EUCTR2010-020696-23-SEActive, not recruitingNot Applicable
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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- F. Hoffmann-La Roche Ltd
- Enrollment
- 600
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •- Adult patients, >/= 18 years of age
- •- Diagnosis of schizophrenia
- •- Clinical stability for the 16 weeks (4 months) prior to
- •randomization
- •- Antipsychotic treatment stability for 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)
- •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
- •- 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) < 17 kg/m2 or > 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
Investigators
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