Clinical Trials in the USA / NCT07759154
Recruiting
Phase 3
A Study to Test the Effects of Centanafadine in Adults With Attention-deficit/Hyperactivity Disorder and Emotional Dysregulation
NCT07759154 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Attention-deficit/Hyperactivity DisorderEmotional Dysregulation
Investigational drug(s) / intervention(s)
Centanafadine XR
Centanafadine XR: Oral capsules
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).
Eligibility
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
1. 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.
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 washout, 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 investigational 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.
Primary outcome measure(s)
- Change From Baseline to Week 8 in the Wender-Reimherr Adult Attention Deficit Disorder Scale (WRAADDS) Total Score — Baseline up to Week 8
Trial sites (16)
| Facility | City | Region | Status |
|---|---|---|---|
| Sarkis Clinical Trials - Gainesville | Gainesville | Florida | Not Yet Recruiting |
| CNS Healthcare - Jacksonville (Clinical Neuroscience Solutions - Jacksonville) | Jacksonville | Florida | Not Yet Recruiting |
| Accel Research Sites-Maitland | Maitland | Florida | Not Yet Recruiting |
| Nola Research Works | New Orleans | Louisiana | Recruiting |
| Boston Clinical Trials | Boston | Massachusetts | Not Yet Recruiting |
| Adams Clinical - Watertown | Watertown | Massachusetts | Not Yet Recruiting |
| St. Charles Psychiatric Associates/Midwest Research Group | Saint Charles | Missouri | Not Yet Recruiting |
| Center for Psychiatry and Behavioral Medicine. Inc. | Las Vegas | Nevada | Not Yet Recruiting |
| Center for Emotional Fitness | Cherry Hill | New Jersey | Recruiting |
| The Medical Research Network, LLC | New York | New York | Not Yet Recruiting |
| Patient Priority Clinical Trials | Cincinnati | Ohio | Not Yet Recruiting |
| Summit Research Network | Portland | Oregon | Recruiting |
| Donald J. Garcia, Jr, MD, PA | Austin | Texas | Recruiting |
| Houston Clinical Trials LLC | Bellaire | Texas | Recruiting |
| Kaleidoscope Clinical Research | Houston | Texas | Not Yet Recruiting |
| Core Clinical Research | Everett | Washington | Not Yet Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07759154 on ClinicalTrials.gov ↗ ← All trials in the USA