Long term study of RG1678(RO4917838) in Japanese schizophrenic patients.

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221587

Enrollment

165

Registered

2011-09-20

Start date

2011-09-20

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 : RG1678(RO4917838) INN of investigational material : bitopertin Therapeutic category code : 117 Psychotropic agents Dosage and Administration for Investig

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Adult patients, aged 18 years and above -Diagnosis of schizophrenia of paranoid, disorganized, residual, undifferentiated or catatonic subtype -Predominant negative symptoms or Sub-optimally controlled symptoms -With the exception of clozapine, patients are on any of the available marketed atypical or typical antipsychotics (treatment with a maximum of two antipsychotics)

Exclusion criteria

Exclusion criteria: -Evidence that patient has clinically significant, uncontrolled and unstable disorder (e.g. cardiovascular, renal, hepatic disorder) -Body Mass Index (BMI) 40 -History of neuroleptic malignant syndrome.

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 Mean change from baseline in the PANSS total, factor and subscale scores	—

Outcome results

None listed

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