ong-term use of antipsychotics for behavioral symptoms in patients with mental retardation; a controlled discontinuation study
- Conditions
- Mental retardation
- Registration Number
- EUCTR2007-005451-42-NL
- Lead Sponsor
- niversity Medical Center Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Institutionalized persons with mental retardation aged between 15-65 year currently receiving antipsychotics for behavioral symptoms for 12 months or longer are eligible. Behavioral symptoms will be defined as challenging, disruptive, or aggressive behavior to self, others, or materials, either physically or verbally, including sexually aggressive behavior.
Are the trial subjects under 18? yes
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
a) a history of schizophrenia or a bipolair disorder according to DSM IV criteria
b) a history of unsuccessful withdrawal of antipsychotics in the past 12 months.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method