A Phase III study of SM-13496 in patients with schizophrenia

A 6-week, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lurasidone (SM-13496) in Acutely Psychotic Subjects with Schizophrenia

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223187

Enrollment

472

Registered

2016-04-27

Start date

2016-05-20

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: -Patients meets DSM-IV TR criteria for schizophrenia. -Patients 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: -Patients 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
efficacy PANSS total Score Change from baseline in PANSS total score	—

Secondary

Measure	Time frame
efficacy CGI-S Change frome baseline in CGI-S	—

Countries

Japan

Outcome results

None listed

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