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Withdrawing off-label antipsychotics in people with intellectual disabilities: why does it fail?

Project summary

Antipsychotics are often prescribed off-label for patients with mental retardation or behavioral problems such as aggression or auto-mutilation. There is no proof that this is effective, while side effects are known. Those side effects are often irreversible after reduction of the medication and often it does not work to start reducing medication.
This study will investigate why the reduction of medication does not work.
Using a double-blind placebo-controlled decline of medication of antipsychotics 2 groups of chronic users will be compared during 40 weeks. The drop-out rates of both groups will be compared as well. All participants will be diagnosed for behavioral problems, sleep problems, psychiatric problems and side effects.


The results of this study are needed for evidence-based decision making to prescribe off-label antipsychotics for mentally-retarded patients and they are needed for the development of guidelines.

More detailed information

Principal Investigator:

Dr. Dederieke Maes-Festen

Role Erasmus MC:



Project website:

Funding Agency: