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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01493323
Other study ID # UF 8555
Secondary ID
Status Terminated
Phase N/A
First received November 10, 2011
Last updated December 3, 2014
Start date May 2010
Est. completion date December 2014

Study information

Verified date December 2014
Source University Hospital, Montpellier
Contact n/a
Is FDA regulated No
Health authority France: Committee for the Protection of Personnes
Study type Interventional

Clinical Trial Summary

Suicidal behaviour (SB) represents a major public health problem, costing life in more that one million people every year worldwide. Even if SB is considered as a consequence of social adversity and depression, these stress factors are often necessary but not sufficient to explain the occurrence of a suicidal act. A preliminary study suggests that an increased perception of psychic pain during a major depressive disorder increases the risk of suicide behaviour. The investigators aimed to investigate the relationship between social exclusion (a classic trigger of psychic pain) and SB and improve our knowledge about the physiopathology of this domain.


Description:

Suicide behaviour (SB) represents a major public health problem. In order to improve prevention strategies, a better understanding of the physiopathology of SB is needed. According to a "stress vulnerability" model, people who make a suicide attempt when they are subject to a stress factor (environmental stress, interpersonal difficulties, depression, tobacco, substance abuse...) are those who have a specific vulnerability. Vulnerability factors to SB may be considered in clinical terms (propensity to hopelessness, aggressive impulsivity traits), neurobiological terms (serotoninergic system disorder, especially in the ventral prefrontal cortex-vPFC) and cognitive terms (decision making, cognitive functions mediated by the vPFC and the serotoninergic system). Finally, genetic factors seem also involved in suicide vulnerability. The investigators have conducted a preliminary study which suggests that increased perception of psychic pain during a major depressive disorder increases suicidal ideation and suicidal act. Study about anatomic basis of psychic pain and its triggers represents a relevant theme to understand the suicidal process. Among the classical factors triggering psychic pain and suicidal act, events of social exclusion appears to be crucial. Finally, many data suggests the close relationship between physic and psychic pain.


Recruitment information / eligibility

Status Terminated
Enrollment 123
Est. completion date December 2014
Est. primary completion date August 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility Non specific criteria, for all the participants:

- Woman- 18-50 years old

- Non menopausal

- Right-handed

- Caucasian from western Europe (exception of Basque and Sardinian), for genetic purposes

- Subject who signed informed consent

- Able to understand the nature, the aim, and the methodology of the study and agree to cooperate during clinical and radiological evaluation

Specific criteria:For depressed suicide attempters :

- DSM IV criteria for major depressive disorder

- Personal history of suicide attempt

- No psychotropic treatment currently

For depressed affective controls :

- DSM IV criteria for major depressive disorder

- No personal history of suicide attempt

- No psychotropic treatment currently

For non depressed suicide attempters :

- Personal history of unipolar or bipolar mood disorder, according to DSM IV criteria

- Normothymic currently (HAMD<7)

- Personal history of suicide attempt

- Minimum treatment Healthy controls :

- No personal history of axis I psychiatric disorders according to the MINI and the DSM IV criteria

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
Assessment of personality traits
suicide behaviour , psychic pain, social exclusion, decision making...
Assessment of suicidal act
suicide behaviour , psychic pain, social exclusion, decision making...
Assessment of depression
suicide behaviour , psychic pain, social exclusion, decision making...
Procedure:
Cyber ball game
functional neuroimaging
Iowa Gambling Task
functional neuroimaging
Microcomputer
functional neuroimaging
blood sample
blood sample

Locations

Country Name City State
France MontpellierUniversity Hopital Montpellier

Sponsors (3)

Lead Sponsor Collaborator
University Hospital, Montpellier Institut National de la Santé Et de la Recherche Médicale, France, University Hospital, Geneva

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cerebral regions associated with psychic pain during a major depressive disorder Magnetic Resonance Imaging to visualize cerebral regions associated with psychic pain during a major depressive disorder One day No
Primary Cerebral regions associated with perception of social exclusion Magnetic Resonance Imaging to visualize the cerebral regions associated with perception of social exclusion One day No
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