JRCT ID: jRCT2042220012
Registered date:28/04/2022
Phase 3 Study of SDT-001 in Pediatric Patients with Attention-deficit/Hyperactivity Disorder
Basic Information
Recruitment status | Not Recruiting |
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Health condition(s) or Problem(s) studied | Attention Deficit/Hyperactivity Disorder |
Date of first enrollment | 26/05/2022 |
Target sample size | 150 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | Comparison part : SDT-001 (+ Normal treatment) or Normal treatment Re-treatment part : SDT-001 (+ Normal treatment) |
Outcome(s)
Primary Outcome | Change in the ADHD-RS-IV inattentive subscale score (physician assessment) from baseline to the last assessment (Week 6) in the treatment period |
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Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | >= 6age old |
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Age maximum | <= 17age old |
Gender | Both |
Include 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. |
Exclude 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)] |
Related Information
Primary Sponsor | Nagata - Tsutae |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) |
Contact
Public contact | |
Name | Corporate Communications Department |
Address | 1-8, Doshomachi 3-chome, Chuo-ku, Osaka, Osaka Osaka Japan 541-0045 |
Telephone | +81-6-6209-7885 |
shionogiclintrials-admin@shionogi.co.jp | |
Affiliation | Shionogi & Co., Ltd. |
Scientific contact | |
Name | Tsutae - Nagata |
Address | 1-8, Doshomachi 3-chome, Chuo-ku, Osaka, Osaka Osaka Japan 541-0045 |
Telephone | +81-6-6209-7885 |
shionogiclintrials-admin@shionogi.co.jp | |
Affiliation | Shionogi & Co., Ltd. |