Clinical trial • Phase IV • Psychiatry
ARIPIPRAZOLE for Autism spectrum disorder
Phase IV trial of ARIPIPRAZOLE for Autism spectrum disorder.
Overview
- Trial Therapeutic Area
- Psychiatry
- Trial Disease
- Autism spectrum disorder
- Trial Stage
- Phase IV
- Drug Modality
- Small molecule
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 20-06-2024
- First CTIS Authorization Date
- 16-07-2024
Trial design
Randomised, open-label, two-arm randomized comparison: therapeutic drug monitoring (tdm) arm — trough plasma levels measured (dbs) at weeks 4 and 10 with pk/pd model-based dosing advice provided to the treating psychiatrist (insightrx®); care as usual (cau) arm — no dosing recommendations. drugs used in participants are risperidone or aripiprazole per standard clinical care (dosing per local practice).-controlled Phase IV trial across 13 sites in Netherlands, Germany.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Two-arm randomized comparison: Therapeutic drug monitoring (TDM) arm — trough plasma levels measured (DBS) at weeks 4 and 10 with PK/PD model-based dosing advice provided to the treating psychiatrist (InsightRX®); Care As Usual (CAU) arm — no dosing recommendations. Drugs used in participants are risperidone or aripiprazole per standard clinical care (dosing per local practice).
- Real World Control
- Yes
- Target Sample Size
- 280
- Trial Duration For Participant
- 365
Eligibility
Recruits 280 paediatric patients.
- Pregnancy Exclusion
- Pregnancy
- Vulnerable Population
- Vulnerable population selected: children and adolescents (age 6–18). Subject information sheets and informed consent forms are provided for age groups 6-11 years, 12-15 years and 16-18 years, and a parent information/consent form is provided; minors require parental consent and age-appropriate participant information/assent as indicated by the age-specific ICF documents.
Inclusion criteria
- {"criterion_text":"- Age 6 to 18 years"}
- {"criterion_text":"- Documented clinical diagnosis of autism spectrum disorder according to DSM IV or DSM V and comorbid behavioural problems"}
- {"criterion_text":"- To start treatment with risperidone or aripiprazole"}
Exclusion criteria
- {"criterion_text":"- Diabetes type I or II"}
- {"criterion_text":"- Congenital or acquired syndrome associated with changes in appetite, body weight or lipid profile (e.g. Prader Willi)"}
- {"criterion_text":"- Known history of Long QT syndrome (LQTS), cardiovascular disorders (myocardial infarction or ischaemic heart disease, heart failure, or conduction abnormalities), seizure disorder or oesophageal dysmotility"}
- {"criterion_text":"- Pregnancy"}
- {"criterion_text":"- Hypersensitivity to the active substance or to any of the excipients"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Difference between the groups in change in body mass index z-scores (BMI-Z) after 6 months of treatment","definition_or_measurement_approach":"Change in BMI z-scores (BMI-Z) measured after 6 months of treatment comparing the two randomized groups."}
Secondary endpoints
- {"endpoint_text":"- Difference between the groups in change in body mass index z-scores (BMI-Z) after 12 months of treatment.","definition_or_measurement_approach":"Change in BMI z-scores (BMI-Z) measured after 12 months of treatment comparing the two groups."}
- {"endpoint_text":"- Aberrant Behavior Checklist, a parental symptom checklist for assessing problem behaviour in children. The gold standard for measuring the effect of treatment on aggression and irritability in children with autism spectrum disorder","definition_or_measurement_approach":"Aberrant Behavior Checklist (parent-rated) to assess severity of irritability and aggression; used to compare drug effectiveness between groups."}
- {"endpoint_text":"- EuroQol-5D Youth. A descriptive system for health-related quality of life states in five dimensions, plus a visual analogue scale.","definition_or_measurement_approach":"EQ-5D-Y descriptive system and VAS to assess health-related quality of life in children."}
- {"endpoint_text":"- Pediatric Quality of Life Inventory. A modular instrument aimed at measuring healthrelated quality of life in children and adolescents. It showed excellent reliability and validity in individuals with autism spectrum disorder","definition_or_measurement_approach":"PedsQL instruments to measure health-related quality of life in children and adolescents."}
- {"endpoint_text":"- Clinical Global Improvement","definition_or_measurement_approach":"Clinician-rated global improvement scale to assess overall clinical change."}
- {"endpoint_text":"- Treatment Inventory of Costs in Patients with psychiatric disorders. A modular questionnaire aimed at mapping healthcare utilization and the repercussions of psychosocial problems, allowing for the assessment of associated costs.","definition_or_measurement_approach":"TIC-P questionnaire to capture healthcare utilization and associated costs."}
- {"endpoint_text":"- Levels of glucose, cholesterol, lipoproteins and triglycerides; the hormones ghrelin, prolactin and leptin.","definition_or_measurement_approach":"Laboratory measurements of metabolic parameters (glucose, cholesterol, lipoproteins, triglycerides) and hormone levels (ghrelin, prolactin, leptin) to compare safety profiles between groups."}
- {"endpoint_text":"- Abnormal Involuntary Movement Scale, a clinician administered observational scale aimed at detecting extrapyramidal side effects.","definition_or_measurement_approach":"AIMS clinician-administered observational scale to detect extrapyramidal side effects."}
- {"endpoint_text":"- Blood pressure","definition_or_measurement_approach":"Measurement of blood pressure as a safety parameter."}
Recruitment
- Planned Sample Size
- 280
- Recruitment Window Months
- 48
- Consent Approach
- Age-specific subject information and informed consent forms are provided: ICFs/SIS for 6-11 years, 12-15 years, 16-18 years, and a parent information/consent form. Minors require parental consent and age-appropriate participant information/assent as per the provided ICF documents.
Geography
- Total Number Of Sites
- 13
- Total Number Of Participants
- 280
Netherlands
- Earliest CTIS Part Ii Submission Date
- 10-07-2024
- Latest Decision Or Authorization Date
- 16-07-2024
- Processing Time Days
- 6
- Number Of Sites
- 10
- Number Of Participants
- 250
Sites
- Site Name
- Mondriaan
- Department Name
- KJPP
- Contact Person Name
- T. van Amelsvoort
- Contact Person Email
- info@mondriaan.eu
- Site Name
- Accare
- Department Name
- KJPP
- Contact Person Name
- P. Hoekstra
- Contact Person Email
- SPACe@erasmusmc.nl
- Site Name
- GGz Breburg
- Department Name
- KJPP
- Contact Person Name
- C. van Looy
- Contact Person Email
- info@ggzbreburg.nl
- Site Name
- Erasmus MC
- Department Name
- KJPP
- Principal Investigator Name
- B. Dierckx
- Principal Investigator Email
- b.dierckx@erasmusmc.nl
- Contact Person Name
- B. Dierckx
- Contact Person Email
- SPACe@erasmusmc.nl
- Site Name
- GGZ Delfland
- Department Name
- KJPP
- Contact Person Name
- D. van Altena
- Contact Person Email
- SPACe@erasmusmc.nl
- Site Name
- Karakter
- Department Name
- KJPP
- Contact Person Name
- G. van de Loo
- Contact Person Email
- SPACe@erasmusmc.nl
- Site Name
- LUMC Curium
- Department Name
- KJPP
- Contact Person Name
- R. Vermeieren
- Contact Person Email
- SPACe@erasmusmc.nl
- Site Name
- 's Heeren Loo
- Department Name
- KJPP
- Contact Person Name
- A. van Eeghen
- Contact Person Email
- SPACe@erasmusmc.nl
- Site Name
- Yulius GGZ
- Department Name
- KJPP
- Contact Person Name
- D. Bastiaansen
- Contact Person Email
- SPACe@erasmusmc.nl
- Site Name
- Accare (additional / duplicate listing as per CTIS site list)
- Department Name
- KJPP
Germany
- Earliest CTIS Part Ii Submission Date
- 10-07-2024
- Latest Decision Or Authorization Date
- 31-07-2024
- Processing Time Days
- 21
- Number Of Sites
- 3
- Number Of Participants
- 30
Sites
- Site Name
- Wurzburg University Hospital
- Department Name
- Kinder- und Jugendpsychiatrie
- Principal Investigator Name
- Marcel Romanos
- Principal Investigator Email
- romanos_M@ukw.de
- Contact Person Name
- Marcel Romanos
- Contact Person Email
- romanos_M@ukw.de
- Site Name
- KJP Mariaberg
- Department Name
- Kinder- und Jugendpsychiatrie
- Principal Investigator Name
- Martin Menzel
- Principal Investigator Email
- m.menzel@mariaberg.de
- Contact Person Name
- Martin Menzel
- Contact Person Email
- m.menzel@mariaberg.de
- Site Name
- Tübingen University Hospital
- Department Name
- Kinder- und Jugendpsychiatrie
- Principal Investigator Name
- Gottfried Barth
- Principal Investigator Email
- gottfried.barth@med.uni-tuebingen.de
- Contact Person Name
- Gottfried Barth
- Contact Person Email
- gottfried.barth@med.uni-tuebingen.de
Sponsor
Primary sponsor
- Full Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Netherlands
Third parties
- {"country":"","full_name":"ZonMw","duties_or_roles":"Funding","organisation_type":""}
- {"country":"","full_name":"Stichting de Merel","duties_or_roles":"Funding","organisation_type":""}
- {"country":"","full_name":"Erasmus MC","duties_or_roles":"Funding","organisation_type":""}
Investigational products
- Investigational Product Name
- ARIPIPRAZOLE
- Active Substance
- ARIPIPRAZOLE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- marketingAuthNumber: '-' ; prodAuthStatus: 2
- Maximum Dose
- 10 mg (maxDailyDoseAmount 10 mg)
- Investigational Product Name
- RISPERIDONE
- Active Substance
- RISPERIDONE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- marketingAuthNumber: '-' ; prodAuthStatus: 2
- Maximum Dose
- 0.08 mg/kg (maxDailyDoseAmount 0.08 mg/kg)
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