A Study of RO4917838 in Patients With Sub-optimally Controlled Symptoms of Schizophrenia.

Phase III, multi-center, randomized, 12-week, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of RO4917838 in patients with sub-optimally controlled symptoms of schizophrenia treated with antipsychotics followed by a 40-week double-blind, parallel group, placebo-controlled treatment period.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-020696-23-GB

Enrollment

600

Registered

2010-10-19

Start date

2011-03-28

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

Adjunctive treatment of patients with sub-optimally controlled symptoms of schizophrenia. Sub-optimally controlled patients are defined as those who on their current medication have persistent symptoms of psychosis. 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, >/= 18 years of age - Diagnosis of schizophrenia - Clinical stability for the 16 weeks (4 months) prior to randomisation - Antipsychotic treatment stability for 12 weeks prior to randomisation - With the exception of clozapine, patients are on any of the available marketed atypical or typical antipsychotic (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 540 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60

Exclusion criteria

Exclusion criteria: - Has treatment resistant schizophrenia as judged by the treating physician OR have failed two trials - Evidence that patient has clinically significant uncontrolled or unstable medical disorder (e.g. cardiovascular, renal hepatic, gastrointestinal, hematologic, immunological, neurological, endocrine, metabolic or pulmonary disease) - Patient with body mass index (BMI) 40 kg/m2 - Diagnosis of mental retardation or severe organic brain syndromes - In the investigator's judgment, a significant risk of suicide or violent behavior

Design outcomes

Primary

Measure	Time frame
Main Objective: • Evaluate the efficacy after 12 weeks of treatment with RO4917838 vs. placebo, as adjunct to antipsychotics, in the PANSS positive symptom factor score in patients with suboptimally controlled symptoms of schizophrenia; • Evaluate the safety and tolerability after 12 weeks of treatment with RO4917838 vs. placebo as adjunct to antipsychotics, in patients with sub-optimally controlled symptoms of schizophrenia. ; Secondary Objective: The secondary objectives of the study are to evaluate effects of 12 weeks of treatment with RO4917838 vs. placebo in patients with suboptimally controlled symptoms of schizophrenia treated with antipsychotics with respect to: • Symptoms domains of schizophrenia: PANSS total score, PANSS factor score of negative symptoms, disorganized thought, hostility/excitement, anxiety/depression; and PANSS syndrome subscale scores of positive, negative and general psychopathology symptoms at week 12; • The Clinical Global Impression - Improvement (CGI-I) positive and overall symptoms with "much" or "very much" improvement at week 12; • Clinical Global Impression - Severity (CGI-S) on overall and positive symptoms at week 12; • Personal and Social Performance (PSP) total score at 12 week; • Safety and tolerability of 52 weeks randomized study treatment. ; Primary end point(s): 1. Positive symptoms factor score assessed by Positive and Negative Syndrome Scale (PANSS) 2. Safety (incidence of adverse events) ; Timepoint(s) of evaluation of this end point: 1. Time Frame: Change from baseline to Week 12 2. Time Frame: Week 12	—

Measure

Time frame

Main Objective: • Evaluate the efficacy after 12 weeks of treatment with RO4917838 vs. placebo, as adjunct to antipsychotics, in the PANSS positive symptom factor score in patients with suboptimally controlled symptoms of schizophrenia; • Evaluate the safety and tolerability after 12 weeks of treatment with RO4917838 vs. placebo as adjunct to antipsychotics, in patients with sub-optimally controlled symptoms of schizophrenia. ; Secondary Objective: The secondary objectives of the study are to evaluate effects of 12 weeks of treatment with RO4917838 vs. placebo in patients with suboptimally controlled symptoms of schizophrenia treated with antipsychotics with respect to: • Symptoms domains of schizophrenia: PANSS total score, PANSS factor score of negative symptoms, disorganized thought, hostility/excitement, anxiety/depression; and PANSS syndrome subscale scores of positive, negative and general psychopathology symptoms at week 12; • The Clinical Global Impression - Improvement (CGI-I) positive and overall symptoms with "much" or "very much" improvement at week 12; • Clinical Global Impression - Severity (CGI-S) on overall and positive symptoms at week 12; • Personal and Social Performance (PSP) total score at 12 week; • Safety and tolerability of 52 weeks randomized study treatment. ; Primary end point(s): 1. Positive symptoms factor score assessed by Positive and Negative Syndrome Scale (PANSS) 2. Safety (incidence of adverse events) ; Timepoint(s) of evaluation of this end point: 1. Time Frame: Change from baseline to Week 12 2. Time Frame: Week 12

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Secondary

Measure	Time frame
Secondary end point(s): 1. Symptom domains of schizophrenia using Positive and Negative Syndrome Scale (PANSS) 2. Disease improvement on Clinical Global Impression - Improvement (CGI-I) symptoms scale 3. Disease severity on Clinical Global Impression - Severity (CGI-S) symptoms scale 4. Safety (incidence of adverse events) ; Timepoint(s) of evaluation of this end point: 1. Time Frame: Change from baseline to Week 12 2. Time Frame: Change from baseline to Week 12 3. Time Frame: Change from baseline to Week 12 4. Time Frame: Week 52	—

Measure

Time frame

Secondary end point(s): 1. Symptom domains of schizophrenia using Positive and Negative Syndrome Scale (PANSS) 2. Disease improvement on Clinical Global Impression - Improvement (CGI-I) symptoms scale 3. Disease severity on Clinical Global Impression - Severity (CGI-S) symptoms scale 4. Safety (incidence of adverse events) ; Timepoint(s) of evaluation of this end point: 1. Time Frame: Change from baseline to Week 12 2. Time Frame: Change from baseline to Week 12 3. Time Frame: Change from baseline to Week 12 4. Time Frame: Week 52

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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