long-term off-label risperidone treatment No specific condition
Conditions
Interventions
The participating subjects will be randomized (ratio 1:1) to either continued
use of risperidone or to placebo during sixteen weeks. Subjects will first be
switched to study medication in their regu
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
2 Years to 17 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure will be the D-total score of the Nisonger Child Behavior Rating Form-Typical IQ (NCBRF-TIQ). | — |
Secondary
| Measure | Time frame |
|---|---|
| - Strength and Difficulties Questionnaire (SDQ) - Retrospective Modified Overt Aggression Scale (R-MOAS) - Conners Teacher Rating Scale-Revised: short form (CTRS-R:S) - Clinical Global Impression Scale (CGI) - Children's Global Assessment Scale (CGAS) - Kindl-R (quality of life) - Parental Frustration Questionnaire (PFQ) - Amsterdam Neuropsychological Tasks (ANT) - UKU side effect rating scale (UKU-SERS) - Abnormal Involuntary Movement Scale (AIMS) - Barnes Akathisia Scale (BARS) - Unified Parkinson's disease rating scale (UPDRS) - Sleep Disturbances Scale for Children (SDSC) - appetite and life style - Physical Activity Questionnaire (PAQ) - Physical measures: length, weight, waist circumference, heart rate and blood pressure - Blood counts * Metabolism: fasting glucose, insulin, triglycerides, high-density lipoproteins (HDL), low-density lipoproteins (LDL), leptine, and total cholesterol. * Endocrine parameters: prolactin and testosterone. * Thyroid function: TSH and T4. * Kidney function: creatinine, sodium, and potassium. * Pharmacokinetics: risperidone and 9-hydroxyrisperidone concentrations. * Albumine levels. Predictor variables: - Demographic data and socio-economic status - Treatment history and psychiatric diagnosis - Tanner stages of pubertal development - Parent-rating scale for Reactive and Proactive Aggression (PRPA) - Nijmeegse OUderlijke Stress Index - kort (NOSI-K) - Alabama Parenting Questionnaire (APQ) | — |
Countries
Netherlands
Outcome results
None listed