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

Primary Purpose

Autism Spectrum Disorder

Status
Recruiting
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
Therapeutic Drug Monitoring
Risperidone plasma level
Sponsored by
Erasmus Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Autism Spectrum Disorder focused on measuring Risperidone, Therapeutic Drug Monitoring

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Erasmus Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Therapeutic Drug Monitoring

Care As Usual

Arm Description

Physicians receive dosing advice based on measured blood levels of risperidone and 9-OH-risperidone.

Physician decides on possible dosing changes without receiving advice based on blood levels.

Outcomes

Primary Outcome Measures

BMI z-score
Difference in body mass index z-scores 6 months after start of treatment.

Secondary Outcome Measures

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.
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.
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.
Metabolic side effects (glucose)
Difference in level of glucose 6 months after start of treatment.
Metabolic side effects (cholesterol)
Difference in levels of cholesterol and lipoproteins (LDL, HDL) 6 months after start of treatment.
Metabolic side effects (triglycerides)
Difference in level of triglycerides 6 months after start of treatment.
Endocrine side effects (prolactin)
Difference in level of prolactin 6 months after start of treatment.
Extrapyramidal symptoms (EPS)
Difference in extrapyramidal symptoms measured by Abnormal Involuntary Movement Scale 6 months after start of treatment.
Endocrine side effects (ghrelin)
Difference in level of ghrelin 6 months after start of treatment.
Endocrine side effects (leptin)
Difference in level of leptin 6 months after start of treatment.
Side effects (blood pressure)
Difference in diastolic and systolic blood pressure 6 months after start of treatment.

Full Information

First Posted
November 9, 2021
Last Updated
November 23, 2021
Sponsor
Erasmus Medical Center
Collaborators
Stichting de Merel, ZonMw: The Netherlands Organisation for Health Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT05146245
Brief Title
Safety and Pharmacokinetics of Antipsychotics in Children 2: Studying TDM in an RCT
Acronym
SPACe2:STAR
Official Title
Safety and Pharmacokinetics of Antipsychotics in Children 2: Studying TDM in an RCT
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Anticipated)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erasmus Medical Center
Collaborators
Stichting de Merel, ZonMw: The Netherlands Organisation for Health Research and Development

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
Risperidone, Therapeutic Drug Monitoring

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Therapeutic Drug Monitoring
Arm Type
Experimental
Arm Description
Physicians receive dosing advice based on measured blood levels of risperidone and 9-OH-risperidone.
Arm Title
Care As Usual
Arm Type
Active Comparator
Arm Description
Physician decides on possible dosing changes without receiving advice based on blood levels.
Intervention Type
Other
Intervention Name(s)
Therapeutic Drug Monitoring
Intervention Description
Physician receives dosing advice based on risperidone plasma level.
Intervention Type
Other
Intervention Name(s)
Risperidone plasma level
Intervention Description
Plasma levels of risperidone and 9-OH risperidone are measured in a Dried Blood Spot.
Primary Outcome Measure Information:
Title
BMI z-score
Description
Difference in body mass index z-scores 6 months after start of treatment.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Effectivity (ABC)
Description
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.
Time Frame
6 months
Title
Effectivity (CGI)
Description
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.
Time Frame
6 months
Title
Quality of Life (PedsQL)
Description
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.
Time Frame
6 months
Title
Metabolic side effects (glucose)
Description
Difference in level of glucose 6 months after start of treatment.
Time Frame
6 months
Title
Metabolic side effects (cholesterol)
Description
Difference in levels of cholesterol and lipoproteins (LDL, HDL) 6 months after start of treatment.
Time Frame
6 months
Title
Metabolic side effects (triglycerides)
Description
Difference in level of triglycerides 6 months after start of treatment.
Time Frame
6 months
Title
Endocrine side effects (prolactin)
Description
Difference in level of prolactin 6 months after start of treatment.
Time Frame
6 months
Title
Extrapyramidal symptoms (EPS)
Description
Difference in extrapyramidal symptoms measured by Abnormal Involuntary Movement Scale 6 months after start of treatment.
Time Frame
6 months
Title
Endocrine side effects (ghrelin)
Description
Difference in level of ghrelin 6 months after start of treatment.
Time Frame
6 months
Title
Endocrine side effects (leptin)
Description
Difference in level of leptin 6 months after start of treatment.
Time Frame
6 months
Title
Side effects (blood pressure)
Description
Difference in diastolic and systolic blood pressure 6 months after start of treatment.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Birgit Koch
Email
b.koch@erasmusmc.nl
Facility Information:
Facility Name
Erasmus Medical Center
City
Rotterdam
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecca Hermans
Email
SPACe@erasmusmc.nl

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Safety and Pharmacokinetics of Antipsychotics in Children 2: Studying TDM in an RCT

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