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Clinical Trials/EUCTR2016-002859-19-NL
EUCTR2016-002859-19-NL
Active, not recruiting
Phase 1

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

Erasmus MC0 sitesSeptember 20, 2016
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ConditionsPeople with challenging behavior and off-label antipsychotic useTherapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
DrugsRisperidonePipamperone

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
People with challenging behavior and off-label antipsychotic use
Sponsor
Erasmus MC
Status
Active, not recruiting
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 20, 2016
End Date
TBD
Last Updated
8 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Erasmus MC

Eligibility Criteria

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
  • •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

Outcomes

Primary Outcomes

Not specified

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