Effect of Genetic Alterations Affecting the Genes Encoding the Major Enzymes of the Kynurenine Pathway on Suicidal Behavior (SuiKYN)

February 11, 2025 updated by: Centre Hospitalier Universitaire de Nīmes

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
849

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
    • Gard
      • Nîmes, Gard, France, 30029
        • Department of Psychiatry, Nimes University Hospital
  • Spain
      • Madrid, Spain, 28049
        • José-Fernandez-Piqueras

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Any patient who has expressed opposition to the use of his/her data.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
: Suicide attempters
325 patients who have made at least one attempt to commit suicide.
Genetic: SNP (single nucleotide polymorphism) genotyping
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.
Other Names:
  • Determination of allelic and genotypic frequencies of IDO1 rs7820268, IDO2 rs10109853, KMO rs1053230, KAT1 rs10988134 and ACMSD rs2121337 SNPs in each group
Depressed non-attempters
99 patients suffering from depression but have never attempted to commit suicide.
Genetic: SNP (single nucleotide polymorphism) genotyping
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.
Other Names:
  • Determination of allelic and genotypic frequencies of IDO1 rs7820268, IDO2 rs10109853, KMO rs1053230, KAT1 rs10988134 and ACMSD rs2121337 SNPs in each group
Healthy controls
425 healthy subjects (i.e. those who have no mental disorders and have never attempted to commit suicide)
Genetic: SNP (single nucleotide polymorphism) genotyping
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.
Other Names:
  • Determination of allelic and genotypic frequencies of IDO1 rs7820268, IDO2 rs10109853, KMO rs1053230, KAT1 rs10988134 and ACMSD rs2121337 SNPs in each group

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
24 months
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
24 months
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
24 months
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
24 months
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
24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
A. Frequency of single nucleotide polymorphism rs35059413 of Enzyme IDO1 in the Suicide group
Time Frame: 24 months
The frequency of this genetic variation will be measured as a percentage
24 months
A. Frequency of single nucleotide polymorphism rs35059413 of Enzyme IDO1 in the Emotion Control group
Time Frame: 24 months
The frequency of this genetic variation will be measured as a percentage
24 months
A. Frequency of single nucleotide polymorphism rs2929115 of Enzyme IDO2 in the Suicide group
Time Frame: 24 months
The frequency of this genetic variation will be measured as a percentage
24 months
A. Frequency of single nucleotide polymorphism rs2929115 of Enzyme IDO2 in the Emotion Control group
Time Frame: 24 months
The frequency of this genetic variation will be measured as a percentage
24 months
A. Frequency of single nucleotide polymorphism rs2929116 of Enzyme IDO2 in the Suicide group
Time Frame: 24 months
The frequency of this genetic variation will be measured as a percentage
24 months
A. Frequency of single nucleotide polymorphism rs2929116 of Enzyme IDO2 in the Emotion Control group
Time Frame: 24 months
The frequency of this genetic variation will be measured as a percentage
24 months
A. Frequency of single nucleotide polymorphism rs1053230 of KMO in the Suicide group
Time Frame: 24 months
The frequency of this genetic variation will be measured as a percentage
24 months
A. Frequency of single nucleotide polymorphism rs1053230 of KMO in the Emotion Control group
Time Frame: 24 months
The frequency of this genetic variation will be measured as a percentage
24 months
A. Frequency of single nucleotide polymorphism rs2275163 of KMO in the Suicide group
Time Frame: 24 months
The frequency of this genetic variation will be measured as a percentage
24 months
A. Frequency of single nucleotide polymorphism rs2275163 of KMO in the Emotion Control group
Time Frame: 24 months
The frequency of this genetic variation will be measured as a percentage
24 months
B. Simultaneous influence of the various single nucleotide polymorphisms on the functioning of the kynurenine pathway and suicidal behavior.
Time Frame: 24 months
The numerical value of the polygenic risk score will be used to measure this criterion.
24 months
C. Percentage frequency of single nucleotide polymorphisms among patients in the Suicide group.
Time Frame: 24 months
The frequency of single nucleotide polymorphisms, measured as a percentage, will be compared with the number of suicide attempts, the lethality, the method used and the intensity of suicidal ideation in the Suicide group. The polygenic risk score is calculated as a weighted sum of the risk alleles resulting from the study using GWAS (genome-wide association study) summary statistics data. This score is not calculated on a scale but as a relative risk compared to the unaffected population.
24 months
D. Correlation between negative life events triggering suicide attempts and the level of inflammation in the Suicide group.
Time Frame: 24 months
Inflammation will be measured according to the level of the main pro-inflammatory cytokines in the various samples : TGF-beta. The rate of anti-inflammatory cytokines IL-2 and IL-4 will also be measured in pg/ml and mg/ml
24 months
D. Correlation between negative life events triggering suicide attempts and the level of inflammation in the Affective Controls group.
Time Frame: 24 months
Inflammation will be measured according to the level of the main pro-inflammatory cytokines in the various samples : TGF-beta. The rate of anti-inflammatory cytokines IL-2 and IL-4 will also be measured in pg/ml and mg/ml
24 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Age of subjects
Time Frame: 24 months
The age will be recorded for statistical purposes
24 months
Gender of subjects
Time Frame: 24 months
The gender will be recorded for statistical purposes
24 months
Marital status of subjects
Time Frame: 24 months
The marital status will be recorded as a number and a percentage
24 months
Education level of subjects
Time Frame: 24 months
the education level will be recorded as a number and a percentage
24 months
Diagnosis
Time Frame: 24 months
The diagnosis will be recorded as a number and a percentage
24 months
Number of suicide attempts
Time Frame: 24 months
The number of suicide attempts will be recorded as a number
24 months
Age of first suicide attempt
Time Frame: 24 months
Age of first suicide attempt will be recorded as a number
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Nīmes

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Universidad Autonoma de Madrid

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 14, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 25, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NIMAO/2019-2/JLC-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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