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van CCT (UK)

van CCT (UK)

Off-label use of risperidone in people with intellectual disability: A discontinuation study

- candidate number23147
- NTR NumberNTR5509
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-okt-2015
- Secondary IDsNL53217.042.15 
- Public TitleOff-label use of risperidone in people with intellectual disability: A discontinuation study
- Scientific TitleA placebo-controlled discontinuation trial of off-label used risperidone in people with intellectual disability
- hypothesisWe expect that it is possible to discontinue long-term (>1 year) used risperidone prescribed for challenging behaviors in people with intellectual disability without a clinical relevant change in behavior. Furthermore, as a result of discontinuation we expect that health outcomes will improve, such as weight, cholesterol levels, prolactin levels and neurological symptoms (extrapyramidal symptoms and autonomic symptoms). As a result we also expect quality of life to improve after discontinuation of risperidone.
- Healt Condition(s) or Problem(s) studiedIntellectual disabillities, Behavioral problems, Risperidon
- Inclusion criteria1. IQ<70 as assessed by an authorized behavioral therapist
2. Age > 6 years
3. No history of chronic psychosis
4. Risperidone use>1 year
5. Challenging behavior was the reason of prescription of risperidone
6. Informed consent obtained from legal representative
- Exclusion criteria1. A history of schizophrenia, a bipolar disorder, or affective psychosis according to DSM IV or ICD-10 criteria
2. A history of unsuccessful withdrawal of antipsychotics in the past 6 months
3. The use of other antipsychotics in addition to risperidone use
4. Risperidone is administered as long-acting injections
5. Clients who do not receive 24 hour/a day care (by either a service provider or parents/family)
6. Clients who are pregnant or have the intention to become pregnant
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-nov-2015
- planned closingdate30-jun-2017
- Target number of participants100
- Interventionsthe intervention group will gradually discontinue the use of risperidone to placebo. The control group will continue the use of risperidone on their normal dose
- Primary outcomeBehavior measured by the irritability subscale of the Aberrant Behavior Checklist (ABC)
- Secondary outcome- Other ABC subscales
- Clinical Global Impression Scale (CGI)
- Abnormal Involuntary Movement Scale (AIMS)
- Barnes Akathisia Rating Scale (BARS)
- Unified Parkinsons Disease Rating Scale (UPDRS)
- Scales for Outcomes in Parkinson's disease AUTonomic symptoms (SCOPA-AUT)
- Epworth Sleepiness Scale (ESS)
- Personal Outcome Scale (POS)
- RAND-36
- Physical measures: length, weight, waist circumference, heart rate and blood pressure
- blood counts
From a blood draw, we will obtain measures on:
- metabolism: Fasting glucose, insulin, tryglycerides, high-density lipoproteins (HDL), low-density lipoproteins (LDL), leptine, total cholestrol and HbA1C
- endocrine parameters: prolactin, testosterone - bone turnover: P1NP, CTx, osteocalcine, vitamin D and calcium
- thyroid function: TSH, T4 and parathyroid hormone (PTH)
- pharmacokinetics: risperidone and 9-hydroxyrisperidone concentrations
- albumine, creatine, potasium and sodium levels predictor variables:
- demographic data and socio-economic status
- treatment history and psychiatric diagnosis
- Tanner stages of pubertal development
- challenging behavior self-efficacy scale
- the emotional reactions to challenging behavior scale
- knowledge of psychotropic drugs
- beliefs, support of caregivers
- Timepointsweek 0: baseline measurements
week 2: start discontinuation
week 6, 10, 14: measurements during discontinuation
week 16: end of discontinuation
week 18 and 24: blinded follow-up measurements
week 24: end of blinded phase
week 42: naturalistic follow-up
- Trial web site
- statusplanned
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
Stichting Fonds Zorgondersteuning, ZON-MW, The Netherlands Organization for Health Research and Development
- Publications
- Brief summaryOften people with intellectual disability use antipsychotics, including risperidone, for the treatment of challenging behavior. This use of risperidone is off-label, often long-term and can cause many side-effects. For that reason we will test the effectiveness of risperidone after long-term use in challenging behavior. This study is a placebo-controlled discontinuation study of risperidone, in which the effect of discontinuation is tested on behavior, health and quality of life.
- Main changes (audit trail)
- RECORD28-okt-2015 - 7-jan-2016

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