Research Topic

Defining a Patient-Centered Use of Antipsychotic Drugs: From Efficacy and Safety to Effectiveness and Tolerability

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Antipsychotic drugs are among the main pharmacological tools currently used to treat a variety of mental disorders. These disorders can vary based on the type of disorder and on the age of patients, ranging for instance from schizophrenia in adults, to irritability in children.

Efficacy and safety ...

Antipsychotic drugs are among the main pharmacological tools currently used to treat a variety of mental disorders. These disorders can vary based on the type of disorder and on the age of patients, ranging for instance from schizophrenia in adults, to irritability in children.

Efficacy and safety parameters of antipsychotics usually come from clinical trials conducted in selected populations with one or two mental disorders and of adult age. Therefore, such information cannot be considered directly valid for all indications and for all patient-age categories, due to the extraordinarily wide spectrum of use of antipsychotics. In practical terms, the needs of a 70-year old patient with Alzheimer’s disease are incredibly different from the needs of a 7-year old patient with an Autism-spectrum disorder and irritability, although both can be efficaciously treated with risperidone.

In this scenario of extreme variability, it is important to find the roots of efficacy and safety. The theory of occupation of D2 receptors had set the bases for antipsychotics use in schizophrenia and psychoses for positive symptoms. In fact, we still need to explore which are the pharmacological determinants of antipsychotic efficacy and safety in other disorders and ages. Is it always dopamine? Is it serotonin, histamine, noradrenaline? At what concentrations are they efficacious and safe? Can we believe that therapeutic ranges for schizophrenia are valid also for mania, or even for irritability? In parallel, caregivers are crucial for determining the effectiveness and tolerability of antipsychotics in daily life. Clinical trials are just beginning to appraise this issue, while observational studies can already provide precious indications and guidance to improve the use of antipsychotics, which deserve attention.

In conclusion, there is currently a need to re-define the pharmacodynamic and pharmacokinetic bases of a patient-centered use of antipsychotics, which must be able to meet the requirements of effectiveness and tolerability set by patients and by their caregivers, in order to allow compliance to long-term therapies.

For this Research Topic, we welcome studies focused on the clinical aspects of the efficacy/effectiveness and safety/tolerability of antipsychotic drugs. It is important that studies focus on specific indications of use and specific age groups, as the topic is centered on the heterogeneous needs of patients who are currently exposed to antipsychotics.

This topic privileges work on children and adolescents, as they are a fragile population on which clinical trials are scant. However, work on adult populations with “infrequent” conditions is also welcome, for instance, work concerning the elderly, or adult patients with comorbid affections that are not plain schizophrenia or psychosis or mania.

Work of interest to this topic may include:
- experimental studies (studying molecular mechanisms, or preclinical pharmacokinetics or pharmacodynamics);
- observational (i.e. non-interventional) clinical studies;
- clinical trials (i.e. interventional);
- pharmacological data mining studies, pharmacovigilance studies, that have patients' or caregivers’ perspectives as the main target;
- meta-analyses or systematic reviews with a focus on special populations
Case studies and small clinical studies (n<20) are not of interest.


Keywords: Antipsychotic Drugs, Pharmacokinetics, Safety, Tolerability, Pharmacodynamics, Effectiveness, Efficacy


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