Clinical trial NCT04987047: Evaluation of the Relevance of Pharmacogenetics in the Prescription Off Antidepressants in a Military Population
Official title: Evaluation of the Relevance of Pharmacogenetics in the Prescription Off Antidepressants in a Military Population
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Depression
Anxiety
Ptsd
Keywords: antidepressants
pharmacogenetics
Lead sponsor: Direction Centrale du Service de Santé des Armées
Sponsor class: OTHER
First posted: 2021-08-03
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of patients with a Frequency, Intensity, and Burden of Side Effects Ratings (FIBSER) scale deleterious score ≤ 2 after 8 weeks of treatment
timeFrame: 8 weeks after antidepressant treatment initiation
Secondary outcomes:
Other outcomes:
Locations:
city: Clamart
country: France
facility: Hôpital d'Instruction des Armées Percy
city: Marseille
country: France
facility: Hôpital d'Instruction des Armées Laveran
city: Saint-Mandé
country: France
facility: Hôpital d'Instruction des Armées Bégin
city: Toulon
country: France
facility: Hôpital d'Instruction des Armées Sainte-Anne
Study officials:
References: