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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-005451-42-NL

Enrollment

100

Registered

2008-10-02

Start date

2009-01-13

Completion date

Unknown

Last updated

2025-01-07

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

Conditions

Mental retardation

Interventions

Pharmaceutical Form: Capsule*

Eligibility

Sex/Gender

All

Inclusion criteria

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. 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To critically investigate whether there is an indication for long term use of antipsychotic agents prescribed for behavioral symptoms in patients with mental retardation, or if this medication may be safely discontinued, without deterioration of behavioral symptoms;Secondary Objective: To evaluate the degree of reversibility upon discontinuation of the metabolic side-effects associated with the long term use of antipsychotics. What happens with weight, sexual side-effects, glucose metabolism, lipid metabolism, and bone metabolism when patients stop taking antipsychotic agents? The identification of factors which may determine the outcome of discontinuation, including (ir)reversibility of side-effects. These possible predictors include sex, age, the cause of a patient’s mental retardation, duration of antipsychotics’ use, type of antipsychotic agent, genetic polymorphisms, level of cognitive functioning, possible presence of comorbid disorders, type of living situation (family home, group home, community home, (semi) residential setting) and social climate, and level of daily activities.;Primary end point(s): The aberrant behavior checklist (ABC), the Clinical Global Impression (CGI), and the Visual Analogue Scale (VAS).	—

Measure

Time frame

Main Objective: To critically investigate whether there is an indication for long term use of antipsychotic agents prescribed for behavioral symptoms in patients with mental retardation, or if this medication may be safely discontinued, without deterioration of behavioral symptoms;Secondary Objective: To evaluate the degree of reversibility upon discontinuation of the metabolic side-effects associated with the long term use of antipsychotics. What happens with weight, sexual side-effects, glucose metabolism, lipid metabolism, and bone metabolism when patients stop taking antipsychotic agents? The identification of factors which may determine the outcome of discontinuation, including (ir)reversibility of side-effects. These possible predictors include sex, age, the cause of a patient’s mental retardation, duration of antipsychotics’ use, type of antipsychotic agent, genetic polymorphisms, level of cognitive functioning, possible presence of comorbid disorders, type of living situation (family home, group home, community home, (semi) residential setting) and social climate, and level of daily activities.;Primary end point(s): The aberrant behavior checklist (ABC), the Clinical Global Impression (CGI), and the Visual Analogue Scale (VAS).

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Countries

Netherlands

Outcome results

None listed

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