A placebo-controlled discontinuation trial of off-label used risperidone in people with intellectual disability

Phase 4

Completed

Conditions: behavioral problems
Challenging behavior
10037173

Registration Number: NL-OMON43644

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

1. IQ lower then 70 as assessed by an authorized behavioral therapist
2. Age over 6 years
3. No history of chronic psychosis
4. Risperidone use over1 year
5. Challenging behavior was the reason of prescription of risperidone
6. Informed consent obtained from legal representative

Exclusion Criteria

1. A history of schizofrenia, a bipolar disorder, or affective psychosis according to DSM IV or ICD-10 criteria
2. A history of unsuccessful withdrawal of antipsychotics in the past 6 months
3. The use of other antipsychotics in addition to risperidone use
4. Risperidone is administered as long-acting injections
5. Clients that do not receive 24 hour/a day care (by either a service provider or parents/family)
6. Clients that are pregnant or intention to become pregnant

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary end point is behaviopr meassured by the irritability subscale of<br /><br>the Aberrant Behaviour Checklist (ABC). The ABC was developed to<br /><br>assess (pharmaceutical) treatment effects on the challenging behaviors of<br /><br>people with intellectual disability (35-37). The ABC has 58 items divided over<br /><br>five subscales i.e., irritability (15 items), lethargy (16 items), stereotypic<br /><br>behavior (7 items), hyperactivity (16 items) and inappropriate speech (4<br /><br>items).</p><br>

Secondary Outcome Measures