NCT02590185

MetAbolism vaRiability of VEnLafaxine

Xploring Venlafaxine Pharmacokinetic Variability by a Phenotyping Approach

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 205 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Regarding the direct costs and the social value of depression, the decision of an antidepressant treatment prescription must be optimized as much as possible. The development of a personalized medicine in psychiatry may reduce treatment failure, intolerance or resistance, and hence burden and costs of affective disorders. There is hope that biomarkers will be found to guide treatment selection. It might be of decisive interest to be able to assess an individual's metabolism activity. We propose here to explore the relationship between the activity of drug-metabolizing enzymes (DME) and transporters- assessed by a phenotypic approach and the efficacy of antidepressants. We will focus on venlafaxine (V) that provides a reasonable second-step choice for patients with depression and is used extensively in psychiatric practice, and the metabolism of which involves several cytochromes (CYP) P450 enzymes and the transporter P-gp. Thus, the primary objective of this study is to study the correlation between the concentration of V and its metabolite ODesmethylV (V+ODV) and drug metabolism variability assessed by a phenotypic approach, in patients with major depressive disorder and MADRS ≥ 20 despite 4 weeks of V at 150mg or less

Conditions

• Major Depressive Disorders

Interventions

Type	Name	Description
DRUG	cocktail probe drugs	For the assessment of drug-metabolizing enzyme activity, the patients will be given the cocktail probe drugs, by oral route, one time during the study: * A capsule of omeprazole ABBOTT® 10mg * 10 mg of an oral liquid formulation of Dextrométhorphane bromhydrate (Drill Pierre FABRE MEDICAMENT® 5mg/5mL, syrup) * 1 mg of an injectable solution of Midazolam for oral administration (Midazolam Panpharma® 1mg/mL, injectable solution) * A tablet of fexofenadine Zentiva® 120mg

Timeline

• Start date: 2015-12-01
• Primary completion: 2019-12-01
• Completion: 2020-04-01
• First posted: 2015-10-28
• Last updated: 2019-02-19

Locations

2 sites across 1 country: France