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

April 27, 2023 updated by: Direction Centrale du Service de Santé des Armées

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clamart, France, 92141
        • Recruiting
        • Hôpital d'Instruction des Armées Percy
      • Marseille, France, 13384
        • Not yet recruiting
        • Hôpital d'Instruction des Armées Laveran
      • Saint-Mandé, France, 94160
        • Recruiting
        • Hopital d'Instruction des Armees BEGIN
      • Toulon, France, 83000
        • Not yet recruiting
        • Hôpital d'Instruction des Armées Sainte-Anne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population will be composed of military patients consulting as outpatients or hospitalized in a psychiatric service, requiring a prescription for an antidepressant.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Prescription with pharmacogenetics assistance
The participants randomized in this arm will received a prescription of antidepressants based on the results of pharmacogenetics analyses.
Biological: Blood collection
A blood sample will be collected at enrollment to perform pharmacogenetics analyses.
Other: Questionnaires
Several questionnaires will be filled by the participants or by the clinicians at every study visits: Hospital anxiety depression scale (HAD), Post Traumatic Stress Disorder Checklist for DSM-5 (PCL-5), Quick inventory of depressive symptomatology - self rated (QiDS), Beck's Anxiety Inventory (BAI), World Health Organization Quality Of Life (WHOQOL-BREF), EuroQol Group questionnaire (EQ5D), Frequency, intensity, burden of side effects rating (FIBSER), Udvalg for Kliniske Undersøgelser - Side Effects Rating Scale - for Patients (UKU-SERS-PAT), Clinical Global impression (CGI), Montgomery and Asberg Depression Rating Scale (MADRS).
Other: Cognitive test battery (optional)
For patients participating in the ELAN ancillary study : the participants will undergo a battery of neurocognitive tests assessing motivation ("élan vital" in French).
Prescription without pharmacogenetics assistance
The participants randomized in this arm will received a prescription of antidepressants left to the discretion of the clinician without pharmacogenetics assistance.
Biological: Blood collection
A blood sample will be collected at enrollment to perform pharmacogenetics analyses.
Other: Questionnaires
Several questionnaires will be filled by the participants or by the clinicians at every study visits: Hospital anxiety depression scale (HAD), Post Traumatic Stress Disorder Checklist for DSM-5 (PCL-5), Quick inventory of depressive symptomatology - self rated (QiDS), Beck's Anxiety Inventory (BAI), World Health Organization Quality Of Life (WHOQOL-BREF), EuroQol Group questionnaire (EQ5D), Frequency, intensity, burden of side effects rating (FIBSER), Udvalg for Kliniske Undersøgelser - Side Effects Rating Scale - for Patients (UKU-SERS-PAT), Clinical Global impression (CGI), Montgomery and Asberg Depression Rating Scale (MADRS).
Other: Cognitive test battery (optional)
For patients participating in the ELAN ancillary study : the participants will undergo a battery of neurocognitive tests assessing motivation ("élan vital" in French).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients with a Frequency, Intensity, and Burden of Side Effects Ratings (FIBSER) scale deleterious score ≤ 2 after 8 weeks of treatment
Time Frame: 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.
8 weeks after antidepressant treatment initiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Direction Centrale du Service de Santé des Armées

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 8, 2021

Primary Completion (Anticipated)

February 1, 2025

Study Completion (Anticipated)

November 1, 2025

Study Registration Dates

First Submitted

July 27, 2021

First Submitted That Met QC Criteria

July 27, 2021

First Posted (Actual)

August 3, 2021

Study Record Updates

Last Update Posted (Actual)

April 28, 2023

Last Update Submitted That Met QC Criteria

April 27, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021RC01
  • 2021-A00809-32 (Other Identifier: IDRCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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