title: Effect of CYP2D6 on risperidone pharmacokinetics and extrapyramidal symptoms in healthy volunteers: results from a pharmacogenetic clinical trial.
abstract: OBJECTIVE
  To elucidate the relationship between CYP2D6 genotype and risperidone pharmacokinetics and extrapyramidal symptoms we propose the APSEP pharmacogenetic clinical trial.
  
  
  METHODS
  Twenty-five healthy subjects were included in this randomized, placebo-controlled, single dose (risperidone 2.5 mg) crossover and double-blind clinical trial. Subjects were selected according to their CYP2D6 genotype and classified as: poor metabolizers (n = 8), extensive metabolizers (n = 10) and ultrarapid metabolizers (n = 7).
  
  
  CONCLUSIONS
  Our study demonstrates that CYP2D6 predicted 65% of the risperidone metabolism variability. Moreover, its ability to predict actigraphy records is similar to the predictive power of pharmacokinetic parameters (24%). Our results also highlight the need for the development of pharmacogenetic predictors that take into account the complexity of pharmacokinetic and pharmacodynamic relationships.
authors: Department of Anatomic Pathology, Pharmacology & Microbiology, School of Medicine, University of Barcelona, IDIBAPS, Casanova 143, E-08036 Barcelona, Spain.
authors: Patricia
authors: P
authors: Gassó
authors: Sergi
authors: S
authors: Mas
authors: Katerina
authors: K
authors: Papagianni
authors: Eva
authors: E
authors: Ferrando
authors: Ramón Fernández
authors: RF
authors: de Bobadilla
authors: Joan Albert
authors: JA
authors: Arnaiz
authors: Miquel
authors: M
authors: Bioque
authors: Miquel
authors: M
authors: Bernardo
authors: Amalia
authors: A
authors: Lafuente
mesh_terms: D000293:Adolescent; D000328:Adult; D014150:Antipsychotic Agents / Q000008:administration & dosage* / Q000493:pharmacokinetics; D001480:Basal Ganglia Diseases / Q000139:chemically induced / Q000235:genetics / Q000473:pathology*; D003577:Cytochrome P-450 Enzyme System / Q000235:genetics*; D005838:Genotype; D064368:Healthy Volunteers; D006801:Humans; D010597:Pharmacogenetics / Q000379:methods; D011110:Polymorphism, Genetic; D018967:Risperidone / Q000008:administration & dosage* / Q000493:pharmacokinetics
chemical_list: D014150:Antipsychotic Agents; D003577:Cytochrome P-450 Enzyme System; C509164:CYP2D7 protein, human; D018967:Risperidone