Safety and Pharmacokinetics of Antipsychotics in Children 2: Studying TDM in an RCT (SPACe2:STAR)

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.

Study Overview

• Status: Recruiting
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Other: Therapeutic Drug Monitoring; Other: Risperidone plasma level

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Birgit Koch; Email: b.koch@erasmusmc.nl

Study Locations

• Netherlands
  • Rotterdam, Netherlands
    • Recruiting
    • Erasmus Medical Center
    • Contact: Rebecca Hermans; Email: SPACe@erasmusmc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BMI z-score	Difference in body mass index z-scores 6 months after start of treatment.	6 months

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Erasmus Medical Center
• Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development; Stichting de Merel

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: November 9, 2021
• First Submitted That Met QC Criteria: November 23, 2021
• First Posted (Actual): December 6, 2021

Study Record Updates

• Last Update Posted (Estimated): December 8, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Risperidone; Therapeutic Drug Monitoring
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Dopamine Agents; Serotonin Antagonists; Dopamine Antagonists; Risperidone
• Other Study ID Numbers: MEC-2021-0278; 2020-005450-18 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No