‘Off-label use of Risperidone in Children and Adolescents (ORCA): a double-blind placebo-controlled discontinuation trial’ - Discontinuation of risperidone in children and adolescents

MCG0 个研究点开始时间: 2015年10月12日最近更新: 2015年12月7日

试验速览

暂无简介。

•In order to be eligible to participate in this study, a subject must meet all of the following criteria:
•Be between the ages of six and seventeen years and eight months
•Current risperidone use = one year.
•Current risperidone doses = 5 mg/day.
•IQ > 70 (based on a previous IQ test or attending regular education).
•Parents (or the legal guardian) and children (= twelve years) have provided informed consent to participate in the study.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 120
•F.1.2 Adults (18-64 years) no
•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

•A potential subject who meets any of the following criteria will be excluded from participation in this study:
•Risperidone was discontinued for = two months in the last year.
•Current psychosis.
•Pregnancy.
•Risperidone is primarily used for the treatment of psychosis, or tics.
•Having parents who are planning to start other psychosocial and pharmacological therapies during the blinded period.
•Having parents who are unable to understand or comply with the protocol.
•Presence of any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the study, or may influence the results of the study, or the participant’s ability to participate in the study.

发起方

MCG