseline to week 6
Conners-3 Parent Short- Change from baseline in Conners-3 Parent Short at Week 6
Measured: From baseline to week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study start2 Feb 2022
- Primary completion29 Sep 2023
- Study completion5 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 459 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05257265
- Sponsor's protocol ID
- 405-201-00016
- Status last verified
- Sep 2024
- First submitted
- 16 Feb 2022
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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.
Publications
Ward CL, Oberdhan D, Jin N, Skubiak T, van Stralen J, Mattingly GW, Childress AC. Clinically Meaningful Within-Patient Change in Core Attention-Deficit/Hyperactivity Disorder Symptoms in Children and Adolescents Treated With Centanafadine: Results From Two Phase 3 Randomized Clinical Trials. J Atten Disord. 2026 Sep 23:10870547261483444. doi: 10.1177/10870547261483444. Online ahead of print.
PubMed 42779129Ward CL, Childress AC, Jin N, Turkoglu O, Skubiak T, Wilens TE. Centanafadine for Attention-Deficit/Hyperactivity Disorder in Adolescents: A Randomized Clinical Trial. J Am Acad Child Adolesc Psychiatry. 2026 Jun;65(6):805-817. doi: 10.1016/j.jaac.2025.06.023. Epub 2025 Jul 4.
PubMed 40619095
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Determine the Efficacy and Safety of Once Daily Centanafadine Capsules for the Treatment of Adolescents With Attention-deficit/Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT05257265
- Acronym / sponsor ID
- 405-201-00016
- Conditions
- Attention-Deficit/Hyperactivity Disorder
- Keywords
- Centanafadine, ADHD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 459 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Feb 2022 (actual)
- Primary completion
- 29 Sep 2023 (actual)
- Study completion
- 5 Oct 2023 (actual)
- First posted
- 25 Feb 2022 (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.
This trial was conducted to evaluate the efficacy and safety of the Centanafadine once daily (QD) extended release (XR) capsules in adolescent participants (13 - 17 years, inclusive) with attention-deficit/hyperactivity disorder (ADHD).
Detailed description
The trial consisted of a screening period of up to 28 days (4 weeks), a 42-day (6-week) double-blind treatment period, and a 7 (+ 2)-day follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Centanafadine 164.4 mg | Experimental | Drug: Centanafadine HydrochlorideParticipants received centanafadine hydrochloride 164.4 milligrams (mg) XR capsules, orally, QD up to 6 weeks. |
| Centanafadine 328.8 mg | Experimental | Drug: Centanafadine HydrochlorideParticipants received centanafadine hydrochloride 328.8 mg XR capsules, orally, QD up to 6 weeks. |
| Placebo | Placebo comparator | Other: PlaceboParticipants received centanafadine matching placebo capsules, orally, QD up to 6 weeks. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Males and females aged 13 to 17 years (inclusive) at the time of informed consent/assent.
- A primary diagnosis of ADHD based on Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) diagnosis criteria as confirmed with the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID).
- A minimum symptoms total raw score of ≥ 28 on the Attention-Deficit/Hyperactivity Disorder Rating Scale Version 5 (ADHD-RS-5) at baseline for all participants.
- A score of 4 or higher on the Clinical Global Impression - Severity - Attention Deficit/Hyperactivity Disorder (CGI-S-ADHD) at baseline.
Key exclusion criteria (5 listed)
- A comorbid diagnosis of: Tourette's Disorder, Generalized Anxiety Disorder severe enough to interfere with trial procedures, Panic Disorder, Conduct Disorder, Psychosis, Post-traumatic Stress Disorder, Bipolar Disorder, Autism Spectrum Disorder, Binge Eating Disorder, Anorexia, Bulimia, Oppositional Defiant Disorder severe enough to interfere with trial conduct (allowed if it is not the primary focus of treatment), Obsessive-Compulsive Disorder severe enough to interfere with trial conduct (allowed if it is not the primary focus of treatment), or major depressive disorder (MDD) with current major depressive episode.
- Participants who are breast-feeding and/or have a positive pregnancy test result prior to receiving investigational medicinal product (IMP).
- A significant risk of committing suicide based on history and the investigator's clinical judgment, or routine psychiatric status examination, Current suicidal behavior, Imminent risk of injury to self, Active suicidal ideation. History of suicidal behavior (over the last 6 months).
- Body mass index (BMI) ≥ 40 kg/m2 or ≤ 5th percentile for age and gender based on United States (US) Centers for Disease Control and Prevention (CDC) criteria.
- Has initiated, changed, or discontinued receiving psychological interventions for ADHD within the 30 days before the screening visit, or is anticipated to start new treatment during the trial.
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 HydrochlorideAlso: Centanafadine QD XRCapsule | Drug | Centanafadine 164.4 mg, Centanafadine 328.8 mg |
| PlaceboAlso: Matching PlaceboCapsule | Other | Placebo |
Primary outcome
Attention-Deficit/Hyperactivity Disorder Rating Scale Version 5 (ADHD-RS-5)
Time frame: From baseline to week 6
Change from baseline in the ADHD-RS-5 symptoms total raw score (investigator interview with informant) at Week 6.
2 secondary outcomes
Clinical Global Impression - Severity - Attention-Deficit/Hyperactivity Disorder (CGI-S-ADHD)
Time frame: From baseline to week 6
Conners-3 Parent Short- Change from baseline in Conners-3 Parent Short at Week 6
Time frame: From baseline to week 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- Derived from this study: PubMed 42779129Ward CL, Oberdhan D, Jin N, Skubiak T, van Stralen J, Mattingly GW, Childress AC. Clinically Meaningful Within-Patient Change in Core Attention-Deficit/Hyperactivity Disorder Symptoms in Children and Adolescents Treated With Centanafadine: Results From Two Phase 3 Randomized Clinical Trials. J Atten Disord. 2026 Sep 23:10870547261483444. doi: 10.1177/10870547261483444. Online ahead of print.
- Derived from this study: PubMed 40619095Ward CL, Childress AC, Jin N, Turkoglu O, Skubiak T, Wilens TE. Centanafadine for Attention-Deficit/Hyperactivity Disorder in Adolescents: A Randomized Clinical Trial. J Am Acad Child Adolesc Psychiatry. 2026 Jun;65(6):805-817. doi: 10.1016/j.jaac.2025.06.023. Epub 2025 Jul 4.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 Hydrochloride in people with Attention-Deficit/Hyperactivity Disorder, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 1 site 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 5 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: finished, as of the sponsor's last update on 27 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attention-Deficit/Hyperactivity Disorder Rating Scale Version 5 (ADHD-RS-5) (time frame: From baseline to week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05257265, which also lists 2 linked publications.
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 27 Sep 2024.