Xploring Venlafaxine Pharmacokinetic Variability by a Phenotyping Approach (MARVEL)

NCT02590185 NA UNKNOWN

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

Details

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Phase	NA
Status	UNKNOWN
Enrolment	205
Start date	2015-12
Completion	2020-04

Conditions

• Major Depressive Disorders

Interventions

• cocktail probe drugs

Primary outcomes

• The CYP2C19 activity — 2 hours
  5-hydroxyomeprazole/omeprazole
• The CYP2D6 activity — 2 hours
  dextrorphan/dextromethorphan ratio
• The CYP3A4 activity — 2 hours
  1-hydroxymidazolam/ midazolam ratio
• The P-gp activity — 2, 3 and 6 hours
  Fexofenadine AUC based on fexofenadine concentrations

Countries

France