A Study of RO4917838 in Patients With Persistent, Predominant Negative Symptoms of Schizophrenia.

A Phase III, multi-center, randomized, 24 week, double-blind, parallel-group, placebo-controlled study to evaluate efficacy and safety of RO4917838 in stable patients with persistent, predominant negative symptoms of schizophrenia treated with antipsychotics followed by a 28 week double-blind treatment period.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-020370-42-GB

Enrollment

630

Registered

2010-10-08

Start date

2011-01-06

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment of negative symptoms for patients with schizophrenia treated with antipsychotics. MedDRA version: 14.1 Level: PT Classification code 10039626 Term: Schizophrenia System Organ Class: 10037175 - Psychiatric disorders

Interventions

Product Name: GlyT1 (1) Product Code: RO4917838/F18 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: not yet available CAS N

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 • With the exception of clozapine, patients are on any of the available marketed atypical or typical antipsychotics (treatment with a maximum of two antipsychotics) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Evidence that patient has clinically significant, uncontrolled and unstable disorder (e.g. cardiovascular, renal, hepatic disorder) • Patient with Body Mass Index (BMI) 40 kg/m2 • Depressive symptoms, defined as a score of 9 or greater on the Calgary Depression Rating Scale for Schizophrenia (CDSS) • A severity score of 3 or greater on the Parkinsonism item of the ESRS-A (Clinical Global Impression, Parkinsonism).

Design outcomes

Primary

Measure	Time frame
Main Objective: • Evaluate efficacy of 24 weeks treatment with RO4917838 in the PANSS negative symptom factor score in patients with persistent, predominant negative symptoms of schizophrenia treated with antipsychotics. • Evaluate safety and tolerability of 24 weeks treatment with RO4917838 in patients with persistent, predominant negative symptoms of schizophrenia treated with antipsychotics. ; Secondary Objective: Evaluate efficacy after 24 weeks of treatment with RO4917838 in patients with persistent, predominant negative symptoms of schizophrenia treated with antipsychotics: • PANSS NSFS in the CFHR1-high subgroup • personal and social functioning using PSP total score in the all-patient population and in the CFHR1-high subgroup Additional objectives: evaluate the effect of treatment with RO4917838 in patients with persistent, predominant negative symptoms of schizophrenia, in the all-patient population and the CFHR1 subgroups according to patient's CFHR1 serum at baseline with respect to: • Other symptom domains of schizophrenia: PANSS total score; PANSS factors: positive symptom, disorganized thought, hostility/excitement, anxiety/depression; PANSS subscales: positive, negative and general psychopathology at week 24; • Clinical Global Impression of severity and improvement on overall and negative symptoms at week 24; • Safety/tolerability of 52 weeks of randomized study treatment. ; Primary end point(s): 1. Efficacy (PANSS negative symptoms factor score) 2. Safety (incidence of adverse events) ;Timepoint(s) of evaluation of this end point: At week 24.	—

Measure

Time frame

Main Objective: • Evaluate efficacy of 24 weeks treatment with RO4917838 in the PANSS negative symptom factor score in patients with persistent, predominant negative symptoms of schizophrenia treated with antipsychotics. • Evaluate safety and tolerability of 24 weeks treatment with RO4917838 in patients with persistent, predominant negative symptoms of schizophrenia treated with antipsychotics. ; Secondary Objective: Evaluate efficacy after 24 weeks of treatment with RO4917838 in patients with persistent, predominant negative symptoms of schizophrenia treated with antipsychotics: • PANSS NSFS in the CFHR1-high subgroup • personal and social functioning using PSP total score in the all-patient population and in the CFHR1-high subgroup Additional objectives: evaluate the effect of treatment with RO4917838 in patients with persistent, predominant negative symptoms of schizophrenia, in the all-patient population and the CFHR1 subgroups according to patient's CFHR1 serum at baseline with respect to: • Other symptom domains of schizophrenia: PANSS total score; PANSS factors: positive symptom, disorganized thought, hostility/excitement, anxiety/depression; PANSS subscales: positive, negative and general psychopathology at week 24; • Clinical Global Impression of severity and improvement on overall and negative symptoms at week 24; • Safety/tolerability of 52 weeks of randomized study treatment. ; Primary end point(s): 1. Efficacy (PANSS negative symptoms factor score) 2. Safety (incidence of adverse events) ;Timepoint(s) of evaluation of this end point: At week 24.

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Secondary

Measure	Time frame
Secondary end point(s): The key secondary efficacy endpoint is the mean change from baseline in the Personal and Social Performance (PSP) total score.;Timepoint(s) of evaluation of this end point: At week 24.	—

Countries

Argentina, Finland, France, Hungary, India, Korea, Republic of, Mexico, Romania, Russian Federation, Sweden, United Kingdom, United States

Contacts

Public ContactTrial Information Support Line-TISL

F. Hoffmann-La Roche Ltd

global.rochegenentechtrials@roche.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026