Off-label use of Risperidone in Children and Adolescents (ORCA): a double-blind placebo-controlled discontinuation trial

Phase 4

Completed

• Conditions: long-term off-label risperidone treatment; No specific condition; 10037173

• Registration Number: NL-OMON44901
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 120

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.

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
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome measure will be the D-total score of the Nisonger Child<br /><br>Behavior Rating Form-Typical IQ (NCBRF-TIQ).</p><br>