title: [How to evaluate side effects in a clinical trial?]
abstract: Adverse effects of psychotropic medications must be systematically assessed during a clinical trial. This systematic and mandatory evaluation, for the patient safety first, will also allow to establish for the tested molecule, an efficiency/tolerance ratio which could be compared to preexisting medications, and guide the clinician prescriptions. These side effects are closely related to the pharmacological profile of the tested molecule, in particular its monoamine binding profile. Antipsychotics are taken as an example, with a focus on classical clinical side effects related to each monoamine transmission blocking.
authors.affiliation: SHU Psychiatrie Adultes, Hôpital Sainte Marguerite, 13274 Marseille Cedex 9, France. Electronic address: muriele.maurel@ap-hm.fr.
authors.forename: M
authors.initials: M
authors.lastname: Maurel
authors.affiliation: SHU Psychiatrie Adultes, Hôpital Sainte Marguerite, 13274 Marseille Cedex 9, France.
authors.forename: R
authors.initials: R
authors.lastname: Belzeaux
authors.affiliation: SHU Psychiatrie Adultes, Hôpital Sainte Marguerite, 13274 Marseille Cedex 9, France.
authors.forename: M
authors.initials: M
authors.lastname: Adida
authors.affiliation: SHU Psychiatrie Adultes, Hôpital Sainte Marguerite, 13274 Marseille Cedex 9, France.
authors.forename: J-M
authors.initials: JM
authors.lastname: Azorin
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000592:standards; D015306:Biogenic Monoamines / Q000378:metabolism; D002986:Clinical Trials as Topic / Q000379:methods* / Q000706:statistics & numerical data; D064420:Drug-Related Side Effects and Adverse Reactions / Q000175:diagnosis*; D006801:Humans; D007049:Iatrogenic Disease; D011619:Psychotropic Drugs / Q000009:adverse effects*; D018570:Risk Assessment; D012720:Severity of Illness Index; D016903:Drug Monitoring
chemical_list: D015306:Biogenic Monoamines; D011619:Psychotropic Drugs
keywords: Action on monoamine systems; Action sur les systèmes; Clinical trials; Effets indésirables; Essai clinique; Evaluation methods; Modalités d’évaluation; Psychotropes; Psychotropic médication; Side effects; monoaminergiques