Phase II Study of S-877489 in Pediatric Patients with Attention-deficit/Hyperactivity Disorder
- Conditions
- Attention-deficit/Hyperactivity Disorder
- Registration Number
- JPRN-jRCT2080222081
- Lead Sponsor
- SHIONOGI & CO., LTD.
- Brief Summary
There is no new safety concerns in Japanese pediatric patients with ADHD who received S-877489 30-70mg for 4 weeks. The changes in ADHD-RS-IV total scoreat all evaluation points (Weeks 1-4) and the final evaluation point indicated a significant decrease from baseline(P<0.0001). The other endpoints (ADHD-RS-IV subscale score, Conners 3 symptom scale score and the total score, CGI-I, CGI-S, PGA, QCD) also showed improvement at the final evaluation point.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 33
1) Patient aged 6 years or older to less than 18 years at the time of signing the informed consent form.
2) Patient meets the DSM-IV-TR criteria for a primary diagnosis of ADHD (predominantly inattentive type [314.00], predominantly hyperactive-impulsive type [314.01], and combined type [314.01]). etc.
1) Patient has complications such as serious hepatic disorder, renal disorder, heart disease, lung disease, hematological disease, and metabolic disease.
2) Patient has psychiatric disorder such as schizophrenia, bipolar disorder, and pervasive development disorder.
3) Patient has personality disorder or mental retardation.
4) Patient has a documented allergy, hypersensitivity or intolerance to amphetamine.
5) Patient considered a suicide risk. etc.
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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