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EPABID: Efficacy of Pipamperone and Aripiprazole on Behaviors that challenge in Intellectual Disabilities
EU CTIS ID: 2024-519833-51-00
What this study is testing
To investigate the effect of pipamperone and aripiprazole compared with a period without these agents or any other antipsychotic medication on behaviors that challenge in individuals with an intellectual disability.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- An indication for long-term care from the authorities.
- A calendar age of thirteen years or more.
- An intellectual disability of any level.
- A minimum of severity of behaviors that challenge as measured with the Clinical Global Impression scale (CGI-S ≥2) and symptoms of irritability as measured with the Aberrant Behavior Checklist-Irritability scale (ABC-I ≥ 6).
- If sexually active, use of contraception.
- The participant’s physician has indicated that there is need to investigate whether a treatment with pipamperone or with aripiprazole for behaviors that challenge is beneficial for the participant, after shared decision making with participant’s other healthcare professionals, the care team, the participant themselves (if possible, considering participant’s competencies) and participant’s relatives and legal representative.
You likely can't join if
- A life expectancy of less than one year.
- A diagnosis of schizophrenia, chronic psychosis or bipolar disorder, which was established less than two years ago
- Use of antipsychotics at baseline.
- An absolute contra-indication for use of pipamperone or aripiprazole.
- Known allergies or intolerances of pipamperone, aripiprazole, or thiamine
- The concurrent use of medications that prolong the QT interval or those that may induce extrapyramidal side-effects.
See the full eligibility criteria
- An indication for long-term care from the authorities.
- A calendar age of thirteen years or more.
- An intellectual disability of any level.
- A minimum of severity of behaviors that challenge as measured with the Clinical Global Impression scale (CGI-S ≥2) and symptoms of irritability as measured with the Aberrant Behavior Checklist-Irritability scale (ABC-I ≥ 6).
- If sexually active, use of contraception.
- The participant’s physician has indicated that there is need to investigate whether a treatment with pipamperone or with aripiprazole for behaviors that challenge is beneficial for the participant, after shared decision making with participant’s other healthcare professionals, the care team, the participant themselves (if possible, considering participant’s competencies) and participant’s relatives and legal representative.
- A life expectancy of less than one year.
- A diagnosis of schizophrenia, chronic psychosis or bipolar disorder, which was established less than two years ago
- Use of antipsychotics at baseline.
- An absolute contra-indication for use of pipamperone or aripiprazole.
- Known allergies or intolerances of pipamperone, aripiprazole, or thiamine
- The concurrent use of medications that prolong the QT interval or those that may induce extrapyramidal side-effects.
- The concurrent use of medications that are known as CYP3A4 inhibitors and/or CYP2D6 inhibitors.
- Pregnancy.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.