E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
People with challenging behavior and off-label antipsychotic use |
Mensen met een verstandelijke beperking en gedragsproblemen waarvoor offlabel antipsychotica gebruik |
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E.1.1.1 | Medical condition in easily understood language |
People with challenging behavior and off-label antipsychotic use |
Mensen met een verstandelijke beperking en gedragsproblemen waarvoor offlabel antipsychotica gebruik |
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E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Mental Disorders [F03] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To investigate why withdrawal of off-label antipsychotics for challenging behavior and intellectual disability is (often) not successful, by comparing two blinded groups of antipsychotic users of which only one is actually decreasing their AP. |
Onderzoeken waarom afbouw van off-label antipsychotica voor gedragsproblemen bij mensen met een verstandelijke beperking vaak niet succesvol verloopt door 2 geblindeerde groepen te vergelijken waarvan 1 het antipsychoticum daadwerkelijk afbouwt. |
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E.2.2 | Secondary objectives of the trial |
To investigate patient characteristics that predict outcome of the withdrawal study.
To evaluate whether in measuring drug induced movement disorders the use of electronic devices is superior to clinical rating scales.
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Onderzoeken of bepaalde patientkarakteristieken de uitkomst van de afbouw kunnen voorspellen.
Onderzoeken of bewegingsstoornissen gemeten met speciale instrumenten beter zijn vergeleken met de klinische schalen.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Adults, >18 years
Intellectual disability, IQ<70
Living at one of the participating care-organisations
Off-label use of risperidone or pipamperone because of challenging behavior > half year
ZZP>3
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Volwassenen, leeftijd ≥ van 18 jaar
Verstandelijke beperking, IQ < 70
Woonachtig binnen een van de deelnemende zorgorganisaties (Abrona, Amarant, Ipse de Bruggen)
Gebruik risperidon of pipamperon voor gedragsproblematiek langer dan een half jaar
Zorgzwaartepakket inclusief behandeling (ZZP>3)
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E.4 | Principal exclusion criteria |
On-label antipsychotic use
Active delirium <1 month
Failed antipsychotic withdrawal last 6 months
Use >1 antipsychotic
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On-label antipsychotica gebruik, dus met een juiste indicatie
Actieve diagnose delier afgelopen maandag
Een mislukte antipsychoticumafbouw afgelopen half jaar
Gebruik van >1 antipsychoticum
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary outcome measures are: interpretation of behavior, challening behavior, psychiatric disorders, circadiane rhythm problems, movement disorders and physical symptoms. They will be measured as follows:
1. Challenging behavior:
- Semi-structured interview
- ABC
- VAS
- CGI
2. Psychiatric disorders:
- ADESS
- PAS-ADD
3. Circadiane rhythm problems:
- Actigraphy
- Somnography
4. Movement disorders:
- specific devices for measuring: dyskinesia, bradykinesia and akathisia
- St. Hans Ratingscale and ARMS
5. Withdrawal symptoms and side effects:
- MEDS interview
- Physical examination
- Laboratory investigation
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De primaire uitkomstmaten zijn onder te verdelen in interpretatie van gedrag door betrokkenen/begeleiding, gedragsproblematiek, psychiatrische stoornissen, circadiaan ritme, bewegingsstoornissen en lichamelijke factoren. Ze worden gemeten worden met:
1. Gedragsproblematiek:
- Semi-gestructureerde interview
- ABC/AGS
- VAS
- CGI
2. Psychiatrische stoornissen:
- ADESS
- PAS-ADD
3. Circadiaan ritme:
- Actigrafie
- Somnografie
4. Bewegingsstoornissen:
- specifieke meetinstrumenten (dyskinesie, bradykinesie en akathisie meter)
- klinische scoringsinstrumenten: St. Hans Ratingscale en ARMS
5. Afbouwverschijnselen/onttrekkingsverschijnselen en andere bekende bijwerkingen
- MEDS interview
- Lichamelijk onderzoek
- Laboratorium onderzoek
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Most assessments will be performed at baseline and 2 and 4 weeks after each dose reduction and during follow-up (at 22 and 40 weeks). Some assessments (sleep with somnography and rating scales and electronic devices for diagnosing movement disorders) will be performed less frequently, to minimize the burden on patients.
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De meeste metingen zullen verricht worden op baseline en elke 2 en 4 weken na elke afbouwstap en gedurende de follow-up (week 22 en 40). Sommige metingen (somnografie en metingen van bewegingsstoornissen) zullen minder frequent worden verricht om de belasting van de patient te beperken.
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E.5.2 | Secondary end point(s) |
- CYP polymorphism
- specific devices for measuring for dyskinesia, bradykinesia and akathisia VERSUS St. Hans Ratingscale and ARMS
- physical examinations
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- CYP polymorphism
- specific devices for measuring for dyskinesia, bradykinesia and akathisia VERSUS St. Hans Ratingscale and ARMS
- physical examinations
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Most assessments will be performed at baseline and 2 and 4 weeks after each dose reduction and during follow-up (at 22 and 40 weeks). Some assessments (sleep with somnography and rating scales and electronic devices for diagnosing movement disorders) will be performed less frequently, to minimize the burden on patients.
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De meeste metingen zullen verricht worden op baseline en elke 2 en 4 weken na elke afbouwstap en gedurende de follow-up (week 22 en 40). Sommige metingen (somnografie en metingen van bewegingsstoornissen) zullen minder frequent worden verricht om de belasting van de patient te beperken.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 10 |