A comparative, randomized, open label, multicenter study on the efficacy and safety of switch treatment with aripiprazole in schizophrenic out-patient who are experiencing insufficient efficacy with risperidone and/or safety and tolerability issues, while on risperidone.

BRISTOL-M.SQUIBB0 个研究点目标入组 400 人开始时间: 2007年2月1日最近更新: 2012年4月24日

适应症

试验速览

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•Signed written informed consent
•1) Patients must be competent to understand the nature of the study, sign the informed
•consent, agree to comply with prescribed dosage regimens, report for regularly
•scheduled visits with their caring physician, able to provide reliable information for
•safety, efficacy and Quality of life assessments and communicate to the psychiatrist
•about adverse events and concomitant medication use (see Section 10.2.2);
•2) The informed consent process must be documented by signing the informed consent
•form prior to any study-related procedures including alteration in medications in
•preparation for study entry;
•Target population
•3) Patients with a diagnosis of schizophrenia as defined by DSM-IV-TR2 criteria
•(Appendix 2)
•4) Out-patients having symptoms which in the clinical judgment of the treating
•psychiatrist require treatment with antipsychotic (AP) medication.
•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) no
•F.1.3.1 Number of subjects for this age range

•Sex and Reproductive Status
•1) WOCBP who are unwilling or unable to use an acceptable method to avoid
•pregnancy for the entire study period and for up to 4 weeks after the study.
•2) WOCBP using a prohibited contraceptive method. No specific contraceptive
•methods are prohibited in this study. Women practicing abstinence should use a
•reliable method of contraception (except birth control pills, See Section 5.1) if they
•choose to become sexually active during the study.
•3) Women who are pregnant or breastfeeding

发起方

BRISTOL-M.SQUIBB