A Randomized, Multicenter, Double-Blind, Non-inferiority Study of Paliperidone Palmitate 3 Month and 1 Month Formulations for the Treatment of Subjects with Schizophrenia

Janssen-Cilag International N.V.0 个研究点目标入组 1,288 人开始时间: 2012年7月31日最近更新: 2015年7月10日

研究概览

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•- Patients with schizophrenia for more than 1 year and whose symptoms are worsening in the opinion of the investigator - A total score in the Positive and Negative Syndrome Scale (PANSS) between 70 and 120 - Signed informed consent - Women must not be pregnant, breastfeeding, and if capable of pregnancy must practice an effective method of birth control - Men must agree to use a double-barrier method of birth control - Be medically stable on the basis of clinical laboratory tests, physical examination, medical history, vital signs, and electrocardiogram (ECG)
•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 1275
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 13

•- A diagnosis other than schizophrenia, e.g., dissociative disorder, bipolar disorder, major depressive disorder, schizoaffective disorder, schizophreniform disorder, autistic disorder, primary substance-induced psychotic disorder, dementia-related psychosis -Relevant history or current presence of any significant or unstable medical condition(s) determined to be clinically significant by the Investigator (ie, obesity, diabetes, heart disease etc) - A diagnosis of substance dependence within 6 months before screening - History of neuroleptic malignant syndrome (NMS) or tardive dyskinesia - Clozapine use in the last 2 months when used for treatment-resistant or treatment-refractory illness – Clinically significant findings in biochemistry, hematology, ECG or urinalysis results - Any other disease or condition that, in the opinion of the investigator, would make participation not in the best interest of the patient or that could prevent, limit, or confound the protocol-specified assessments

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