A Phase III, multi-center, randomized, 12 week, double-blind, parallel-group, placebo-controlled study to evaluate efficacy and safety of RG1678 (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.

Chugai Pharmaceutical Co., Ltd.0 个研究点目标入组 600 人开始时间: 2011年5月9日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•Adult patients, >/= 18 years of age
•-Diagnosis of schizophrenia
•-Clinical stability for 12 weeks prior to screening period
•-Antipsychotic treatment stability for 8 weeks prior to screening period
•-With the exception of clozapine, patients are on any of the available marketed atypical or typical antipsychotic (treatment with a maximum of two antipsychotics)

•-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 anorexia or obesity (body mass index (BMI) <18.5 or >40, respectively)
•-Diagnosis of mental retardation or severe organic brain syndromes
•-In the investigator's judgment, a significant risk of suicide or violent behavior

发起方