Schizophrenia
Conditions
Brief summary
This randomized, multi-center, double-blind, parallel-group, placebo-controlled study will evaluate the efficacy and safety of RO4917838 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.
Interventions
DRUGRO4917838
Oral dose level 1, once a day for 52 weeks
DRUGPlacebo
Oral doses, once a day for 52 weeks
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
Argentina, Australia, Colombia, Finland, France, Hungary, India, Mexico, Romania, Russia, South Korea, Sweden, United Kingdom, United States
Outcome results
None listed