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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 17 October 2016
Main ID:  NCT02001649
Date of registration: 14/11/2013
Prospective Registration: Yes
Primary sponsor: University Hospital, Rouen
Public title: Genetic Variants Associated With Adolescent Suicide Attempts VGTSA
Scientific title: Genetic Variants Associated With Adolescent Suicide Attempts: a Candidate-gene Association Study.
Date of first enrolment: December 2013
Target sample size: 250
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02001649
Study type:  Interventional
Study design:  Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening  
Phase:  N/A
Countries of recruitment
France
Contacts
Name:     BOJAN MIRKOVIC, MD
Address: 
Telephone:
Email:
Affiliation:  CHU Rouen, Fédération de pédopsychiatrie du Pr Gérardin
Key inclusion & exclusion criteria

Inclusion Criteria:

Case :

- Age at admission between 13 and 17 years old

- Hospitalized for attempted suicide

- Absence of prominent mental retardation or organic brain damage

- Fluent in French

- Able to comprehend the study procedures and to undergo entry assessments safely

- Provided written informed consent for study participation, and additional consent
from the patient's parents or guardians

- Northern and Western European ancestry (HapMap-CEU)

- Medical insurance coverage

Control :

- Healthy adult volunteers

- No present or past psychiatric illness

- No personal history of suicidal behavior and without a family history of suicide

- Provided written informed consent for study participation

- Northern or Western European ancestry (HapMap-CEU)

- Medical insurance coverage

Exclusion Criteria:

Case:

- Inability to get an informed and valid consent

- Home address outside the selected hospitals' geographic areas

- Intellectual disability or organic brain damage

- Origine ethnique non CEU

- Absence of medical insurance coverage

- Pregnant or lactating women

- Without Northern or Western European ancestry (HapMap-CEU)

Control :

- Inability to get an informed and valid consent

- Intellectual disability or organic brain damage

- History of suicidal behavior

- Psychiatric disorder, past or present

- Family history of suicide

- Borderline personality disorder

- Absence of medical insurance coverage

- Pregnant or lactating women

- Without Northern or Western European ancestry (HapMap-CEU)



Age minimum: 13 Years
Age maximum: 17 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Attempt Suicide
Intervention(s)
Genetic: SNP Genotyping
Primary Outcome(s)
Odds ratio (OR) and 95% confidence interval (CI) will be estimated using a logistic regression model to assessing the contribution of each polymorphism as a risk factor in predicting suicidal behavior [Time Frame: Between day 1 and day 5 during hospitalization]
Secondary Outcome(s)
Secondary ID(s)
2013/092/HP
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Institut National de la Santé Et de la Recherche Médicale, France
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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