Long-term Extension Study of SM-13496 (lurasidone HCl) in Patients with Schizophrenia

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221817

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: - Patients who are considered by the investigator eligible for the present study with no significant safety concerns - Patients who are fully informed of and understand the objectives, procedures, and possible benefits and risks of the study and who provide written voluntarily consent to participate in the study

Exclusion criteria

Exclusion criteria: - Patients who are planning pregnancy for the expected duration of the study - Patients who are otherwise considered ineligible for the study by the investigator

Design outcomes

Primary

Measure	Time frame
PANSS total Score Change from baseline in PANSS total score	—

Secondary

Measure	Time frame
Adverse Event the proportion of subjects with Adverse Events (AEs), Discontinuations due to AEs, and Serious Adverse Events (SAEs).	—

Outcome results

None listed

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