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We propose here to explore systematically the association between drug-metabolizing enzymes activity assessed by a phenotypical approach and antidepressant plasma concentration, efficacy and tolerance in the clinical setting. During one year, patients receiving antidepressant will be included in tis prospective clinical, naturalistic and descriptive pilot study.
Full description
During the visit V0 with an investigator: patients will be included:
During the visit V1, will take place:
Phenotypic study
Genetic study
Dosage of current antidepressant drug
Clinical evaluation: efficacy and tolerance
Maximal delay of participation for the patient: 4 months even when V1 was not performed
-Overall duration of inclusion: one year Maximal overall duration of the study: 12 months+4 months= 16 months Maximal duration for the analytical study since the beginning of the study= 16 months+6 months: 22 months.
Maximal delay for communication of the results: 2 years after the beginning of the study
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Inclusion criteria
Exclusion criteria
Renal or hepatic impairment (Clearance below 60mL/min, AST or ALT over 3N) Sensitivity to any of the substrate drugs used ECG showing long QT interval (>0.46sec) No antidepressant dosage available Current pregnancy or desire to get pregnant
Criteria to perform V1 Sufficient compliance between V0 and V1 Six weeks period without change in antidepressant therapy
100 participants in 1 patient group
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Central trial contact
Celia Lloret-Linares, MD, PhD
Data sourced from clinicaltrials.gov
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