Safety and Pharmacokinetics of Antipsychotics in Children 2: Studying TDM in an RCT
NCT ID: NCT05146245
Last Updated: 2023-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE4
140 participants
INTERVENTIONAL
2021-12-01
2024-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Therapeutic Drug Monitoring
Physicians receive dosing advice based on measured blood levels of risperidone and 9-OH-risperidone.
Therapeutic Drug Monitoring
Physician receives dosing advice based on risperidone plasma level.
Risperidone plasma level
Plasma levels of risperidone and 9-OH risperidone are measured in a Dried Blood Spot.
Care As Usual
Physician decides on possible dosing changes without receiving advice based on blood levels.
Risperidone plasma level
Plasma levels of risperidone and 9-OH risperidone are measured in a Dried Blood Spot.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Therapeutic Drug Monitoring
Physician receives dosing advice based on risperidone plasma level.
Risperidone plasma level
Plasma levels of risperidone and 9-OH risperidone are measured in a Dried Blood Spot.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
6 Years
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Stichting de Merel
UNKNOWN
ZonMw: The Netherlands Organisation for Health Research and Development
OTHER
Erasmus Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Birgit Koch
Prof.Dr.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Erasmus Medical Center
Rotterdam, , Netherlands
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Rebecca Hermans
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2020-005450-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MEC-2021-0278
Identifier Type: -
Identifier Source: org_study_id