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Patients with schizophrenia barely represented in antipsychotic drug studies

As many as 80% of patients who are sensitive to psychosis are not allowed to participate in clinical studies into the effectiveness of antipsychotics. Such drug studies use such strict exclusion criteria that only the least ill patients can participate in the study.

Think of people who are sensitive to psychosis, but who do not suffer from addictions, physical illnesses or suicidal thoughts. Moreover, it appears that people with a sensitivity to psychosis who do suffer from addictions, physical illnesses or suicidal thoughts, for example, respond worse to antipsychotics than the less ill patients.

This emerges from international research led by Maastricht University (UM). The striking findings were published in the scientific journal JAMA Psychiatry.


For this study, the international research team used large-scale medical registries from Scandinavia dating back decades. In Sweden and Finland, meticulous records have been kept for decades with which disease patients report to psychiatrists.

The scientists then compared data from tens of thousands of patients from these national registries – which are about the patient in the doctor’s office – next to the exclusion criteria that clinical studies of antipsychotics use when including subjects. Exclusion criteria are, for example, ‘suicidal tendencies’, ‘suffering from physical illness’ or ‘addicted to drugs or medication’.

Both the Swedish and Finnish registries showed that four out of five patients who are prone to psychosis who visit a psychiatrist in the consultation room are not eligible to participate in clinical trials of drugs against psychosis (antipsychotics).

clinical studies

In addition, the researchers were able to deduce from the Scandinavian data that the most complex cases are more likely to develop a serious illness when they receive antipsychotics than psychosis-prone people who do not suffer from addictions, physical illnesses or suicidal thoughts.

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Lead researcher and psychiatrist Jurjen Luykx argues for greater inclusiveness in large clinical studies. And for more specific studies in certain patient groups who are regularly seen in the doctor’s office, such as people who are psychotic and addicted.

“Our findings show that little is actually known about the best treatment for the most common patient with psychosis sensitivity in the doctor’s office”, said Luykx. “That is the person who is also prone to addiction, suicidal thoughts or physical illnesses. As a psychiatrist I see many people with a psychotic vulnerability and these kinds of additional complaints. It is essential to know which treatment works well for these people, because we often see them in our consulting rooms. That is why we need to be much more inclusive in scientific research into new drugs for people with psychosis sensitivity in the future.”

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