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

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002859-19-NL

Enrollment

Unknown

Registered

2016-09-20

Start date

2017-08-22

Completion date

Unknown

Last updated

2017-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

People with challenging behavior and off-label antipsychotic use

Interventions

Trade Name: Risperidone Product Name: Risperidone Pharmaceutical Form: Oral liquid Pharmaceutical form of the placebo: Oral liquid Route of administration of the placebo: Oral use Trade Name: Pipampe

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adults, >18 years Intellectual disability, IQ 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

Exclusion criteria: On-label antipsychotic use Active delirium 1 antipsychotic

Design outcomes

Primary

Measure	Time frame
Main Objective: 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.;Secondary Objective: 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. ;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 ;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.	—

Measure

Time frame

Main Objective: 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.;Secondary Objective: 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. ;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 ;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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Secondary

Measure	Time frame
Secondary end point(s): - CYP polymorphism - specific devices for measuring for dyskinesia, bradykinesia and akathisia VERSUS St. Hans Ratingscale and ARMS - physical examinations ;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.	—

Measure

Time frame

Secondary end point(s): - CYP polymorphism - specific devices for measuring for dyskinesia, bradykinesia and akathisia VERSUS St. Hans Ratingscale and ARMS - physical examinations ;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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Countries

Netherlands

Contacts

Public ContactDrs. J.G.A. van Hoek

Ipse de Bruggen

jan.van.hoek@ipsedebruggen.nl0031889675020

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026