ARIPIPRAZOLE for Behaviors that challenge | Abnormal behaviour

Inclusion criteria

• {"criterion_text":"- An indication for long-term care from the authorities."}
• {"criterion_text":"- A calendar age of thirteen years or more."}
• {"criterion_text":"- An intellectual disability of any level."}
• {"criterion_text":"- 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)."}
• {"criterion_text":"- If sexually active, use of contraception."}
• {"criterion_text":"- 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."}

Exclusion criteria

• {"criterion_text":"- A life expectancy of less than one year."}
• {"criterion_text":"- A diagnosis of schizophrenia, chronic psychosis or bipolar disorder, which was established less than two years ago"}
• {"criterion_text":"- Use of antipsychotics at baseline."}
• {"criterion_text":"- An absolute contra-indication for use of pipamperone or aripiprazole."}
• {"criterion_text":"- Known allergies or intolerances of pipamperone, aripiprazole, or thiamine"}
• {"criterion_text":"- The concurrent use of medications that prolong the QT interval or those that may induce extrapyramidal side-effects."}
• {"criterion_text":"- The concurrent use of medications that are known as CYP3A4 inhibitors and/or CYP2D6 inhibitors."}
• {"criterion_text":"- Pregnancy."}

Primary endpoints

• {"endpoint_text":"- The severity of behaviors that challenge over time measured with the Aberrant Behavior Checklist- Irritability (ABC-I) under treatment with pipamperone compared to a period without pipamperone, and under treatment with aripiprazole compared to a period without aripiprazole.","definition_or_measurement_approach":"Measured over time using the Aberrant Behavior Checklist - Irritability subscale (ABC-I); comparisons are between treatment periods with pipamperone or aripiprazole and periods without the respective antipsychotic."}

Secondary endpoints

• {"endpoint_text":"- The severity of behaviors that challenge over time measured on the Clinical Global Impression of Severity (CGI-S) and the Clinical Global Impression of Improvement (CGI-I) under treatment with pipamperone compared to a period without pipamperone, and under treatment with aripiprazole compared to a period without aripiprazole.","definition_or_measurement_approach":"Measured over time using CGI-S and CGI-I; comparisons between antipsychotic treatment periods and periods without antipsychotic treatment."}
• {"endpoint_text":"- The symptoms and severity of behaviors that challenge over time measured on the separate subscales of the Aberrant Behavior Checklist (ABC) under antipsychotic treatment compared to a period without antipsychotic treatment.","definition_or_measurement_approach":"Measured over time using the subscales of the Aberrant Behavior Checklist (ABC); comparisons between antipsychotic treatment periods and periods without antipsychotic treatment."}
• {"endpoint_text":"- The symptoms and severity of the targeted behaviors that challenge over time measured on the Ecological Momentary Assessments (EMA) under antipsychotic treatment compared to a period without antipsychotic treatment.","definition_or_measurement_approach":"Real-time measurements using Ecological Momentary Assessments (EMA) collected over treatment and non-treatment periods; comparison across periods."}
• {"endpoint_text":"- Quality of life measured under antipsychotic treatment compared to a period without antipsychotic treatment. The quality of life is measured over time on the Euro-QoL-5D (EQ-5D-5L).","definition_or_measurement_approach":"Measured over time using the EQ-5D-5L instrument; comparisons between antipsychotic treatment periods and periods without antipsychotic treatment."}
• {"endpoint_text":"- Daily functioning measured under antipsychotic treatment compared to a period without antipsychotic treatment. Daily functioning is measured over time on the World Health Organisation Disability Assessment Scale-12 (WHODAS-12).","definition_or_measurement_approach":"Measured over time using WHODAS-12; comparisons between antipsychotic treatment periods and periods without antipsychotic treatment."}
• {"endpoint_text":"- The severity of side effects under antipsychotic treatment compared to a period without antipsychotic treatment. Side effects are measured over time with the Matson Evaluation Drug Side-effects (MEDS).","definition_or_measurement_approach":"Measured over time using the Matson Evaluation Drug Side-effects (MEDS) instrument; comparisons across treatment and non-treatment periods."}
• {"endpoint_text":"- The correlation between the severity of targeted behavioral symptoms measured on the Ecological Momentary Assessment (EMA) and the severity of behaviors that challenge measured on the Clinical Global Impression scale (CGI) and the Aberrant Behavior Checklist (ABC) after each treatment period.","definition_or_measurement_approach":"Correlation analysis between EMA outcomes and CGI/ABC scores after each treatment period."}
• {"endpoint_text":"- The frequency of rescue medication under antipsychotic treatment compared with a period without antipsychotic treatment. These data are measured over time with the interval history.","definition_or_measurement_approach":"Frequency of rescue medication use recorded over time using interval history; comparisons between antipsychotic treatment periods and non-treatment periods."}

Netherlands

Earliest CTIS Part Ii Submission Date

19-12-2025

Latest Decision Or Authorization Date

03-04-2026

Processing Time Days

105

Number Of Sites

4

Number Of Participants

45

Primary sponsor

Full Name

Stichting GGZ Drenthe

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands