A Phase III Study of SM-13496 (lurasidone HCl) in Patients with Schizophrenia

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

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221816

Enrollment

435

Registered

2012-06-06

Start date

2012-06-06

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 understands the objectives, procedures, and possible benefits and risks of the study and who provide written voluntarily consent to participate in the study 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
PANSS total Score Change from baseline in PANSS total score	—

Secondary

Measure	Time frame
CGI-S Change from baseline in CGI-S	—

Outcome results

None listed

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