Evaluation of the Relevance of Pharmacogenetics in the Prescription Off Antidepressants in a Military Population
PSYGEN
2 other identifiers
observational
250
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2021
Longer than P75 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 27, 2021
CompletedFirst Posted
Study publicly available on registry
August 3, 2021
CompletedStudy Start
First participant enrolled
November 8, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2025
CompletedApril 28, 2023
April 1, 2023
3.2 years
July 27, 2021
April 27, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of patients with a Frequency, Intensity, and Burden of Side Effects Ratings (FIBSER) scale deleterious score ≤ 2 after 8 weeks of treatment
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
Study Arms (2)
Prescription with pharmacogenetics assistance
The participants randomized in this arm will received a prescription of antidepressants based on the results of pharmacogenetics analyses.
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.
Interventions
A blood sample will be collected at enrollment to perform pharmacogenetics analyses.
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).
For patients participating in the ELAN ancillary study : the participants will undergo a battery of neurocognitive tests assessing motivation ("élan vital" in French).
Eligibility Criteria
The study population will be composed of military patients consulting as outpatients or hospitalized in a psychiatric service, requiring a prescription for an antidepressant.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Hôpital d'Instruction des Armées Percy
Clamart, 92141, France
Hôpital d'Instruction des Armées Laveran
Marseille, 13384, France
Hôpital d'Instruction des Armées Bégin
Saint-Mandé, 94160, France
Hôpital d'Instruction des Armées Sainte-Anne
Toulon, 83000, France
Biospecimen
Blood sample
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 27, 2021
First Posted
August 3, 2021
Study Start
November 8, 2021
Primary Completion
February 1, 2025
Study Completion
November 1, 2025
Last Updated
April 28, 2023
Record last verified: 2023-04