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Studying the Safety of Aripiprazole and Risperidone in Children and Adolescents with Autism Spectrum Disorder

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of two medications, aripiprazole and risperidone, in children and adolescents diagnosed with autism spectrum disorder. These medications are commonly used to help manage behavioral problems associated with autism. The purpose of the study is to explore how monitoring the levels of these medications in the body can help reduce or prevent side effects, particularly weight gain, which is a common concern with these treatments.

Participants in the study will be divided into two groups. One group will receive dosing advice based on therapeutic drug monitoring, which means their medication levels will be regularly checked to adjust the dose as needed. The other group will receive the standard care, where the medication is given according to usual clinical practices without additional monitoring. The study will observe changes in body weight and other health indicators over a period of six months, with some assessments continuing up to twelve months.

Throughout the study, various health aspects will be evaluated, including changes in body mass index (BMI), behavior, quality of life, and any side effects. The study will also monitor levels of certain substances in the blood, such as glucose and cholesterol, and check for any involuntary movements. This research aims to provide valuable insights into how these medications can be used more effectively and safely in young individuals with autism spectrum disorder.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Eligibility for participation includes being between 6 to 18 years old, having a documented clinical diagnosis of autism spectrum disorder with behavioral problems, and starting treatment with either risperidone or aripiprazole.

  2. Step 2

    Medication administration

    Participants will receive either risperidone or aripiprazole orally. The specific dosage and frequency will be determined based on therapeutic drug monitoring or standard clinical care.

  3. Step 3

    Monitoring and assessments

    The primary focus is on monitoring changes in body mass index z-scores (BMI-Z) after 6 months of treatment.

    Secondary assessments include changes in BMI-Z after 12 months, behavior checklists, quality of life inventories, clinical improvement evaluations, and healthcare utilization assessments.

    Additional health parameters such as glucose, cholesterol, hormone levels, and blood pressure will be monitored.

  4. Step 4

    Duration of the trial

    The trial is expected to conclude by November 30, 2025. Participants will be involved in the study for a period that includes initial treatment and follow-up assessments.

Who can join the trial?

4 criteria

  • Age between 6 and 18 years old.
  • Have a documented clinical diagnosis of autism spectrum disorder. This means a doctor has confirmed that the person has autism, which is a condition affecting how a person communicates and interacts with others.
  • Have additional behavioral problems. This means having challenges with behavior that may need special attention or treatment.
  • Be starting treatment with either risperidone or aripiprazole. These are medications used to help manage symptoms in people with autism.
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Investigated drugs

  • Risperidone

    is a medication used to treat certain mental and mood disorders, such as schizophrenia and bipolar disorder. In this clinical trial, it is being studied to understand its effects on children and adolescents, particularly focusing on weight gain as a side effect. The trial aims to see if monitoring the drug levels in the body can help reduce these side effects.

  • Aripiprazole

    is another medication used to treat mental and mood disorders, including schizophrenia and bipolar disorder. Similar to risperidone, this trial is examining its use in children and adolescents to see if monitoring the drug levels can help manage side effects like weight gain. The study compares standard dosing with dosing adjusted based on therapeutic drug monitoring.

What is already known about the treatment

  • Risperidone

    Risperidone is an antipsychotic medication administered orally, typically in the form of tablets or liquid. It is currently used in medical practice and literature for managing symptoms of autism spectrum disorder, particularly in children and adolescents. The medication works by altering the activity of certain neurotransmitters in the brain, primarily dopamine and serotonin, to help reduce symptoms such as irritability and aggression. Risperidone is classified as an atypical antipsychotic, and its use is being studied to optimize dosing through therapeutic drug monitoring to minimize side effects like weight gain.

  • Aripiprazole

    Aripiprazole is an antipsychotic drug that is usually taken orally, available in tablet or liquid form. It is widely recognized in medical literature and practice for treating symptoms associated with autism spectrum disorder in young patients. The drug functions by modulating the activity of neurotransmitters, particularly dopamine and serotonin, to help manage symptoms such as irritability. Aripiprazole is categorized as an atypical antipsychotic, and current studies are exploring the benefits of therapeutic drug monitoring to adjust dosing and reduce potential side effects, including weight gain.

Investigated diseases

Autism Spectrum Disorder – Autism Spectrum Disorder (ASD) is a developmental condition that affects how a person communicates and interacts with others. It is characterized by challenges with social skills, repetitive behaviors, and speech and nonverbal communication. The symptoms can vary widely in severity and may include difficulties in understanding social cues, forming relationships, and expressing emotions. Individuals with ASD may also have specific interests or engage in repetitive activities. The condition is typically identified in early childhood, and its progression can vary, with some individuals showing improvement in symptoms over time.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511568-96-00Protocol codeNL75882.078.20Estimated enrolment280 patientsSponsorErasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

sourced from the EU Clinical Trials Register and site verification

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