Off-label use of Risperidone in Children and Adolescents (ORCA): a double-blind placebo-controlled discontinuation trial
Recruiting
- Conditions
- Risperidone, long-term efficacy and safety, risperidon, langetermijn effectiviteit
- Registration Number
- NL-OMON20175
- Lead Sponsor
- niversity Medical Center Groningen (UMCG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- 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
Exclusion Criteria
- Risperidone was discontinued for ≥ two months in the last year.
- Current psychosis.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome measure will be the D-total score of the Nisonger Child Behavior Rating Form-Typical IQ (NCBRF-TIQ).
- Secondary Outcome Measures
Name Time Method