Status:
UNKNOWN
Typical Versus Atypical Antipsychotics; Occupation of Striatal Receptors and the Appearance of Extrapyramidal Symptomatology, in Healthy Volunteers
Lead Sponsor:
Hospital Clinic of Barcelona
Collaborating Sponsors:
Fundacion Clinic per a la Recerca Biomédica
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Conditions:
Pharmacogenetics
Healthy
Eligibility:
All Genders
18-30 years
Phase:
PHASE1
Brief 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, \*...
Detailed Description
Objective: The preliminary results indicate that pharmacological factors (AP, dose and drug availability depending on cytochrome activity) are risk factors for AP-induced EPS. In this clinical trial...
Eligibility Criteria
Inclusion
- Inclusion Criteria that chosen participants must fulfill:
- Subjects of both genders with ages between 18-30 years.
- Subjects with normal values of clinical history and physical exploration.
- Subjects without evidence of significant disease, organic or psychiatric, according to anamnesis (medical history), physical exploration and complementary tests.
- Subjects with normal values of laboratory tests (hemogram and biochemical tests).
- Subjects with normal values of vital signs (Blood pressure, Heart rate, Temperature) and Electrocardiography.
- Female subjects must be using safe contraceptive methods, different from oral contraceptives.
- Subjects could not have taken part in other clinical trials during the three previous months before to the beginning of this study.
- Subjects could not have given blood during four weeks before the beginning of this study.
- Subjects must accept freely their participation, with written informed consent.
- After previous genotyping for CYP2D6 and CYP3A4/A5 genes, chosen participants must have one of the following genotypes of interest for this study:
- poor metabolizers (PM) CYP2D6\*
- poor metabolizers (PM) CYP3A5\*\*
- extensive metabolizers (EM) CYP2D6/CYP3A
- ultrarapid metabolizers (UM) CYP2D6\*
- Subjects must accept to undergo neuroimaging (SPECT).
- Exclusion Criteria to reject potential participants:
- Subjects with previous medical history of alcoholism or drug dependency.
- Subjects with clinical history of allergy, idiosyncrasy or hypersensitivity to drugs.
- Subjects with clinical history or current treatment with drugs whose metabolism could interfere in the action of CYP2D6 and CYP3A5 cytochromes, particularly if they are not able to give up the treatment for a period of 3-4 weeks before the beginning of the study and during its execution.
- Subjects with clinical history or current consumption of drugs that could interfere in the action of CYP2D6 and CYP3A5 cytochromes (St John's wort, cruciferae, grapefruit ...), particularly if they are not able to give up their consumption for a period of 3-4 weeks before the beginning of the study and during its execution.
- Subjects with contraindications for antipsychotic treatments due to: familiar/clinical history of hypersensitivity to antipsychotic drugs, deep depression of central nervous system, coma, Parkinson's disease.
- Pregnant women, women in breastfeeding period or women that do not use safe contraceptive methods, different from oral contraception.
- Subjects with positive serology for hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV).
- Subjets with positive test in urine for ethanol, cannabis, cocaine, amphetamines, benzodiazepines and/or opiates.
Exclusion
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2011
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01259973
Start Date
February 1 2011
End Date
December 1 2011
Last Update
April 18 2011
Active Locations (2)
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1
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, Spain, 08025
2
Hospital Clinic of Barcelona
Barcelona, Barcelona, Spain, 08036