Evaluation of the Relevance of Pharmacogenetics in the Prescription Off Antidepressants in a Military Population

Recruiting

• Conditions: Ptsd; Depression; Anxiety
• Interventions: Biological: Blood collection; Other: Questionnaires; Other: Cognitive test battery (optional)

• Registration Number: NCT04987047
• Lead Sponsor: Direction Centrale du Service de Santé des Armées

Brief Summary

The treatment of depression, anxiety disorders and post-traumatic stress disorder (PTSD) is a main public health problem due to the frequency of these pathologies and the very partial effectiveness of the existent therapies. These illnesses generally require the prescription of several successive lines of antidepressant treatments before the treatments actually become effective, leading to a several week delay during which the patient suffers from the symptoms of his/her pathology and is also likely to experience the side effects of the treatment.

Pharmacogenetics is an individualized prescribing modality that aims to predict the most favorable treatment for a given individual based on the study of genetic variants of cytochromes.

The main hypothesis of this research is that the use of pharmacogenetics in routine practice in a population of military personnel requiring a first prescription of an antidepressant is of interest to improve the tolerance and effectiveness of the treatment.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-27
• Study First Submitted QC: 2021-07-27
• Study First Posted: 2021-08-03
• Study Start: 2021-11-08
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-27
• Last Update Posted: 2023-04-28
• Primary Completion: 2025-02
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• Between 18 and 65 years-old;
• To benefit from a medical follow-up in the psychiatric department of an army training hospital;
• To present a pathology requiring an antidepressant treatment and whose prescription can wait 10 days;
• To have given written informed consent to participate in the study.

Exclusion Criteria

• To be currently treated with an antidepressant or antidepressant stopped less than 15 days ago;
• To have one or more contraindication to the introduction of an antidepressant treatment;
• Pregnancy or breastfeeding;
• To require a measure of constraint.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prescription without pharmacogenetics assistance	Blood collection	The participants randomized in this arm will received a prescription of antidepressants left to the discretion of the clinician without pharmacogenetics assistance.
Prescription with pharmacogenetics assistance	Questionnaires	The participants randomized in this arm will received a prescription of antidepressants based on the results of pharmacogenetics analyses.
Prescription with pharmacogenetics assistance	Blood collection	The participants randomized in this arm will received a prescription of antidepressants based on the results of pharmacogenetics analyses.
Prescription with pharmacogenetics assistance	Cognitive test battery (optional)	The participants randomized in this arm will received a prescription of antidepressants based on the results of pharmacogenetics analyses.
Prescription without pharmacogenetics assistance	Cognitive test battery (optional)	The participants randomized in this arm will received a prescription of antidepressants left to the discretion of the clinician without pharmacogenetics assistance.
Prescription without pharmacogenetics assistance	Questionnaires	The participants randomized in this arm will received a prescription of antidepressants left to the discretion of the clinician without pharmacogenetics assistance.

Primary Outcome Measures

Name	Time	Method
Proportion of patients with a Frequency, Intensity, and Burden of Side Effects Ratings (FIBSER) scale deleterious score ≤ 2 after 8 weeks of treatment	8 weeks after antidepressant treatment initiation	This endpoint will allow to assess the clinical tolerance of antidepressant treatment and to compare the results between the 2 arms.; The FIBSER scale score ranges from 0 to 18 with higher scores reflecting more deleterious side effects.

Trial Locations

Locations (4)

Hôpital d'Instruction des Armées Percy; 🇫🇷 Clamart, France

Hôpital d'Instruction des Armées Laveran; 🇫🇷 Marseille, France

Hôpital d'Instruction des Armées Bégin; 🇫🇷 Saint-Mandé, France

Hôpital d'Instruction des Armées Sainte-Anne; 🇫🇷 Toulon, France