Typical Versus Atypical Antipsychotics; Occupation of Striatal Receptors and the Appearance of Extrapyramidal Symptomatology, in Healthy Volunteers

Summary

The purpose of this study is to determine in healthy volunteers treated with typical or atypical antipsychotics -AP-, the relationship between genetic polymorphisms in cytochrome genes CYP2D6 (\*3, \*4, \*5, \*6 and Nxn) and CYP3A5 (\*3) with antipsychotic pharmacokinetics, occupancy of striatal dopaminergic receptors and the appearance of extrapyramidal symptomatology -EPS-.

Conditions

• Pharmacogenetics
• Healthy

Interventions

DRUG

Risperidone

1 single dose of 2.5mg masked in 250 mL of peach juice, for 1 day. Oral administration.

DRUG

Placebo

1 single dose of 2.5mL physiological serum masked in 250 mL of peach juice, for 1 day. Oral administration.

DRUG

Haloperidol

1 single dose of 5mg masked in 250 mL of peach juice, for 1 day. Oral administration.

Sponsors & Collaborators

• Fundacion Clinic per a la Recerca Biomédica

  collaborator OTHER

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

  collaborator OTHER

• University of Barcelona

  collaborator OTHER

• Hospital Clinic of Barcelona

  lead OTHER

Principal Investigators

• Miquel Bernardo Arroyo, Head of Psychiatry · Hospital Clinic of Barcelona

• Amalia Lafuente Flo, Pharmacology professor · Dept. Pathologic Anatomy, Pharmacology and Microbiology, Medical Service, UB University of Barcelona

• Sergi Mas Herrero, Pos-doc assistant professor · Dept. Pathologic Anatomy, Pharmacology and Microbiology, Medical Service, UB University of Barcelona

• Patricia Gassó Astorga, Pos-doc associated professor · Dept. Pathologic Anatomy, Pharmacology and Microbiology, Medical Service, UB University of Barcelona

• Gemma Trias Lafuente, Psychologist · Dept. Pathologic Anatomy, Pharmacology and Microbiology, Medical Service, UB University of Barcelona

• Eva Ferrando Martorell, Pre-doc · Dept. Pathologic Anatomy, Pharmacology and Microbiology, Medical Service, UB University of Barcelona

• Rosa M Antonijoan, Clinical Pharmacologist · Clinical Pharmacology Service, Hospital de la Santa Creu i Sant Pau

• Analía Azaro, Clinical Pharmacologist · Clinical Pharmacology Service, Hospital de la Santa Creu i Sant Pau

• Ignasi Carrió Gasset, Head of Nuclear Med Service · Nuclear Medicine Service, Hospital de la Santa Creu i Sant Pau

• Manuel Barbanoj J Rodríguez, Head of Clinical Pharmacology, Head of Clinical Pharmacology · Clinical Pharmacology service, Hospital de la Santa Creu i Sant Pau

Study Design

Allocation

RANDOMIZED

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

30 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2011-02-28

Primary Completion

2011-11-30

Completion

2011-12-31

Countries

• Spain

Study Locations