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Safety and pharmacokinetics of antipsychotics in children 2: Studying TDM in an RCT

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-511568-96-00
Acronym
NL75882.078.20
Enrollment
280
Registered
2024-07-16
Start date
Unknown
Completion date
Unknown
Last updated
2024-07-31

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

Conditions

Autism spectrum disorder

Brief summary

Difference between the groups in change in body mass index z-scores (BMI-Z) after 6 months of treatment

Detailed description

Difference between the groups in change in body mass index z-scores (BMI-Z) after 12 months of treatment., Aberrant Behavior Checklist, a parental symptom checklist for assessing problem behaviour in children. The gold standard for measuring the effect of treatment on aggression and irritability in children with autism spectrum disorder, EuroQol-5D Youth. A descriptive system for health-related quality of life states in five dimensions, plus a visual analogue scale., Pediatric Quality of Life Inventory. A modular instrument aimed at measuring healthrelated quality of life in children and adolescents. It showed excellent reliability and validity in individuals with autism spectrum disorder, Clinical Global Improvement, Treatment Inventory of Costs in Patients with psychiatric disorders. A modular questionnaire aimed at mapping healthcare utilization and the repercussions of psychosocial problems, allowing for the assessment of associated costs., Levels of glucose, cholesterol, lipoproteins and triglycerides; the hormones ghrelin, prolactin and leptin., Abnormal Involuntary Movement Scale, a clinician administered observational scale aimed at detecting extrapyramidal side effects., Blood pressure

Interventions

DRUGARIPIPRAZOLE
DRUGRISPERIDONE

Sponsors

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
0 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Difference between the groups in change in body mass index z-scores (BMI-Z) after 6 months of treatment

Secondary

MeasureTime frame
Difference between the groups in change in body mass index z-scores (BMI-Z) after 12 months of treatment., Aberrant Behavior Checklist, a parental symptom checklist for assessing problem behaviour in children. The gold standard for measuring the effect of treatment on aggression and irritability in children with autism spectrum disorder, EuroQol-5D Youth. A descriptive system for health-related quality of life states in five dimensions, plus a visual analogue scale., Pediatric Quality of Life Inventory. A modular instrument aimed at measuring healthrelated quality of life in children and adolescents. It showed excellent reliability and validity in individuals with autism spectrum disorder, Clinical Global Improvement, Treatment Inventory of Costs in Patients with psychiatric disorders. A modular questionnaire aimed at mapping healthcare utilization and the repercussions of psychosocial problems, allowing for the assessment of associated costs., Levels of glucose, cholesterol, lipoprote

Countries

Germany, Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026