behavioral problems Challenging behavior
Conditions
Interventions
The participants will be randomized in a 1:1 ratio to either ongoing use of
risperidone or gradual discontinuation to placebo in a period of 14 weeks.
Trial medication will be used by both groups un
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
2 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. IQ lower then 70 as assessed by an authorized behavioral therapist 2. Age over 6 years 3. No history of chronic psychosis 4. Risperidone use over1 year 5. Challenging behavior was the reason of prescription of risperidone 6. Informed consent obtained from legal representative
Exclusion criteria
Exclusion criteria: 1. A history of schizofrenia, 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 that do not receive 24 hour/a day care (by either a service provider or parents/family) 6. Clients that are pregnant or intention to become pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary end point is behaviopr meassured by the irritability subscale of the Aberrant Behaviour Checklist (ABC). The ABC was developed to assess (pharmaceutical) treatment effects on the challenging behaviors of people with intellectual disability (35-37). The ABC has 58 items divided over five subscales i.e., irritability (15 items), lethargy (16 items), stereotypic behavior (7 items), hyperactivity (16 items) and inappropriate speech (4 items). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameters are: - 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, triglycerides, high-density lipoproteins (HDL), low-density lipoproteins (LDL), leptine, total cholesterol, and HbA1C. - Endocrine parameters: prolactin, testosterone - Bone turnover: P1NP, CTx, osteocalcine, vitamin D, and calcium. - Thyroid function: TSH, T4, and parathyreoid hormone. - 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 predictor variables for caregivers: - Challenging Behavior Self-Efficacy Scale - the Emotional Reactions to Challenging Behavior Scale - knowledge of psychotropic drugs - beliefs of caregivers | — |
Countries
Netherlands
Outcome results
None listed