AuthorisedTherapeutic use (Phase IV)Interventional

The efficacy of pipamperone and aripiprazole on behaviors that challenge in people with intellectual disabilities: A series of N-of-1 cross-over trials

This research is investigating two medicines, pipamperone and aripiprazole, to see how effectively they help people with learning disabilities who experience challenging behaviours. The study design involves carefully comparing periods when someone is taking one of these medicines with periods when they are not, for each individual. Researchers will measure changes in behavior severity over time using special checklists. They will also look at other important things like quality of life, daily functioning, and any side effects. This helps us understand if and how these medications can improve the lives of individuals and their carers.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Stichting GGZ Drenthe

Enrolment target

Start

28 Jan 2026

Behaviors that challenge

What is this study about?

This study is designed to understand if two specific medicines, pipamperone and aripiprazole, can help people with learning disabilities who show challenging behaviours. Challenging behaviours can be anything that makes it hard for someone to live a full life, such as being very irritable or acting out. The main goal is to see if taking these medicines reduces how severe these behaviours are.

To do this, the researchers are using a special type of study where each person acts as their own comparison. This means they will carefully observe a person's behaviours while they are taking one of the medicines, and then compare it to how they are doing during a time when they are not taking that specific medicine. This helps to clearly see the effect of each medication on that individual.

Beyond just looking at challenging behaviours, the study also measures other important aspects. This includes how these medicines might affect a person's overall quality of life, their ability to do everyday tasks, and any potential side effects. By looking at all these factors, the study aims to give a clearer picture of whether these medicines are helpful and well-tolerated for people with learning disabilities.

Key takeaways

The study looks at two medicines, pipamperone and aripiprazole, for challenging behaviours.
It's for adults with a learning disability who experience these behaviours.
Each person will try periods with medication and periods without, allowing for direct comparison.
Researchers will check how behaviours, quality of life, and daily activities change.
Side effects will also be closely monitored to ensure safety.
The aim is to find out if these medicines can make a positive difference for individuals.

Who may be eligible?

This study is for adults, aged 18 and over, who experience challenging behaviours and have a learning disability. Both men and women can take part.

Before joining, a healthcare professional will check if the study is suitable for you or the person you care for. They will make sure you meet all the necessary requirements to ensure your safety and that the study can gather useful information.

Quick self-check

Are you 18 years old or older?
Do you have a learning disability?
Do you experience challenging behaviours?
Are you willing to take specific study medicines and have periods without them?
Can you attend regular appointments for assessments?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you will take either pipamperone or aripiprazole for certain periods, followed by periods without the medicine, and then switch to the other medicine. This is a "cross-over" study, meaning you will try both medicines and periods without.

You will have regular appointments where healthcare staff will ask questions about behaviours and how you are feeling, using special checklists. They will also ask about your quality of life, how you manage daily tasks, and any side effects. The study will involve several visits over a period, and during some parts, electronic diaries might be used to record behaviours. The total duration of participation will depend on the study's design for each individual, but it will involve alternating periods with and without medication.

Potential risks and benefits

Taking part in a study might offer potential benefits, such as gaining access to specific treatments that may or may not be helpful for your condition, and contributing to medical knowledge that could help others in the future. However, there are also potential risks, including experiencing side effects from the medications, which will be monitored closely. You might also find the study visits or assessments time-consuming. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

—
Netherlands

Common questions

What are "challenging behaviours"?

These are behaviours that can make it difficult for someone to live a full life, such as being very irritable, acting out, or repetitive actions.

What are pipamperone and aripiprazole?

These are types of medicines that can sometimes be used to help manage certain behaviours, particularly in people with conditions like learning disabilities.

Will I have to stop my current medications?

The study team will discuss all your current medications and determine if any changes are needed for the study. This will be explained clearly before you agree to participate.

How long will I be in the study?

The exact duration for each person will be explained by the study team, as it involves different periods with and without medication.

Can I leave the study at any time?

Yes, you are free to leave the study at any point, for any reason, and it will not affect your usual medical care.