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| Content Provider | Springer Nature : BioMed Central |
|---|---|
| Author | Hermans, Rebecca A. Ringeling, Lisa T. Liang, Kajie Kloosterboer, Sanne M. de Winter, Brenda C. M. Hillegers, Manon H. J. Koch, Birgit C. P. Dierckx, Bram |
| Abstract | Background Antipsychotic drugs are an important part of the treatment of irritability and aggression in children with an autism spectrum disorder (ASD). However, significant weight gain and metabolic disturbances are clinically relevant side effects of antipsychotic use in children. In the SPACe study, we showed positive correlations between both risperidone and aripiprazole plasma trough concentrations and weight gain over a 6-month period. The trial SPACe 2: STAR is designed as a follow-up study, in which we aim to research whether therapeutic drug monitoring in clinical practice can prevent severe weight gain, while retaining clinical effectiveness. Methods SPACe 2: STAR is an international, multicentre, randomised controlled trial (RCT). One hundred forty children aged 6 to 18 who are about to start risperidone or aripiprazole treatment for ASD related behavioural problems will be randomised into one of two groups: a therapeutic drug monitoring (TDM) group, and a care as usual (CAU) group. Participants will be assessed at baseline and 4, 10, 24, and 52 weeks follow-up. In the TDM group, physicians will receive dosing advice based on plasma levels of risperidone and aripiprazole and its metabolites at 4 and 10 weeks. Plasma levels will be measured in dried blood spots (DBS). The primary outcome will be BMI z-score at 24 weeks after start of antipsychotic treatment. Among the secondary outcomes are effectiveness, metabolic laboratory measurements, levels of prolactin, leptin and ghrelin, extrapyramidal side effects, and quality of life. Discussion This will be the first RCT evaluating the effect of TDM of antipsychotic drugs in children and adolescents. Thus, findings from SPACe 2: STAR will be of great value in optimising treatment in this vulnerable population. Trial registration ClinicalTrials.gov Identifier: NCT05146245. EudraCT number: 2020–005450-18. Sponsor protocol name: SPACe2STAR. Registered 8 June 2021. Protocol Version 6, Protocol date: 18 august 2022. |
| Related Links | https://bmcpsychiatry.biomedcentral.com/counter/pdf/10.1186/s12888-022-04445-6.pdf |
| Ending Page | 8 |
| Page Count | 8 |
| Starting Page | 1 |
| File Format | HTM / HTML |
| DOI | 10.1186/s12888-022-04445-6 |
| Journal | BMC Psychiatry |
| Issue Number | 1 |
| Volume Number | 22 |
| Language | English |
| Publisher | BioMed Central |
| Publisher Date | 2022-12-20 |
| Access Restriction | Open |
| Subject Keyword | Psychiatry Psychotherapy Randomised controlled trial Antipsychotic drugs Risperidone Aripiprazole Children Adolescents Autism spectrum disorder Therapeutic drug monitoring Pharmacokinetics Pharmacodynamics |
| Content Type | Text |
| Resource Type | Article |
| Subject | Psychiatry and Mental Health |
| Journal Impact Factor | 3.4/2023 |
| 5-Year Journal Impact Factor | 4.2/2023 |
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