Phase 3 Study of SDT-001 in Pediatric Patients with Attention-deficit/Hyperactivity Disorder
Phase 3
- Conditions
- Attention Deficit/Hyperactivity Disorder
- Registration Number
- JPRN-jRCT2042220012
- Lead Sponsor
- agata - Tsutae
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
Patients diagnosed with ADHD according to the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) at the time of obtaining informed consent.
Patients who have received psychosocial treatment (including environmental coordination) for ADHD for a sufficient duration at the time of obtaining informed consent, and who are considered unlikely to respond to it sufficiently.
Exclusion Criteria
Patients with personality disorder or intellectual disability
Patients who used prohibited concomitant drugs/therapies, during the screening period.
Patients with suspected gaming disorder [conditions in which video games significantly interfere with daily life (e.g., school life or sleep)]
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method