|- candidate number||23496|
|- NTR Number||NTR5595|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||16-dec-2015|
|- Secondary IDs||NL 52899.042.15 |
|- Public Title||Off-label use of Risperidone in Children and Adolescents (ORCA): a double-blind placebo-controlled discontinuation trial|
|- Scientific Title||Off-label use of Risperidone in Children and Adolescents (ORCA): a double-blind placebo-controlled discontinuation trial|
|- hypothesis||We will test the hypothesis that ongoing use of risperidone is superior to placebo with regard to behavioral symptoms in children and adolescents who have used risperidone for a year or longer.|
|- Healt Condition(s) or Problem(s) studied||Risperidon, Long term results|
|- 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||- Risperidone was discontinued for ≥ two months in the last year.|
- Current psychosis.
- 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.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||4-jan-2016|
|- planned closingdate||30-jun-2017|
|- Target number of participants||120|
|- Interventions||The participating subjects will be randomized (ratio 1:1) to either continued use of risperidone or to placebo during sixteen weeks. After two weeks of accommodating to the study medication, withdrawal will be gradual over a period of six weeks, followed by eight weeks of complete placebo. There will be four visits, at the start of the study, at baseline and after eight and fourteen weeks after baseline. After six months there will be a follow up by telephone.
|- Primary outcome||The primary outcome measure will be the D-total score of the Nisonger Child Behavior Rating Form-Typical IQ (NCBRF-TIQ).|
|- Secondary outcome||- 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, testosterone, and estradiol.
• Thyroid function: TSH, T4, and parathyreoid hormone.
• 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)
14 week follow-up and immediate breaking of the blind
Naturalistic follow-up after 6 months
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Msc M. Dinnissen|
|- CONTACT for SCIENTIFIC QUERIES||Msc M. Dinnissen|
|- Sponsor/Initiator ||University Medical Center Groningen (UMCG)|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||The ORCA study is a multicenter, double blind, placebo-controlled discontinuation trial in which 120 children and adolescents (6 to 17;8 years, IQ> 70) who have been using risperidone for over a year, will at random either gradually discontinue to placebo or continue their use. Discontinuation will be done in an 8-week period, after which participants will use only placebo for 8 weeks. Measurements will take place at baseline, 8 weeks and 14 weeks after baseline and after 6 months (naturalistic).
The aim is to determine whether long-term use of risperidone after at least a year is still effective, to determine the effects of discontinuing on behavior and physical health and the feasibility of stopping this treatment.|
|- Main changes (audit trail)|
|- RECORD||16-dec-2015 - 11-dec-2016|