Actively Recruiting
Evaluation of the Efficacy and Safety of EB-1020 in Adult ADHD Patients
Led by Otsuka Pharmaceutical Co., Ltd. · Updated on 2025-08-03
630
Participants Needed
1
Research Sites
135 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the efficacy and examine the safety of two doses of EB-1020 QD XR capsule administered once daily orally in adult ADHD patients.
CONDITIONS
Official Title
Evaluation of the Efficacy and Safety of EB-1020 in Adult ADHD Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed primarily with ADHD according to DSM-5 criteria based on the Japanese version of the Conners' Adult ADHD Diagnostic Interview for DSM-IVTM (CAADID)
- AISRS total score of 28 points or higher if not receiving ADHD medication
- AISRS total score of 22 points or higher if receiving ADHD medication
- Age between 18 and 55 years
You will not qualify if you...
- Pregnant or breastfeeding participants or those testing positive for pregnancy at screening
- Current comorbid psychiatric disorders that require prohibited medications or could affect study assessments, including psychotic disorder, bipolar disorder, generalized anxiety disorder, obsessive-compulsive disorder, panic disorder, major depressive episode, or posttraumatic stress disorder
- Diagnosed with a personality disorder according to DSM-5 criteria
- Diagnosed with autism spectrum disorder according to DSM-5 criteria
- Diagnosed with intellectual disability with an IQ below 70
- Significant risk of suicide or history of suicidal behavior within past 6 months
- Current or past substance-related disorders excluding tobacco-related disorders
- Diagnosed with eating or feeding disorders
- Positive alcohol or urine drug tests at screening
- History or presence of neurological disorders such as epilepsy, seizures (other than infantile febrile seizures), syncope, Tourette's disorder, significant head trauma with loss of consciousness, dementia, cerebrovascular disease, Parkinson's disease, intracranial lesions, or other severe neurological disorders
- History or presence of cardiovascular diseases
- Laboratory test abnormalities including low platelets, low hemoglobin, low neutrophils, elevated liver enzymes, elevated creatinine, elevated creatine phosphokinase, abnormal thyroid function tests
- Unable to discontinue prohibited medications such as ADHD medications or antidepressants
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Maynds Tower Mental Clinic
Tokyo, Japan
Actively Recruiting
Research Team
D
Drug Information Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here