Safety and Pharmacokinetics of Antipsychotics in Children 2: Studying TDM in an RCT
SPACe2:STAR
2 other identifiers
interventional
140
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Dec 2021
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 9, 2021
CompletedStudy Start
First participant enrolled
December 1, 2021
CompletedFirst Posted
Study publicly available on registry
December 6, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2024
CompletedDecember 8, 2023
December 1, 2023
2.4 years
November 9, 2021
December 7, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
BMI z-score
Difference in body mass index z-scores 6 months after start of treatment.
6 months
Secondary Outcomes (11)
Effectivity (ABC)
6 months
Effectivity (CGI)
6 months
Quality of Life (PedsQL)
6 months
Metabolic side effects (glucose)
6 months
Metabolic side effects (cholesterol)
6 months
- +6 more secondary outcomes
Study Arms (2)
Therapeutic Drug Monitoring
EXPERIMENTALPhysicians receive dosing advice based on measured blood levels of risperidone and 9-OH-risperidone.
Care As Usual
ACTIVE COMPARATORPhysician decides on possible dosing changes without receiving advice based on blood levels.
Interventions
Physician receives dosing advice based on risperidone plasma level.
Plasma levels of risperidone and 9-OH risperidone are measured in a Dried Blood Spot.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Erasmus Medical Centerlead
- Stichting de Merelcollaborator
- ZonMw: The Netherlands Organisation for Health Research and Developmentcollaborator
Study Sites (1)
Erasmus Medical Center
Rotterdam, Netherlands
Related Publications (1)
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.
PMID: 36539734DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof.Dr.
Study Record Dates
First Submitted
November 9, 2021
First Posted
December 6, 2021
Study Start
December 1, 2021
Primary Completion
May 1, 2024
Study Completion
May 1, 2024
Last Updated
December 8, 2023
Record last verified: 2023-12