Tryptophan Metabolism AlterationsSuiKYNNCT04565834
Effect of Genetic Alterations Affecting the Genes Encoding the Major Enzymes of the Kynurenine Pathway on Suicidal Behavior
An observational study of Tryptophan Metabolism Alterations and Polymorphism, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in 2 countries.
Trial summary
Current research has shown that an imbalance in the Kynurenine pathway plays a role in the physiopathology of neurogenerative and mental disorders (with a decrease in neuroprotective metabolites and an increase in neurotoxic products). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tryptophan Metabolism Alterations, Polymorphism, Suicidal Behavior
- What is being tested?
- SNP (single nucleotide polymorphism) genotyping
- How many people
- 849 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Dec 2019to 1 Mar 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients for whom biological samples have been collected and registered in the hospital's databank for the purpose of previously registered studies : SPAD (RCB no. 2016-A01375-46), SMART-CRISIS (RCB no.: 2017-A02634-49) and SUI-PREDICT (RCB no.: 2016-A00845-46) and several studies conducted at the university hospitals of Puerta de Hierro, Ramon y Cajal et Fundacion Jiminez Diaz in Madrid, Spain, since 2004.
Who may be able to join
- For the "Sucide attempters" group: Any patient aged 18 or over who has made at least one suicide attempt.
- For the two control groups: Any patient aged 18 or over, suffering from depression but has never attempted to commit suicide and any healthy subject who has never had any mental disorders.
Who cannot join
- Any patient who has expressed opposition to the use of his/her data.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
France1 site
Department of Psychiatry, Nimes University Hospital
Nîmes, Gard, 30029
About this study
Official title: Étude Des Altérations Génétiques (polymorphismes) Des Gènes-clés De La Voie Kynurénine Sur Le Comportement Suicidaire
Current research has shown that an imbalance in the Kynurenine pathway plays a role in the physiopathology of neurogenerative and mental disorders (with a decrease in neuroprotective metabolites and an increase in neurotoxic products). So far the research has concentrated on the enzymes IDO 1/2, KAT (1-4), KMO and ACMSD which are the key players in this pathway. Several polymorphisms affecting these enzymes have been associated with certain disorders characterized by a deregulation of the inflammation and immune response (McCauley et al 2009,Tardito et al 2013, Lee et al 2014), but the link between these enzymes and suicidal behavior is not yet clear. The investigators hypothesize that people with history of suicide attempt would have a genetic alterations of the kynurenine pathway specific for suicidal behavior.
- Being tested
- SNP (single nucleotide polymorphism) genotyping
- Keywords
- sucidal behavior, Inflammation, Kynurenines
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SNP (single nucleotide polymorphism) genotypingGenetic
Also called Determination of allelic and genotypic frequencies of IDO1 rs7820268, IDO2 rs10109853, KMO rs1053230, KAT1 rs10988134 and ACMSD rs2121337 SNPs in each group
We use TaqMan technique to perform SNP genotyping. The PCR reactions are carried out using the Roche "Light Cycler 480" thermal cycler following the protocol recommended by Thermo Fisher Scientific. Then, replication of 10% of the samples is carried out.
| Study group | Role | What they receive |
|---|---|---|
| : Suicide attempters | 325 patients who have made at least one attempt to commit suicide. Receives: Genetic: SNP (single nucleotide polymorphism) genotyping | |
| Depressed non-attempters | 99 patients suffering from depression but have never attempted to commit suicide. Receives: Genetic: SNP (single nucleotide polymorphism) genotyping | |
| Healthy controls | 425 healthy subjects (i.e. those who have no mental disorders and have never attempted to commit suicide) Receives: Genetic: SNP (single nucleotide polymorphism) genotyping |
What is being measured
The primary outcome is the main question the study is designed to answer.
The genotypic and allelelic frequencies of IDO1 rs7820268 SNP in each studied group
The frequencies of this SNP will be measured as a percentage
Measured: 24 months
The genotypic and allelelic frequencies of IDO2 rs10109853 SNP in each studied group
The frequencies of this SNP will be measured as a percentage
Measured: 24 months
The genotypic and allelelic frequencies of KMO rs1053230 SNP in each studied group
The frequencies of this SNP will be measured as a percentage
Measured: 24 months
The genotypic and allelelic frequencies of KAT1 rs10988134 SNP in each studied group
The frequencies of this SNP will be measured as a percentage
Measured: 24 months
The genotypic and allelelic frequencies of ACMSD rs2121337 SNP in each studied group
The frequencies of this SNP will be measured as a percentage
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start1 Dec 2019
- Primary completion1 Mar 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tryptophan Metabolism AlterationsStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 849 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Autonoma de Madrid
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04565834
- Sponsor's protocol ID
- NIMAO/2019-2/JLC-01
- Acronym
- SuiKYN
- Status last verified
- Jun 2023
- First submitted
- 14 Sep 2020
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Étude Des Altérations Génétiques (polymorphismes) Des Gènes-clés De La Voie Kynurénine Sur Le Comportement Suicidaire
- ClinicalTrials.gov ID
- NCT04565834
- Acronym / sponsor ID
- SuiKYN / NIMAO/2019-2/JLC-01
- Keywords
- sucidal behavior, Inflammation, Kynurenines
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 849 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Collaborators
- Universidad Autonoma de Madrid
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 25 Sep 2020 (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.
Current research has shown that an imbalance in the Kynurenine pathway plays a role in the physiopathology of neurogenerative and mental disorders (with a decrease in neuroprotective metabolites and an increase in neurotoxic products). So far the research has concentrated on the enzymes IDO 1/2, KAT (1-4), KMO and ACMSD which are the key players in this pathway. Several polymorphisms affecting these enzymes have been associated with certain disorders characterized by a deregulation of the inflammation and immune response (McCauley et al 2009,Tardito et al 2013, Lee et al 2014), but the link between these enzymes and suicidal behavior is not yet clear. The investigators hypothesize that people with history of suicide attempt would have a genetic alterations of the kynurenine pathway specific for suicidal behavior.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| : Suicide attempters | – | Genetic: SNP (single nucleotide polymorphism) genotyping325 patients who have made at least one attempt to commit suicide. |
| Depressed non-attempters | – | Genetic: SNP (single nucleotide polymorphism) genotyping99 patients suffering from depression but have never attempted to commit suicide. |
| Healthy controls | – | Genetic: SNP (single nucleotide polymorphism) genotyping425 healthy subjects (i.e. those who have no mental disorders and have never attempted to commit suicide) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients for whom biological samples have been collected and registered in the hospital's databank for the purpose of previously registered studies : SPAD (RCB no. 2016-A01375-46), SMART-CRISIS (RCB no.: 2017-A02634-49) and SUI-PREDICT (RCB no.: 2016-A00845-46) and several studies conducted at the university hospitals of Puerta de Hierro, Ramon y Cajal et Fundacion Jiminez Diaz in Madrid, Spain, since 2004.
Key inclusion criteria (2 listed)
- For the "Sucide attempters" group: Any patient aged 18 or over who has made at least one suicide attempt.
- For the two control groups: Any patient aged 18 or over, suffering from depression but has never attempted to commit suicide and any healthy subject who has never had any mental disorders.
Key exclusion criteria (1 listed)
- Any patient who has expressed opposition to the use of his/her data.
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 |
|---|---|---|
| SNP (single nucleotide polymorphism) genotypingAlso: Determination of allelic and genotypic frequencies of IDO1 rs7820268, IDO2 rs10109853, KMO rs1053230, KAT1 rs10988134 and ACMSD rs2121337 SNPs in each groupWe use TaqMan technique to perform SNP genotyping. The PCR reactions are carried out using the Roche "Light Cycler 480" thermal cycler following the protocol recommended by Thermo Fisher Scientific. Then, replication of 10% of the samples is carried out. | Genetic | : Suicide attempters, Depressed non-attempters, Healthy controls |
Primary outcome
The genotypic and allelelic frequencies of IDO1 rs7820268 SNP in each studied group
Time frame: 24 months
The frequencies of this SNP will be measured as a percentage
The genotypic and allelelic frequencies of IDO2 rs10109853 SNP in each studied group
Time frame: 24 months
The frequencies of this SNP will be measured as a percentage
The genotypic and allelelic frequencies of KMO rs1053230 SNP in each studied group
Time frame: 24 months
The frequencies of this SNP will be measured as a percentage
The genotypic and allelelic frequencies of KAT1 rs10988134 SNP in each studied group
Time frame: 24 months
The frequencies of this SNP will be measured as a percentage
The genotypic and allelelic frequencies of ACMSD rs2121337 SNP in each studied group
Time frame: 24 months
The frequencies of this SNP will be measured as a percentage
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
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Tryptophan Metabolism Alterations, Celiac Disease
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tryptophan Metabolism Alterations and Polymorphism, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in 2 countries.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France, Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The genotypic and allelelic frequencies of IDO1 rs7820268 SNP in each studied group (time frame: 24 months). The study lists 5 primary outcomes in all. 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 13 Feb 2025.