NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
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
Health condition(s) or Problem(s) studiedAttention Deficit/Hyperactivity Disorder
Date of first enrollment26/05/2022
Target sample size150
Countries of recruitment
Study typeInterventional
Intervention(s)Comparison part : SDT-001 (+ Normal treatment) or Normal treatment Re-treatment part : SDT-001 (+ Normal treatment)

Outcome(s)

Primary OutcomeChange in the ADHD-RS-IV inattentive subscale score (physician assessment) from baseline to the last assessment (Week 6) in the treatment period
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum>= 6age old
Age maximum<= 17age old
GenderBoth
Include criteriaPatients 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 criteriaPatients 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

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
E-mail shionogiclintrials-admin@shionogi.co.jp
Affiliation Shionogi &amp; 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
E-mail shionogiclintrials-admin@shionogi.co.jp
Affiliation Shionogi &amp; Co., Ltd.