Inattention symptom in patients with ADHD
Conditions
Interventions
investigational material(s)
Generic name etc : SDT-001
INN of investigational material : -
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : Play SDT-001 e
Sponsors
SHIONOGI & CO., LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Main 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 judged unlikely to respond to it sufficiently.
Exclusion criteria
Exclusion criteria: Main Exclusion Criteria -Patients with personality disorder or intellectual disability -Patients who used prohibited concomitant drugs/therapies, or patients who received additional psychosocial treatments (including environmental coordination) or changes in conditions of psychosocial treatments 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)]
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety efficacy Efficacy -Attention Deficit/Hyperactivity Disorder Rating Scale IV (ADHD-RS-IV) (physician assessment) -ADHD-RS-IV (teacher assessment) -The Test of Variables of Attention (T.O.V.A.) Attention Comparison Score (ACS) -Impairment rating scale (IRS) -Clinical Global Impression-Improvement (CGI-I) Safety -Adverse events and adverse device effects | — |
Countries
Japan
Outcome results
None listed