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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-A00809-32 | Other Identifier | IDRCB |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prescription with pharmacogenetics assistance | The participants randomized in this arm will received a prescription of antidepressants based on the results of pharmacogenetics analyses. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood collection | Biological | A blood sample will be collected at enrollment to perform pharmacogenetics analyses. |
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| 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will be composed of military patients consulting as outpatients or hospitalized in a psychiatric service, requiring a prescription for an antidepressant.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emeric SAGUIN, MD | Contact | 143985440 | +33 | emeric.saguin@intradef.gouv.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital d'Instruction des Armées Percy | Recruiting | Clamart | 92141 | France |
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Blood sample
| Questionnaires | 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). |
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| Cognitive test battery (optional) | Other | For patients participating in the ELAN ancillary study : the participants will undergo a battery of neurocognitive tests assessing motivation ("élan vital" in French). |
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| Hôpital d'Instruction des Armées Laveran | Not yet recruiting | Marseille | 13384 | France |
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| Hôpital d'Instruction des Armées Bégin | Recruiting | Saint-Mandé | 94160 | France |
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| Hôpital d'Instruction des Armées Sainte-Anne | Not yet recruiting | Toulon | 83000 | France |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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