Clinical trial for Attention-deficit/Hyperactivity Disorder
Official title A Study to Test the Effects of Centanafadine in Adults With Attention-deficit/Hyperactivity Disorder and Emotional Dysregulation
ClinicalTrials.gov ID: NCT07759154
What this study is testing
What is Centanafadine XR?
Centanafadine XR is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for attention-deficit/hyperactivity disorder.
Also referred to as EB-1020.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Primary diagnosis of ADHD per the Adult ADHD Clinical Diagnostic Scale (ACDS).
- Adult ADHD Investigator Symptom Rating Scale (AISRS) total score of ≥ 28 at baseline.
- Symptoms of ED as determined by the WRAADDS-ED subscale score ≥ 7 at baseline.
- CGI-S-ADHD rating ≥ 4 (at least moderate severity) at baseline.
You likely can't join if
- Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for a lifetime diagnosis of bipolar and related disorders...
- DSM-5 criteria for a current diagnosis of major depressive disorder, post-traumatic stress disorder, any substance use disorder, untreated/unstable...
- Any other current DSM-5 comorbid psychiatric disorder identified by the Mini International Neuropsychiatric Interview (MINI) or any medical condition...
- Presence of an unstable or uncontrolled medical condition that, in the opinion of the investigator, could pose a safety risk to the participant or...
- In the clinical opinion of the investigator, the participant has not derived significant therapeutic benefit from 2 or more ADHD therapies of 2...
- Current use of prohibited psychotropic medications that cannot be discontinued within 7 to 28 days prior to enrollment.
See the full eligibility criteria
- Primary diagnosis of ADHD per the Adult ADHD Clinical Diagnostic Scale (ACDS).
- Adult ADHD Investigator Symptom Rating Scale (AISRS) total score of ≥ 28 at baseline.
- Symptoms of ED as determined by the WRAADDS-ED subscale score ≥ 7 at baseline.
- CGI-S-ADHD rating ≥ 4 (at least moderate severity) at baseline.
- 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...
- 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...
- 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...
- 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).
- 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...
- Current use of prohibited psychotropic medications that cannot be discontinued within 7 to 28 days prior to enrollment.
- Any disorder that is the primary focus of treatment other than ADHD.
- Evidence of current substance use disorder or history in the past 12 months.
- History of any prior exposure to centanafadine.
- Participated in other clinical trials involving investigational drugs within 180 days prior to screening or participated in more than 2 treatment clinical trials involving investigational drugs within the past year.
- Have an allergy to the IMP or any component of the IMP. Note: Other protocol-specified inclusion/exclusion criteria may apply.
The study team makes the final eligibility decision.
Where it's taking place
- Gainesville, Florida, United States
- Jacksonville, Florida, United States
- Maitland, Florida, United States
- New Orleans, Louisiana, United States
- Boston, Massachusetts, United States
- Watertown, Massachusetts, United States
- Saint Charles, Missouri, United States
- Las Vegas, Nevada, United States
- Cherry Hill, New Jersey, United States
- New York, New York, United States
- Cincinnati, Ohio, United States
- Portland, Oregon, United States
- Austin, Texas, United States
- Bellaire, Texas, United States
- Houston, Texas, United States
- Everett, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gainesville, Florida, United States; Jacksonville, Florida, United States; Maitland, Florida, United States; New Orleans, Louisiana, United States; Boston, Massachusetts, United States; Watertown, Massachusetts, United States and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.