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Study of pipamperone and aripiprazole for challenging behaviors in people with intellectual disabilities

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 study is looking at behaviors that challenge in people with intellectual disabilities. Behaviors that challenge are difficult or disruptive behaviors that can affect the person and those around them. The study will examine two medications: pipamperone and aripiprazole. Both of these are medications that are sometimes used to help manage challenging behaviors. The study will also include periods when the person is not taking these medications or any other similar medications. Additionally, a medication called thiamine hydrochloride, which is a form of vitamin B1, will be used in the study.

The purpose of the study is to find out whether pipamperone and aripiprazole are helpful in reducing behaviors that challenge when compared to periods without these medications. The study wants to see if these treatments actually make a difference for individuals with intellectual disabilities who experience these behaviors.

During the study, participants will go through different treatment periods where they will take either pipamperone, aripiprazole, or no antipsychotic medication at all. These periods will alternate so that comparisons can be made between when the person is taking medication and when they are not. Throughout the study, the severity of challenging behaviors will be measured regularly using various assessment tools. The study will also look at quality of life, daily functioning, and any side effects that might occur. The study is expected to last about eleven weeks for each participant, and measurements will be taken at different times to see how the behaviors change during each treatment period.

The research process

The trial runs in 10 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment period

    The trial follows a crossover design, which means different treatment periods will be alternated. Each period will be evaluated to compare the effects of different medications on challenging behaviors.

    During the trial, there will be periods when medication is taken and periods without any antipsychotic medication. The order of these periods may vary.

  2. Step 2

    Treatment with pipamperone

    During this period, pipamperone will be taken orally in tablet form. The specific dosage and frequency will be determined individually.

    Pipamperone is an antipsychotic medication used to help manage challenging behaviors.

    The duration of this treatment period will be specified according to the individual treatment plan.

  3. Step 3

    Treatment with aripiprazole

    During this period, aripiprazole will be taken orally in tablet form. The specific dosage and frequency will be determined individually.

    Aripiprazole is an antipsychotic medication used to help manage challenging behaviors.

    The duration of this treatment period will be specified according to the individual treatment plan.

  4. Step 4

    Period without antipsychotic medication

    During this period, no antipsychotic medication will be taken. This allows for comparison of how challenging behaviors present with and without medication.

    This period is an essential part of determining which treatment approach is most beneficial.

  5. Step 5

    Supportive medication

    Thiamine hydrochloride (vitamin B1) will be taken orally in tablet form throughout the trial as supportive treatment.

    This vitamin supplement is provided to support overall health during the trial.

  6. Step 6

    Assessment of challenging behaviors

    Throughout all treatment periods, challenging behaviors will be regularly assessed using standardized scales.

    The Aberrant Behavior Checklist will be used to measure irritability and other behavioral symptoms.

    The Clinical Global Impression scale will be used to assess the overall severity and improvement of symptoms.

    Ecological Momentary Assessments will be conducted to track specific targeted behaviors in real-time throughout the day.

  7. Step 7

    Quality of life and daily functioning assessments

    Quality of life will be measured throughout the trial using the EuroQoL-5D questionnaire.

    Daily functioning will be assessed using the World Health Organisation Disability Assessment Scale.

    These assessments help determine how the different treatment periods affect overall wellbeing and ability to perform daily activities.

  8. Step 8

    Side effects monitoring

    Any side effects experienced during each treatment period will be monitored and recorded using the Matson Evaluation of Drug Side-effects scale.

    This monitoring helps compare the tolerability of different treatment approaches.

  9. Step 9

    Rescue medication tracking

    If additional medication is needed during any treatment period to manage acute symptoms, this will be recorded.

    The frequency of such rescue medication use will be compared across different treatment periods.

  10. Step 10

    Comparison of treatment periods

    After completing all treatment periods, the results will be analyzed to determine which approach is most effective for managing challenging behaviors.

    The comparison will consider the severity of behaviors, quality of life, daily functioning, side effects, and need for additional medication.

    This individualized approach helps identify the most beneficial treatment for each participant.

Who can join the trial?

7 criteria

  • You must have approval for long-term care from the authorities.
  • You must be thirteen years old or older.
  • You must have an intellectual disability, which means having difficulties with learning, understanding, and thinking skills, at any level of severity.
  • You must have challenging behaviors that are at least moderate in severity, as measured by a scale called the Clinical Global Impression scale, which is a tool doctors use to rate how severe your symptoms are.
  • You must show signs of irritability, which means being easily upset, annoyed, or angry, with a score of at least 6 on a scale called the Aberrant Behavior Checklist-Irritability scale.
  • If you are sexually active, you must use contraception, which means methods to prevent pregnancy.
  • Your doctor must have decided, together with your healthcare team, care team, yourself if possible, your relatives, and your legal representative, which is a person who has the legal right to make decisions on your behalf, that it is important to find out if treatment with pipamperone or aripiprazole, which are medications used to help manage challenging behaviors, would be helpful for you.

Who cannot join the trial?

5 criteria

  • The study does not list specific reasons why patients cannot participate
  • Your doctor will need to evaluate if this study is appropriate for you based on your individual medical situation
  • General safety considerations will be reviewed by the research team before you can join
  • Certain medications, which are substances used to treat illnesses, may affect whether you can participate
  • Your current health conditions will be carefully assessed to ensure the study is safe for you
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Investigated drugs

  • Pipamperone

    is an antipsychotic medication that is being tested in this study to see if it can help reduce challenging behaviors in people with intellectual disabilities.

  • Aripiprazole

    is an antipsychotic medication that is being tested in this study to see if it can help reduce challenging behaviors in people with intellectual disabilities.

What is already known about the treatment

  • Pipamperone

    Pipamperone is an antipsychotic medication that is typically taken by mouth in tablet form and is used to manage challenging behaviors in people with intellectual disabilities. It works by blocking certain receptors in the brain, specifically dopamine and serotonin receptors, which helps to calm agitation and reduce aggressive or disruptive behaviors. This medication belongs to a class of drugs called typical antipsychotics and has been studied in clinical trials to evaluate its effectiveness in controlling difficult behaviors when compared to periods without medication.

  • Aripiprazole

    Aripiprazole is an antipsychotic medication available in various forms including tablets, liquid solution, and injections, and is prescribed to help manage challenging behaviors in individuals with intellectual disabilities. It works differently from older antipsychotics by partially activating dopamine receptors in the brain while also affecting serotonin receptors, which helps balance brain chemistry and reduce behavioral problems. This medication is classified as an atypical or second-generation antipsychotic and is being evaluated in research studies to determine how well it controls disruptive behaviors compared to not using any antipsychotic treatment.

Investigated diseases

Intellectual Disability – Intellectual disability is a condition characterized by significant limitations in intellectual functioning and adaptive behavior. It affects a person's ability to learn, reason, solve problems, and adapt to new situations. The condition begins during the developmental period, typically before adulthood. People with intellectual disability may have difficulty with communication, self-care, and social skills. The severity can range from mild to profound, affecting how independently a person can function in daily life. Individuals with this condition may also experience behavioral challenges that require specialized support and care.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-519833-51-00Protocol code2024-519833-51-00Estimated enrolment45 patientsSponsorStichting GGZ Drenthe

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