Interventional, open-label, flexible-dose extension study of aripiprazole once-monthly in patients with schizophrenia

H. Lundbeck A/S0 个研究点目标入组 100 人开始时间: 2013年8月5日最近更新: 2017年7月24日

适应症

试验速览

暂无简介。

•The patient is judged to potentially benefit from 24-week treatment with aripiprazole once-monthly according to the clinical opinion of the investigator.
•The patient agrees to protocol-defined use of effective contraception.
•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 100
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 0

•The patient has been diagnosed with a primary psychiatric disorder other than schizophrenia during Study 14724A / NCT01795547.
•The patient has a clinically significant unstable illness diagnosed during Study 14724A / NCT01795547.
•The patient is at significant risk of harming himself/herself or others according to the investigator's judgement or according to Columbia-Suicide Severity Rating Scale (C-SSRS).
•The patient has a disease or takes medication that could, in the investigator's opinion, interfere with the assessments of safety, tolerability or efficacy, or interfere with the conduct or interpretation of the study.
•The patient has one or more clinical laboratory test values outside the reference range, based on the blood or urine samples taken during the conduct of Study 14724A / NCT01795547 that are, in the investigator's opinion, of potential risk to the patient's safety.
•The patient is, in the investigator's opinion, unlikely to comply with the protocol or is unsuitable for any reason.

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