A Study of RO4917838 (Bitopertin) in Patients With Sub-optimally Controlled Symptoms of Schizophrenia (WN25305)

Study Overview
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Brief Summary
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This randomized, multi-center double-blind, parallel-group, placebo-controlled study will evaluate the efficacy and safety of RO4917838 (bitopertin) in patients with sub-optimally controlled symptoms of schizophrenia. Patients, on stable treatment with antipsychotics, will be randomized to receive daily oral doses of RO4917838 or matching placebo for 52 weeks, followed by an optional treatment extension for up to 3 years.

Official Title
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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.

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Placebo
* Drug: bitopertin [RO4917838] level 1
* Drug: bitopertin [RO4917838] level 2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients, >/= 18 years of age Diagnosis of schizophrenia Clinical stability for 16 weeks (4 months) prior to randomization Antipsychotic treatment stability for the past 12 weeks prior to randomization With the exception of clozapine, patients are on any of the available marketed atypical or typical antipsychotic (treatment with a maximum of two antipsychotics) 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 has a body mass index (BMI) of <17 or >40 kg/m2, respectively) Diagnosis of mental retardation or severe organic brain syndromes In the investigator's judgment, a significant risk of suicide or violent behavior

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Oral doses, once a day for 52 weeks<br>|
| Experimental: bitopertin [RO4917838] 1<br> | Drug: bitopertin [RO4917838] level 1<br>* Oral dose level 1, once a day for 52 weeks<br>|
| Experimental: bitopertin [RO4917838] 2<br> | Drug: bitopertin [RO4917838] level 2<br>* Oral dose level 2, once a day for 52 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive symptoms factor score assessed by Positive and Negative Syndrome Scale (PANSS) |  | Change from baseline to Week 12 | 
| Safety (incidence of adverse events) |  | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom domains of schizophrenia using Positive and Negative Syndrome Scale (PANSS) |  | Change from baseline to Week 12 | 
| Disease improvement on Clinical Global Impression - Improvement (CGI-I) symptoms scale |  | Change from baseline to Week 12 | 
| Disease severity on Clinical Global Impression - Severity (CGI-S) symptoms scale |  | Change from baseline to Week 12 | 
| Safety (incidence of adverse events) |  | 60 weeks |