ong-term use of antipsychotics for behavioral symptoms in patients with mental retardation; a controlled discontinuation study

Phase 4

Completed

• Conditions: mental retardation; intellectual disability; 10034726

• Registration Number: NL-OMON32602
• Lead Sponsor: niversitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

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.

Exclusion Criteria

a) a history of schizophrenia, a bipolar disorder, or affective psychosis according to DSM IV criteria and b) a history of unsuccessful withdrawal of antipsychotics in the past 6 months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome measure will be the proportion of people developing marked<br /><br>behavioral symptoms calling for prescription of (higher doses of)<br /><br>antipsychotics and thus leading to study withdrawal in both treatment groups. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Weight, middle circumference, BMI, fasting glucose, fasting triglyceride, total<br /><br>cholesterol, HDL-and LDL-cholesterol, prolactin, CTX, P1NP, the Clinical Global<br /><br>Impression (CGI), and the Visual Analogue Scale (VAS). Extrapyramidal symptoms<br /><br>(AIMS), autonomic dysfunction (SCOPA-AUT).</p><br>