Attention-Deficit Hyperactivity Disorder(ADHD)
Conditions
Interventions
Administer EB-1020 at low dose or high dose, or a placebo, orally once daily.
Sponsors
Sanada Nobuhito
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Participants with a primary diagnosis of ADHD based on DSM-5 diagnostic criteria, differentiated from other mental disorders using the MINI-KID, excluding other specified ADHD or unspecified ADHD. 2)Participants with a symptom total raw score of >= 28 (if not receiving any pharmacological treatment for ADHD) or >= 22 (if receiving pharmacological treatment for ADHD) on the ADHD Rating Scale Version 5 (ADHD-RS-5) at screening. 3)Participants with a symptom total raw score of >= 28 on the ADHD-RS-5 at baseline. 4)Participants with a score of 4 or higher on the Clinical Global Impression Severity - ADHD (CGI-S-ADHD) at baseline.
Exclusion criteria
Exclusion criteria: 1)Participants who have a positive pregnancy test result at baseline. 2)Participants determined to have the following diseases based on an interview using the MINI-KID. -Tourette' s disorder -Panic disorder -Conduct disorder -Psychotic disorder -Post-traumatic stress disorder -Bipolar disorder 3)Participants with a generalized anxiety disorder requiring pharmacotherapy, based on the DSM-5 diagnostic criteria. 4)Participants with an autism spectrum disorder based on the DSM-5 diagnostic criteria. 5)Participants with a personality disorder, oppositional defiant disorder, or obsessive-compulsive disorder that is the primary focus of treatment, based on the DSM-5 diagnostic criteria. 6) Participants with a diagnosis of major depressive disorder (MDD), based on the DSM-5 diagnostic criteria who currently have a major depressive episode, or who have required treatment for MDD within the past 3 months prior to screening. Also, participants who, in the judgment of the investigator or subinvestigator, may have a worsening of MDD during the trial or may require treatment during the trial period. 7)Participants who have a diagnosis of intellectual disability with an intelligence quotient (IQ) score less than 70. 8)Participants who have a significant risk of committing suicide in the opinion of the investigator or subinvestigator, or based on the following evidence. -Active suicidal ideation as evidenced by an answer of ""yes"" on Questions 4 or 5 (over the last 6 months) on the section of suicidal ideation or a history of suicidal behavior (over the last 6 months) on the Baseline/Screening version of the Columbia-Suicide Severity Rating Scale (C-SSRS) at screening. 9)Participants with a diagnosis of substance use disorder. 10)Participants who have laboratory test results at screening as follows: -Platelets 2 x ULN -ALT > 2 x ULN -eGFR = 2 x ULN (except for the cases that the medical monitor determined that participant's inclusion is possible based on the discussion about the participant's condition with the investigator or subinvestigator) -Abnormal values for both free T4 and TSH 11)Participants who cannot agree to discontinuation of prohibited concomitant medication, such as ADHD medication or antidepressants.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in ADHD-RS-5 symptom total raw score at Week 6. | — |
Countries
China, Japan
Contacts
Public ContactDrug Information Center
Otsuka Pharmaceutical Co., LTD.
Outcome results
None listed