DepressionPSYGENNCT04987047
Evaluation of the Relevance of Pharmacogenetics in the Prescription Off Antidepressants in a Military Population
An observational study of Depression and Anxiety, run by Direction Centrale du Service de Santé des Armées at 4 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression, Anxiety, Ptsd
- What is being tested?
- Blood collection, Questionnaires and Cognitive test battery (optional)
- How many people
- 250 participants
- Where
- 4 sitesFrance
- Study dates
- 8 Nov 2021to Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
France4 sites, 4 recruiting
- Recruiting
Hôpital d'Instruction des Armées Percy
Clamart, 92141
Marie BOUSSAUD, MD, 141466298 ext. +33, marie.boussaud@intradef.gouv.fr
- Not yet recruiting
Hôpital d'Instruction des Armées Laveran
Marseille, 13384
Frédéric PAUL, MD, 491617282 ext. +33, frederic1.paul@intradef.gouv.fr
- Recruiting
Hôpital d'Instruction des Armées Bégin
Saint-Mandé, 94160
Emeric SAGUIN, MD, 143985440 ext. +33, emeric.saguin@intradef.gouv.fr
- Not yet recruiting
Hôpital d'Instruction des Armées Sainte-Anne
Toulon, 83000
Charles GHEORGHIEV, MD, 483162159 ext. +33, charles.gheorghiev@intradef.gouv.fr
About this study
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.
- Conditions
- Depression, Anxiety, Ptsd
- Being tested
- Blood collection, Questionnaires, Cognitive test battery (optional)
- Keywords
- antidepressants, pharmacogenetics
- Medical subject headings
- Depression, Anxiety Disorders, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood collectionBiological
A blood sample will be collected at enrollment to perform pharmacogenetics analyses.
QuestionnairesOther
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)Other
For patients participating in the ELAN ancillary study : the participants will undergo a battery of neurocognitive tests assessing motivation ("élan vital" in French).
| Study group | Role | What they receive |
|---|---|---|
| Prescription with pharmacogenetics assistance | The participants randomized in this arm will received a prescription of antidepressants based on the results of pharmacogenetics analyses. Receives: Biological: Blood collection; Other: Questionnaires; Other: Cognitive test battery (optional) | |
| 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. Receives: Biological: Blood collection; Other: Questionnaires; Other: Cognitive test battery (optional) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks after antidepressant treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start8 Nov 2021
- Primary completionFeb 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Direction Centrale du Service de Santé des Armées
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04987047
- Sponsor's protocol ID
- 2021RC01
- Other IDs
- 2021-A00809-32
- Acronym
- PSYGEN
- Status last verified
- Apr 2023
- First submitted
- 27 Jul 2021
- Last updated
- 28 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Relevance of Pharmacogenetics in the Prescription Off Antidepressants in a Military Population
- ClinicalTrials.gov ID
- NCT04987047
- Acronym / sponsor ID
- PSYGEN / 2021RC01
- Conditions
- Depression, Anxiety, Ptsd
- Keywords
- antidepressants, pharmacogenetics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Direction Centrale du Service de Santé des ArméesUniversity, hospital or other
- Study start
- 8 Nov 2021 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 3 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prescription with pharmacogenetics assistance | – | Biological: Blood collection, Other: Questionnaires, Other: Cognitive test battery (optional)The participants randomized in this arm will received a prescription of antidepressants based on the results of pharmacogenetics analyses. |
| Prescription without pharmacogenetics assistance | – | Biological: Blood collection, Other: Questionnaires, Other: Cognitive test battery (optional)The participants randomized in this arm will received a prescription of antidepressants left to the discretion of the clinician without pharmacogenetics assistance. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood collectionA blood sample will be collected at enrollment to perform pharmacogenetics analyses. | Biological | Prescription with pharmacogenetics assistance, Prescription without pharmacogenetics assistance |
| QuestionnairesSeveral 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). | Other | Prescription with pharmacogenetics assistance, Prescription without pharmacogenetics assistance |
| 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). | Other | Prescription with pharmacogenetics assistance, Prescription without pharmacogenetics assistance |
Primary outcome
Proportion of patients with a Frequency, Intensity, and Burden of Side Effects Ratings (FIBSER) scale deleterious score ≤ 2 after 8 weeks of treatment
Time frame: 8 weeks after antidepressant treatment initiation
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression and Anxiety, run by Direction Centrale du Service de Santé des Armées at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emeric SAGUIN, MD (143985440 ext. +33, emeric.saguin@intradef.gouv.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with a Frequency, Intensity, and Burden of Side Effects Ratings (FIBSER) scale deleterious score ≤ 2 after 8 weeks of treatment (time frame: 8 weeks after antidepressant treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2023.