off-label use of risperidone in people with intellectual disability: A discontinuation study

Phase 1

• Conditions: no specific condition, we will investigate people with intellectual disability who have been using risperidone on an off-label basis for at least one year.; Therapeutic area: Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04]

• Registration Number: EUCTR2014-003718-10-NL
• Lead Sponsor: MCG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-09
• Last Update Posted: 18 June 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

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

Are the trial subjects under 18? yes
Number of subjects for this age range: 20
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 95
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified