Off-label risperidone in children and adolescents (ORCA): Discontinuation study

• Conditions: no specific condition, we will investigate children who have been using risperidone on an off-label basis for at least one year.; Therapeutic area: Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04]

• Registration Number: EUCTR2014-003651-54-NL
• Lead Sponsor: MCG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-12
• Last Update Posted: 7 December 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified