Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2020-005450-18 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Stichting de Merel | UNKNOWN |
| ZonMw: The Netherlands Organisation for Health Research and Development | OTHER |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Therapeutic Drug Monitoring | Experimental | Physicians receive dosing advice based on measured blood levels of risperidone and 9-OH-risperidone. |
|
| Care As Usual | Active Comparator | Physician decides on possible dosing changes without receiving advice based on blood levels. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Therapeutic Drug Monitoring | Other | Physician receives dosing advice based on risperidone plasma level. |
|
| Measure | Description | Time Frame |
|---|---|---|
| BMI z-score | Difference in body mass index z-scores 6 months after start of treatment. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Effectivity (ABC) | 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. | 6 months |
| Effectivity (CGI) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Birgit Koch | Contact | b.koch@erasmusmc.nl |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasmus Medical Center | Recruiting | Rotterdam | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36539734 | Derived | Hermans RA, Ringeling LT, Liang K, Kloosterboer SM, de Winter BCM, Hillegers MHJ, Koch BCP, Dierckx B. The effect of therapeutic drug monitoring of risperidone and aripiprazole on weight gain in children and adolescents: the SPACe 2: STAR (trial) protocol of an international multicentre randomised controlled trial. BMC Psychiatry. 2022 Dec 20;22(1):814. doi: 10.1186/s12888-022-04445-6. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Risperidone plasma level | Other | Plasma levels of risperidone and 9-OH risperidone are measured in a Dried Blood Spot. |
|
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.
| 6 months |
| Quality of Life (PedsQL) | 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. | 6 months |
| Metabolic side effects (glucose) | Difference in level of glucose 6 months after start of treatment. | 6 months |
| Metabolic side effects (cholesterol) | Difference in levels of cholesterol and lipoproteins (LDL, HDL) 6 months after start of treatment. | 6 months |
| Metabolic side effects (triglycerides) | Difference in level of triglycerides 6 months after start of treatment. | 6 months |
| Endocrine side effects (prolactin) | Difference in level of prolactin 6 months after start of treatment. | 6 months |
| Extrapyramidal symptoms (EPS) | Difference in extrapyramidal symptoms measured by Abnormal Involuntary Movement Scale 6 months after start of treatment. | 6 months |
| Endocrine side effects (ghrelin) | Difference in level of ghrelin 6 months after start of treatment. | 6 months |
| Endocrine side effects (leptin) | Difference in level of leptin 6 months after start of treatment. | 6 months |
| Side effects (blood pressure) | Difference in diastolic and systolic blood pressure 6 months after start of treatment. | 6 months |