A Study to Test the Effects of Centanafadine in Adults With Attention-deficit/Hyperactivity Disorder and Emotional Dysregulation
Part of paid clinical trials in Gainesville, Florida.
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Study ID
- NCT07759154
- Phase
- PHASE3
- Status
- Recruiting
Conditions
- Attention-deficit/Hyperactivity Disorder
- Emotional Dysregulation
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 65 Years
- Healthy Volunteers
- Not accepted
Interventions
- Centanafadine XR — DRUGOral capsules
Study Details
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).
Key Dates
- First listed
- Aug 12, 2026
- Start date
- Sep 1, 2026
- Status verified
- Sep 2026
- Primary completion
- May 27, 2027
- Completion
- May 27, 2027
Study Design
- Enrollment
- 80 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Centanafadine XRParticipants will receive centanafadine XR capsule 328.8 milligrams (mg), orally, QD, for 8 weeks.
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 ]
Central Contacts
- Otsuka Call Center844-687-8522
Locations (16)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Sarkis Clinical Trials - Gainesville | Gainesville | Florida | 32607 | Sarkis (PRINCIPAL_INVESTIGATOR) |
| CNS Healthcare - Jacksonville (Clinical Neuroscience Solutions - Jacksonville) | Jacksonville | Florida | 32256 | Jones (PRINCIPAL_INVESTIGATOR) |
| Accel Research Sites-Maitland | Maitland | Florida | 32751 | Marraffino (PRINCIPAL_INVESTIGATOR) |
| Nola Research Works | New Orleans | Louisiana | 70125 | Hebert (PRINCIPAL_INVESTIGATOR) |
| Boston Clinical Trials | Boston | Massachusetts | 02132 | Mezhebovsky (PRINCIPAL_INVESTIGATOR) |
| Adams Clinical - Watertown | Watertown | Massachusetts | 02472 | Rutrick (PRINCIPAL_INVESTIGATOR) |
| St. Charles Psychiatric Associates/Midwest Research Group | Saint Charles | Missouri | 63304 | Mattingly (PRINCIPAL_INVESTIGATOR) |
| Center for Psychiatry and Behavioral Medicine. Inc. | Las Vegas | Nevada | 89128 | Childress (PRINCIPAL_INVESTIGATOR) |
| Center for Emotional Fitness | Cherry Hill | New Jersey | 08002 | Corcoran (PRINCIPAL_INVESTIGATOR) |
| The Medical Research Network, LLC | New York | New York | 10128 | Careri (PRINCIPAL_INVESTIGATOR) |
| Patient Priority Clinical Trials | Cincinnati | Ohio | 45215 | Popovitz (PRINCIPAL_INVESTIGATOR) |
| Summit Research Network | Portland | Oregon | 97210 | Essink (PRINCIPAL_INVESTIGATOR) |
| Donald J. Garcia, Jr, MD, PA | Austin | Texas | 78737 | Garcia (PRINCIPAL_INVESTIGATOR) |
| Houston Clinical Trials LLC | Bellaire | Texas | 77401 | Katic (PRINCIPAL_INVESTIGATOR) |
| Kaleidoscope Clinical Research | Houston | Texas | 77089 | Higgins (PRINCIPAL_INVESTIGATOR) |
| Core Clinical Research | Everett | Washington | 98201 | Knutson (PRINCIPAL_INVESTIGATOR) |
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