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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02590185
Other study ID # AOM14562
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 2015
Est. completion date April 2020

Study information

Verified date February 2019
Source Assistance Publique - Hôpitaux de Paris
Contact celia Lloret-Linares, MD
Email celia.lloret-linares@aphp.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Recruiting
Enrollment 205
Est. completion date April 2020
Est. primary completion date December 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Patient (Hospitalized or outpatient) with major depressive disorder and MADRS = 20 at visit of selection

- Patients non responders to V after 4 weeks of V at 150mg or less

- Decision of the psychiatrist to increase the dose of V at visit of selection

- Understanding of French language and able to give a written inform consent.

- Informed consent signed to participate to the study

- Individuals covered by social security regimen

Exclusion Criteria:

- Patients treated by more than one antidepressant

- Patients currently treated with one of the drug substrate of the cocktail

- Sensitivity or contra-indication to any of the substrate drugs used

- Current pregnancy, desire to get pregnant, or breastfeeding

- Bipolar disorder and schizophrenia

Study Design


Intervention

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

Locations

Country Name City State
France Fernand Widal hospital Paris
France Lariboisiere hospital Paris

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary The CYP2C19 activity 5-hydroxyomeprazole/omeprazole 2 hours
Primary The CYP2D6 activity dextrorphan/dextromethorphan ratio 2 hours
Primary The CYP3A4 activity 1-hydroxymidazolam/ midazolam ratio 2 hours
Primary The P-gp activity Fexofenadine AUC based on fexofenadine concentrations 2, 3 and 6 hours
Secondary Tobacco use Fagerstrom test 20, 40, 70 days
Secondary Mood disorder 20, 40, 70 days
Secondary Anxiety scale Tyrer 20, 40, 70 days
Secondary QIDS-SR16 20, 40, 70 days
Secondary Criteria for rating medication trials for antidepressant failure and level of resistance 20, 40, 70 days
Secondary MARS Score 20, 40, 70 days
Secondary PRISE-M score 20, 40, 70 days
Secondary FISBER score 20, 40, 70 days
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