Withdrawing off-label antipsychotics in people with intellectual disabilities: why does it fail?
Phase 1
- Conditions
- People with challenging behavior and off-label antipsychotic useTherapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2016-002859-19-NL
- Lead Sponsor
- Erasmus MC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 125
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1
Exclusion Criteria
On-label antipsychotic use
Active delirium <1 month
Failed antipsychotic withdrawal last 6 months
Use >1 antipsychotic
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method