In short
Pipamperone is a first-generation antipsychotic medicine authorised in the Netherlands as Dipiperon 40 mg tablets. It is currently being studied in a Phase 3 trial for behaviours that challenge in people with intellectual disabilities. The trial compares pipamperone with aripiprazole and with periods without antipsychotic medication in 45 participants.
Key points
- Pipamperone is a first-generation antipsychotic authorised as Dipiperon 40 mg tablets in the Netherlands.
- The EPABID trial is a Phase 3 study in behaviours that challenge in intellectual disability.
- The trial enrols 45 participants and is currently authorised.
- Pipamperone is compared with aripiprazole and with periods without antipsychotic medication.
- The main outcome is change in the Aberrant Behavior Checklist–Irritability score over time.
- Pipamperone is given as an oral tablet.
What is pipamperone?
Pipamperone is a chemically synthesised substance classified as an antipsychotic.
How does pipamperone work?
Pipamperone belongs to the butyrophenone class of antipsychotics. Antipsychotics in this class act on dopamine receptors in the brain, which is thought to be how they reduce symptoms such as agitation and irritability. A population pharmacokinetic study in children and adolescents describes pipamperone as a medicine for which the relationship between blood levels, effectiveness and side effects has been investigated, with the goal of understanding how the drug behaves in the body over time. The study does not state a single molecular target in the excerpt provided, but it places pipamperone within antipsychotic treatment and examines how its concentration relates to clinical response and adverse effects.
Which conditions is pipamperone used or studied for?
- Behaviours that challenge in intellectual disability — the EPABID trial studies whether pipamperone reduces the severity of behaviours that challenge in people with an intellectual disability.
- Psychiatric conditions in children and adolescents — a pharmacokinetic study reports pipamperone use in children and adolescents, describing effectiveness and side effects in this population.
How is pipamperone given?
Pipamperone is given by mouth as a tablet. In the EPABID trial the product used is Dipiperon 40 mg tablets, and the intervention description lists an oral dose of 120 mg per day. The pharmaceutical form recorded in the trial registry is a tablet for oral use.
What do the clinical trials show?
One trial is registered for pipamperone in the EU Clinical Trials Information System. The EPABID trial is a Phase 3 interventional study that enrols 45 participants with behaviours that challenge in the context of intellectual disability. The trial is currently authorised, meaning it has received approval to proceed. The study compares pipamperone with aripiprazole and with periods during which participants receive neither drug nor any other antipsychotic medication. The primary outcome is the severity of behaviours that challenge over time, measured with the Aberrant Behavior Checklist–Irritability subscale, under pipamperone compared with a period without pipamperone, and under aripiprazole compared with a period without aripiprazole.
What side effects are known?
A population pharmacokinetic study in children and adolescents reports that pipamperone has been examined for side effects in relation to its concentration in the blood. The excerpt provided does not list individual side effects, so no specific adverse reactions can be reported here.