A Randomized, Double Blind, Parallel-Group Comparative Study of Flexibly Dosed Paliperidone Palmitate(25, 50, 75, 100 mg eq) Administered Every 4 Weeks and Flexibly Dosed Risperdal Consta (25, 37.5, or 50 mg) Administered Every 2 Weeks in Subjects with Schizophrenia - Comparative

Janssen-Cilag International NV0 个研究点目标入组 700 人开始时间: 2005年10月31日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•Male or female, age at least 18 or the minimum age to provide informed consent in the jurisdiction in which the study is taking place, whichever is greater,
•Met diagnostic criteria for schizophrenia according to DSM-IV
•(disorganized type [295.10], catatonic type [295.20], paranoid type [295.30], residual type [295.60], or undifferentiated type [295.90]) for at least 1 year before screening.
•A total PANSS score between 60 and 120, inclusive, at screening and baseline.
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•A primary, active DSM-IV diagnosis other than schizophrenia,
•A decrease of 25% in the PANSS score between screening and baseline as calculated using the table provided by the sponsor,
•A DSM-IV diagnosis of active substance dependence within 3 months before screening (nicotine and caffeine are not exclusionary.),

发起方