No registrations found.
ID
Source
Brief title
Health condition
challenging behavior
intellectual disability
off-label risperidone
off-label antipsychotics
Sponsors and support
Intervention
Outcome measures
Primary outcome
Behavior 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
Background summary
Often 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.
Study objective
We 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.
Study design
week 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
Intervention
the intervention group will gradually discontinue the use of risperidone to placebo. The control group will continue the use of risperidone on their normal dose
Lotte Ramerman
Middenweg 19
Assen 9404 LL
The Netherlands
(0592) 33 41 00
lotte.ramerman@ggzdrenthe.nl
Lotte Ramerman
Middenweg 19
Assen 9404 LL
The Netherlands
(0592) 33 41 00
lotte.ramerman@ggzdrenthe.nl
Inclusion criteria
1. 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 criteria
1. 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
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5252 |
| NTR-old | NTR5509 |
| CCMO | NL53217.042.15 |
| OMON | NL-OMON43644 |