Can we improve antipsychotic medication safety by measuring medication blood concentration in children and adolescents.

SPACe 2 STAR : Safety and pharmacokinetics of antipsychotics in children 2. Studying TDM in An RCT - SPACe 2 STAR

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-005450-18-NL

Enrollment

140

Registered

2021-06-08

Start date

2021-07-08

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

irritability in autism spectrum disorder

Interventions

Trade Name: Risperidone Pharmaceutical Form: Tablet INN or Proposed INN: RISPERIDONE CAS Number: 106266-06-2 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.5-1

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age 6 to 18 years AND Documented clinical diagnosis of autism spectrum disorder according to DSM IV or DSM V and comorbid behavioural problems AND To start treatment with risperidone Are the trial subjects under 18? yes Number of subjects for this age range: 140 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: • 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)

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate if application of therapeutic drug monitoring of risperidone in clinical practice is able to reduce the number/severity of metabolic side effects, while retaining clinical effectiveness, in children with an autism spectrum disorder by means of a randomized controlled trial. ;Secondary Objective: Not applicable;Primary end point(s): Metabolic abnormalities •Weight (change in BMI-Z score) ;Timepoint(s) of evaluation of this end point: 24 weeks	—

Measure

Time frame

Main Objective: To investigate if application of therapeutic drug monitoring of risperidone in clinical practice is able to reduce the number/severity of metabolic side effects, while retaining clinical effectiveness, in children with an autism spectrum disorder by means of a randomized controlled trial. ;Secondary Objective: Not applicable;Primary end point(s): Metabolic abnormalities •Weight (change in BMI-Z score) ;Timepoint(s) of evaluation of this end point: 24 weeks

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Secondary

Measure	Time frame
Secondary end point(s): 1. Effectivity • Aberrant Behavior Checklist (ABC) 2. Safety parameters • Metabolic abnormalities (blood pressure, blood cholesterol, blood lipoproteins, blood fasting glucose, hormones ghrelin, prolactin and leptin) • Extrapyramidal symptom severity (AIMS) 3. Quality of Life • Pediatric quality of life questionnaire (PedsQL) • Clinical severity score (CGI);Timepoint(s) of evaluation of this end point: 4, 10 and 24 weeks	—

Measure

Time frame

Secondary end point(s): 1. Effectivity • Aberrant Behavior Checklist (ABC) 2. Safety parameters • Metabolic abnormalities (blood pressure, blood cholesterol, blood lipoproteins, blood fasting glucose, hormones ghrelin, prolactin and leptin) • Extrapyramidal symptom severity (AIMS) 3. Quality of Life • Pediatric quality of life questionnaire (PedsQL) • Clinical severity score (CGI);Timepoint(s) of evaluation of this end point: 4, 10 and 24 weeks

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Countries

Germany, Netherlands

Contacts

Public ContactDepartment Child Psychiatry

Erasmus MC

b.dierckx@erasmusmc.nl0031107040209

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026