SPACe2:STAR: Safety and Pharmacokinetics of Antipsychotics in Children 2: Studying TDM in an RCT
Study Details
Study Description
Brief Summary
The aim of this study is to test whether therapeutic drug monitoring of risperidone in children with autism spectrum disorder and comorbid behavioral problems is able to reduce metabolic side effect burden, while retaining clinical effectiveness.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Therapeutic Drug Monitoring Physicians receive dosing advice based on measured blood levels of risperidone and 9-OH-risperidone. |
Other: Therapeutic Drug Monitoring
Physician receives dosing advice based on risperidone plasma level.
Other: Risperidone plasma level
Plasma levels of risperidone and 9-OH risperidone are measured in a Dried Blood Spot.
|
| Active Comparator: Care As Usual Physician decides on possible dosing changes without receiving advice based on blood levels. |
Other: Risperidone plasma level
Plasma levels of risperidone and 9-OH risperidone are measured in a Dried Blood Spot.
|
Outcome Measures
Primary Outcome Measures
- BMI z-score [6 months]
Difference in body mass index z-scores 6 months after start of treatment.
Secondary Outcome Measures
- Effectivity (ABC) [6 months]
Difference on the Irritability scale of the Aberrant Behavior Checklist (scores ranging from 0 to 45, a higher score means more symptoms) 6 months after start of treatment.
- Effectivity (CGI) [6 months]
Difference on the Clinical Global Impression scale (scores ranging from 1 to 7, a higher score means higher severity) 6 months after start of treatment.
- Quality of Life (PedsQL) [6 months]
Difference on Pediatric Quality of Life Inventory (scores ranging from 0 to 100, a higher score indicates a better quality of life) 6 months after start of treatment.
- Metabolic side effects (glucose) [6 months]
Difference in level of glucose 6 months after start of treatment.
- Metabolic side effects (cholesterol) [6 months]
Difference in levels of cholesterol and lipoproteins (LDL, HDL) 6 months after start of treatment.
- Metabolic side effects (triglycerides) [6 months]
Difference in level of triglycerides 6 months after start of treatment.
- Endocrine side effects (prolactin) [6 months]
Difference in level of prolactin 6 months after start of treatment.
- Extrapyramidal symptoms (EPS) [6 months]
Difference in extrapyramidal symptoms measured by Abnormal Involuntary Movement Scale 6 months after start of treatment.
- Endocrine side effects (ghrelin) [6 months]
Difference in level of ghrelin 6 months after start of treatment.
- Endocrine side effects (leptin) [6 months]
Difference in level of leptin 6 months after start of treatment.
- Side effects (blood pressure) [6 months]
Difference in diastolic and systolic blood pressure 6 months after start of treatment.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age 6 to 18 years
-
Documented clinical diagnosis of autism spectrum disorder according to DSM IV or DSM V and comorbid behavioural problems
-
To start treatment with risperidone
Exclusion Criteria:
-
Diabetes type I or II
-
Congenital or acquired syndrome associated with changes in appetite, body weight or lipid profile (e.g. Prader Willi)
-
Treatment with antipsychotic medication within the last 6 months
-
Known Long QT syndrome (LQTS)
-
Pregnancy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Erasmus Medical Center | Rotterdam | Netherlands |
Sponsors and Collaborators
- Erasmus Medical Center
- Stichting de Merel
- ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MEC-2021-0278
- 2020-005450-18