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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-08

Study Completion Date

2025-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Personalized Pharmacotherapy Using Pharmacogenetics in Veterans

NCT06335043

Pharmacogenetic Testing to Determine Pharmacological Treatment in PTSD

RECRUITING NA

Implementation of a Post-traumatic Stress Disorder PREvention Program Within the French ARmy

NCT05094531

Post Traumatic Stress Disorder

UNKNOWN NA

Predictors of Treatment Response to Fluoxetine in PTSD Following a Recent History of War Zone Stress Exposure

NCT00633685

Posttraumatic Stress Disorder, Combat-related

UNKNOWN PHASE4

Norepinephrine Transporter Availability in PTSD

NCT01799837

Posttraumatic Stress Disorder

COMPLETED PHASE1

Monoamine Transporters Genotypes: Risk of PTSD and Related Comorbidities

NCT00403455

PTSD

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Depression Anxiety Ptsd

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Prescription with pharmacogenetics assistance

The participants randomized in this arm will received a prescription of antidepressants based on the results of pharmacogenetics analyses.

Blood collection

Intervention Type BIOLOGICAL

A blood sample will be collected at enrollment to perform pharmacogenetics analyses.

Questionnaires

Intervention Type OTHER

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)

Intervention Type OTHER

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.

Blood collection

Intervention Type BIOLOGICAL

A blood sample will be collected at enrollment to perform pharmacogenetics analyses.

Questionnaires

Intervention Type OTHER

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)

Intervention Type OTHER

For patients participating in the ELAN ancillary study : the participants will undergo a battery of neurocognitive tests assessing motivation ("élan vital" in French).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Blood collection

A blood sample will be collected at enrollment to perform pharmacogenetics analyses.

Intervention Type BIOLOGICAL

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).

Intervention Type 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).

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No