EPABID: Efficacy of Pipamperone and Aripiprazole on Behaviors that challenge in Intellectual Disabilities

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Stichting GGZ Drenthe

Participant type

Pediatric, Patients

Age range

0-17 years, 18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04], Psychiatry and Psychology [F] - Mental Disorders [F03]

Decision date (initial)

2026-01-28

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

ZonMW 11070012310002

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy

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.

Secondary objectives 3

1. To investigate the effect of pipamperone and aripiprazole on specific types of behaviors that challenge or on clusters of behavioral symptoms.
2. To investigate daily functioning, quality of life and effects of treatment with pipamperone and aripiprazole among individuals with intellectual disability.
3. To investigate the relationship between the outcomes of the momentary assessment measurements (EMA) and the outcomes of the generic Clinical Global Improvement instrument (CGI) and the population-specific instrument for the measurement of the symptoms of behaviors that challenge (Aberrant Behavior Checklist).

Conditions and MedDRA coding

Behaviors that challenge

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. An indication for long-term care from the authorities.
2. A calendar age of thirteen years or more.
3. An intellectual disability of any level.
4. 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).
5. If sexually active, use of contraception.
6. 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 8

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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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.

Secondary endpoints 8

1. 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.
2. 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.
3. 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.
4. 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).
5. 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).
6. 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).
7. 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.
8. 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.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Stichting GGZ Drenthe

Sponsor organisation

Stichting GGZ Drenthe

Address

Dennenweg 9

City

Assen

Postcode

9404 LA

Country

Netherlands

Scientific contact point

Organisation

Stichting GGZ Drenthe

Contact name

Research CVBP

Public contact point

Organisation

Stichting GGZ Drenthe

Contact name

Research CVBP

Locations

1 EU/EEA country · 4 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 21 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications