Autism Spectrum DisorderPhase 4SPACe2:STARNCT05146245
Safety and Pharmacokinetics of Antipsychotics in Children 2: Studying TDM in an RCT
A Phase 4 study testing Therapeutic Drug Monitoring and Risperidone plasma level in people with Autism Spectrum Disorder, run by Erasmus Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Therapeutic Drug Monitoring and Risperidone plasma level
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Dec 2021to May 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Birgit Koch contact
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus Medical Center
Rotterdam
Rebecca Hermans, SPACe@erasmusmc.nl
About this study
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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Therapeutic Drug Monitoring, Risperidone plasma level
- Keywords
- Risperidone, Therapeutic Drug Monitoring
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic Drug MonitoringOther
Physician receives dosing advice based on risperidone plasma level.
Risperidone plasma levelOther
Plasma levels of risperidone and 9-OH risperidone are measured in a Dried Blood Spot.
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic Drug Monitoring | Experimental | Physicians receive dosing advice based on measured blood levels of risperidone and 9-OH-risperidone. Receives: Other: Therapeutic Drug Monitoring; Other: Risperidone plasma level |
| Care As Usual | Active comparator | Physician decides on possible dosing changes without receiving advice based on blood levels. Receives: Other: Risperidone plasma level |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI z-score
Difference in body mass index z-scores 6 months after start of treatment.
Measured: 6 months
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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.
Measured: 6 months
Metabolic side effects (glucose)
Difference in level of glucose 6 months after start of treatment.
Measured: 6 months
Metabolic side effects (cholesterol)
Difference in levels of cholesterol and lipoproteins (LDL, HDL) 6 months after start of treatment.
Measured: 6 months
Metabolic side effects (triglycerides)
Difference in level of triglycerides 6 months after start of treatment.
Measured: 6 months
Endocrine side effects (prolactin)
Difference in level of prolactin 6 months after start of treatment.
Measured: 6 months
Extrapyramidal symptoms (EPS)
Difference in extrapyramidal symptoms measured by Abnormal Involuntary Movement Scale 6 months after start of treatment.
Measured: 6 months
Endocrine side effects (ghrelin)
Difference in level of ghrelin 6 months after start of treatment.
Measured: 6 months
Endocrine side effects (leptin)
Difference in level of leptin 6 months after start of treatment.
Measured: 6 months
Side effects (blood pressure)
Difference in diastolic and systolic blood pressure 6 months after start of treatment.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2021
- Study start1 Dec 2021
- Primary completionMay 2024 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Stichting de Merel, ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Principal investigator, Birgit Koch, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05146245
- Sponsor's protocol ID
- MEC-2021-0278
- Other IDs
- 2020-005450-18
- Acronym
- SPACe2:STAR
- Status last verified
- Dec 2023
- First submitted
- 9 Nov 2021
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36539734
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Pharmacokinetics of Antipsychotics in Children 2: Studying TDM in an RCT
- ClinicalTrials.gov ID
- NCT05146245
- Acronym / sponsor ID
- SPACe2:STAR / MEC-2021-0278
- Conditions
- Autism Spectrum Disorder
- Keywords
- Risperidone, Therapeutic Drug Monitoring
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Stichting de Merel, ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 6 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapeutic Drug Monitoring | Experimental | Other: Therapeutic Drug Monitoring, Other: Risperidone plasma levelPhysicians receive dosing advice based on measured blood levels of risperidone and 9-OH-risperidone. |
| Care As Usual | Active comparator | Other: Risperidone plasma levelPhysician decides on possible dosing changes without receiving advice based on blood levels. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic Drug MonitoringPhysician receives dosing advice based on risperidone plasma level. | Other | Therapeutic Drug Monitoring |
| Risperidone plasma levelPlasma levels of risperidone and 9-OH risperidone are measured in a Dried Blood Spot. | Other | Care As Usual, Therapeutic Drug Monitoring |
Primary outcome
BMI z-score
Time frame: 6 months
Difference in body mass index z-scores 6 months after start of treatment.
11 secondary outcomes
Effectivity (ABC)
Time frame: 6 months
Effectivity (CGI)
Time frame: 6 months
Quality of Life (PedsQL)
Time frame: 6 months
Metabolic side effects (glucose)
Time frame: 6 months
Metabolic side effects (cholesterol)
Time frame: 6 months
Metabolic side effects (triglycerides)
Time frame: 6 months
Endocrine side effects (prolactin)
Time frame: 6 months
Extrapyramidal symptoms (EPS)
Time frame: 6 months
Endocrine side effects (ghrelin)
Time frame: 6 months
Endocrine side effects (leptin)
Time frame: 6 months
Side effects (blood pressure)
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
- Derived from this study: PubMed 36539734Hermans 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Birgit Koch contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Therapeutic Drug Monitoring and Risperidone plasma level in people with Autism Spectrum Disorder, run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Birgit Koch (b.koch@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMI z-score (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05146245, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2023.