CompletedNot Applicable

Genetics of Self-injurious Behaviour

234 participantsStarted 2014-05-09

Plain-language summary

Nonsuicidal Self-Injury (NSSI) is being increasingly regarded as a separate psychiatric disorder. Since the latest Diagnostic and Statistical Manual of Mental Disorders - DSM-5 from 2013 defined NSSI as a separate diagnosis under section III - Conditions for Further Study, the knowledge about this field has increased considerably; however, the aetiology of this behaviour has still not been explained. There are many psychological explanations for the development and the continuation of NSSI. Researchers have identified the most common comorbidities (depression, borderline personality disorder, anxiety). The causes of NSSI are not known, although studies that have been carried out so far indicate both genetic and environmental factors. The research included 95 adolescents with NSSI (participants were diagnosed based on the DSM-5 criteria), an original control group consisting of 21 people without NSSI, and 118 individuals from the general population as an additional control group for genetic research. For all participants we carried out the genotyping of polymorphisms for the TPH1 (rs4537731, rs1799913, rs7933505), SLC6A4 (VNTR STin2), OPRM1 (rs1799971), GNβ3 (rs5443) and DRD2/ANKK1 (rs1800497) genes. The participants with NSSI and the control group without NSSI completed translated questionnaires for the Barratt Impulsiveness Scale (BIS-11), State-Trait Anxiety Inventory for Adults (STAI), MacLean Screening Instrument for BPD (MSI-BPD) and the Early Trauma Inventory Self Report-Short Form (ETISR-SF). The participants with NSSI also completed the questionnaire for the Inventory of Statements about Self-Injury (ISAS), and the Self-Injury Craving Questionnaire (SICQ). The investigators carried out an association analysis and G x E analyses. The aim of the research was to carry out the first G x E study on the etiology of NSSI in Slovene adolescents. We have hypothesized that NSSI could be associated with one of the candidate polymorphisms or a combination of candidate polymorphisms. Further we have hypothesized that the genetic polymorphisms associated to NSSI are the most connected to NSSI in traumatised individuals and that NSSI is associated with higher impulsivity.

Who can participate

Age range

12 Years – 24 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Clinical sample Inclusion Criteria All of the adolescents from the clinical sample met the research criteria for NSSI proposed in section III (Conditions for further study) of the DSM-5 (American Psychiatric Association, 2013): (A)In the last year, the individual has, on 5 or more days, engaged in intentional self-inflicted damage to the surface of his or her body of a sort likely to induce bleeding, bruising, or pain (e.g., cutting, burning, stabbing, hitting, and excessive rubbing), with the expectation that the injury will lead to only minor or moderate physical harm (i.e., there is no suicidal intent). Note: The absence of suicidal intent has either been stated by the individual or can be inferred by the individual's repeated engagement in a behavior that the individual knows, or has learned, is not likely to result in death. (B)The individual engages in the self-injurious behavior with one or more of the following expectations:(1)to obtain relief from a negative feeling or cognitive state,(2)to resolve an interpersonal difficulty,(3)to induce a positive feeling state. Note: The desired relief or response is experienced during or shortly after the self-injury, and the individual may display patterns of behavior suggesting a dependence on repeatedly engaging in it. (C)The intentional self-injury is associated with at least one of the following:(1)interpersonal difficulties or negative feelings or thoughts, such as depression, anxiety, tension, anger, generalized distr…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Two generalized linear models between the polymorphism rs1799971 of the OPRM1 gene, two types of anxiety as covariates and craving for NSSI as dependent variable.

Timeframe: All of the included parameters are a one time measure.

A logistic regression with the overall Early Trauma Inventory Self Report-Short Form (ETISR-SF) score, as well as SLC6A4 VNTR status as independent variables and the presence of NSSI as a dependent variable.

Timeframe: All of the included parameters are a one time measure.

Measurement of the craving for NSSI (with the Self-Injury Craving Questionnaire score) for the participants in the clinical sample.

Timeframe: All of the included parameters are a one time measure.

A logistic regression with the overall Early Trauma Inventory Self Report-Short Form (ETISR-SF) score, as well as rs1800497 polymorphism status as independent variables and the presence of NSSI as a dependent variable.

Timeframe: All of the included parameters are a one time measure.

Analysis of the relationship between candidate genotypes and pain perception during NSSI.

Timeframe: All of the included parameters are a one time measure.

Trial details

NCT IDNCT05563324

SponsorUniversity Medical Centre Maribor

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2018-06-18

View on ClinicalTrials.gov More Self Injurious Behavior Without Suicidal Intent trials

Plain-language summary

Who can participate

Age range

12 Years – 24 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Two generalized linear models between the polymorphism rs1799971 of the OPRM1 gene, two types of anxiety as covariates and craving for NSSI as dependent variable.

Timeframe: All of the included parameters are a one time measure.

Measurement of the craving for NSSI (with the Self-Injury Craving Questionnaire score) for the participants in the clinical sample.

Timeframe: All of the included parameters are a one time measure.

Analysis of the relationship between candidate genotypes and pain perception during NSSI.

Timeframe: All of the included parameters are a one time measure.