A 12-week, Open-Label Extension Study of Lurasidone (SM-13496) in Subjects with Schizophrenia

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223209

Enrollment

283

Registered

2016-05-20

Start date

2016-10-18

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: - Subject has completed the study D1001066 and has completed all required assessments on the final study visit. - Subject 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 etc.

Exclusion criteria

Exclusion criteria: - Subject is considered by the Investigator to be at imminent risk of suicide or injury to self, or others. - Subject who are otherwise considered ineligible for the study by the investigator etc.

Design outcomes

Primary

Measure	Time frame
safety Adverse events (AEs) Frequency of AE or treatment-related AEs	—

Secondary

Measure	Time frame
efficacy PANSS total score Change frome baseline in PANSS total score	—

Countries

Japan

Outcome results

None listed

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