Confirmatory Study of SM-13496 (lurasidone HCl) in Patients with Schizophrenia

Randomized, Placebo-controlled, Double-blind, Parallel-group, Confirmatory Study of SM-13496 (lurasidone HCl) in Patients with Schizophrenia

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080220563

Enrollment

460

Registered

2008-06-09

Start date

2008-06-09

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 : SM-13496 INN of investigational material : lurasidone Therapeutic category code : 117 Psychotropic agents Dosage and Administration for Investigational m

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patient meets DSM-IV criteria for schizophrenia. - Patient is 18 or older but younger than 75 years of age on the day of signing informed consent. - Patient understands the objectives, nature, and other aspects of the study and voluntarily agrees to participate in the study by providing written informed consent. etc.

Exclusion criteria

Exclusion criteria: - Patient has a history of neuroleptic malignant syndrome, water intoxication, or paralytic ileus. - Patient has Parkinson's disease. - Patient has a history or complication of malignancy. etc.

Design outcomes

Primary

Measure	Time frame
Change from baseline in PANSS total score	—

Outcome results

None listed

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