Withdrawing off-label antipsychotics in people with intellectual disabilities: why does it fail?

Phase 3

Recruiting

• Conditions: gedragsproblemen bij mensen met een verstandelijke beperking; people with intellectual disablity and challenging behavior; 10037173

• Registration Number: NL-OMON55806
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 122

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 >
one year (minimal dosage of 0,2 mg risperidone or 8 mg pipamperone at a time)
ZZP >3

Exclusion Criteria

On-label antipsychotic use
Active delirium >1 month
Failed antipsychotic withdrawal last 6 months
Use > 1 antipsychotic

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome of the study is the failure rate in both groups, the<br /><br>reduction group (antipsychotic withdrawal group, placebo) and the control group<br /><br>(no change in antipsychotic dose).</p><br>