Long-Term Extension Study of RO4917838 in Japanese Patients with Schizophrenia

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221884

Enrollment

165

Registered

2012-08-10

Start date

2012-08-10

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 : RO4917838 INN of investigational material : bitopertin Therapeutic category code : 117 Psychotropic agents Dosage and Administration for Investigational

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Patients who complete JN25535 study. -Patients who hope extended administration of RO4917838. -Patients who are considered appropriate for extended administration of RO4917838 by the investigator.

Exclusion criteria

Exclusion criteria: -Patients who are considered inappropriate for the study by the investigator.

Design outcomes

Primary

Measure	Time frame
-Incidence of adverse events. -Suicidality assessments -Incidence of adverse events -The items of the C-SSRS will be summarized and presented by individual listings.	—

Secondary

Measure	Time frame
-PANSS total, factor and subscale scores -Pharmacokinetics -Mean change from baseline of JN25535 study in the PANSS total, factor and subscale scores -plasma concentration of Ro4917838	—

Outcome results

None listed

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