Drug Metabolism and Antidepressant — METADEP  

Depression Clinical Trial

Official title: Cocktail Phenotypic Approach to Explore Antidepressant Pharmacokinetic Variability: a Pilot Study

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

• Objectives To describe drug metabolism variability in depressive patients using a phenotypic approach

• Study design Prospective, clinical, naturalistic, descriptive study During a consultation with their clinician, depressive patients will receive information.

During the visit V0 with an investigator: patients will be included:

• Verification of inclusion and non inclusion criteria

• Reminder participation conditions

• Inclusion, signature of consent

• Collection of clinical and demographic features Between V0 and V1, for patients with change in antidepressant therapy, will take place telephone interviews every two weeks, conducted by the clinician to evaluate treatment depression response (tolerance and efficacy)

During the visit V1, will take place:

• Phenotypic study

• Genetic study

• Dosage of current antidepressant drug

• Clinical evaluation: efficacy and tolerance

• Number of patients During one year, the protocol will be proposed to all patients with depression and decision of change in antidepressant therapy, and all patients with stability od prescription since almost 6 weeks. The inclusion of approximately 100 patients is expected.

• Name of the finished product Zyban®, Froben®, Antra®, Bexine®, Dormicum® Telfast®

• Name of the active substance Omeprazole (10 mg, A02BC01) Caffeine (50 mg, N06BC01) Flurbiprofen (10 mg, M01AE09) Dextromethorphan (10 mg, R05DA09) Midazolam (1 mg, N05CD08) Fexofenadine (25mg, R06AX26 ) Bupropion (20 mg, N06AX12)

• Duration of treatment One time during the study, one day (Visit 1)

• Time plan of research -Duration for the patient: The study will stop when the patient has performed the V1 study Minimal delay between V0 and V1: 6 weeks (5-7 weeks) : for patient with decision to change the treatment, 5 days for patients with stability of treatment since almost 6 weeks.

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 ;

Study Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Depression

• NCT number: NCT02438072
• Study type: Interventional
• Source: University Hospital, Geneva
• Contact: Celia Lloret-Linares, MD, PhD
• Phone: 0041 79 55 36 389
• Email: Celia.LloretLinares@hcuge.ch
• Status: Recruiting
• Phase: N/A
• Start date: December 2014
• Completion date: December 2015