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

Depression Clinical Trial

— PSYGEN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04987047
• Other study ID #: 2021RC01
• Secondary ID: 2021-A00809-32
• Status: Recruiting
• Start date: November 8, 2021
• Est. completion date: November 2025

Study information

• Verified date: April 2023
• Source: Direction Centrale du Service de Santé des Armées
• Contact: Emeric SAGUIN, MD
• Phone: 143985440
• Email: emeric.saguin[@]intradef.gouv.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: November 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Depression
• Ptsd

Intervention

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).
• 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).

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
Direction Centrale du Service de Santé des Armées

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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