Phase 3 Study of SDT-001 in Pediatric Patients with Attention-deficit/Hyperactivity Disorder

Phase 3 study of SDT-001 in Pediatric Patients with Attention-deficit/Hyperactivity Disorder consisting of randomized, open-label, nomal treatment-control, conparison part and extension, open-label, re-treatment part

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2042220012

Enrollment

150

Registered

2022-04-28

Start date

2022-05-26

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention Deficit/Hyperactivity Disorder

Interventions

Comparison part : SDT-001 (+ Normal treatment) or Normal treatment Re-treatment part : SDT-001 (+ Normal treatment)

Eligibility

Sex/Gender

All

Inclusion criteria

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 considered unlikely to respond to it sufficiently.

Exclusion criteria

Exclusion 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)]

Design outcomes

Primary

Measure	Time frame
Change in the ADHD-RS-IV inattentive subscale score (physician assessment) from baseline to the last assessment (Week 6) in the treatment period	—

Contacts

Public ContactCorporate Communications Department

Shionogi & Co., Ltd.

shionogiclintrials-admin@shionogi.co.jp+81-6-6209-7885

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026