Phase II Study of SDT-001 in Pediatric Patients with Attention-deficit/Hyperactivity Disorder
- Conditions
- Inattention symptom in patients with ADHD
- Registration Number
- JPRN-jRCT1080225158
- Lead Sponsor
- SHIONOGI & CO., LTD.
- Brief Summary
The ADHD-RS-IV score (physician's assessment) in the 6-week treatment period and all the endpoints indicated improving trends in the 6-week treatment period in both the SDT-001 group and the Sham group, but no statistically significant difference between the two groups. The above results suggest that SDT-001 may improve ADHD symptoms. There was no specific finding in terms of adverse device effects, and no significant safety concern was suggested during and after use of this device.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 262
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.
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)]
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
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