Confirmatory study of DSP-5423 in pediatric patients with schizophrenia.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221682

Enrollment

150

Registered

2011-12-28

Start date

2012-03-23

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

Schizophrenia

Interventions

investigational material(s) Generic name etc : DSP-5423 (blonanserin) INN of investigational material : Blonanserin Therapeutic category code : 117 Psychotropic agents Dosage and Administration for In

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who have a diagnosis of schizophrenia as defined by DSM-IV-TR Patients aged 12-18 years etc.

Exclusion criteria

Exclusion criteria: Patients who fall under a contraindication listed in the LONASEN package insert Patients who have ever been treated with blonanserin Patients with Parkinson disease etc.

Design outcomes

Primary

Measure	Time frame
efficacy Change from Baseline in PANSS total score at Week 6	—

Secondary

Measure	Time frame
safety efficacy pharmacokinetics Change from Baseline in CGI-S score at last evaluation visit Plasma concentration of DSP-5423 Frequency of adverse events	—

Countries

Japan

Outcome results

None listed

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