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
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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
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
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.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.