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Functional Imaging of Psychic Pain

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ClinicalTrials.gov Identifier: NCT01493323
Recruitment Status : Terminated (difficult to patient inclusion)
First Posted : December 15, 2011
Last Update Posted : December 4, 2014
Sponsor:
Collaborators:
University Hospital, Geneva
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief 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.

Condition or disease Intervention/treatment Phase
Suicide, Attempted Mood Disorder Behavioral: Assessment of personality traits Behavioral: Assessment of suicidal act Behavioral: Assessment of depression Procedure: Cyber ball game Procedure: Iowa Gambling Task Procedure: Microcomputer Procedure: blood sample Not Applicable

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 123 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Neuro Anatomic Basis of Psychic Pain in Depression and Suicidal Behaviour
Study Start Date : May 2010
Actual Primary Completion Date : August 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

Arm Intervention/treatment
Experimental: Control Behavioral: Assessment of personality traits
suicide behaviour , psychic pain, social exclusion, decision making...
Other Names:
  • impulsivity
  • anger
  • anxiety
  • emotional lability
  • self-administered questionnaires

Behavioral: Assessment of suicidal act
suicide behaviour , psychic pain, social exclusion, decision making...
Other Names:
  • SIS
  • RRRS

Behavioral: Assessment of depression
suicide behaviour , psychic pain, social exclusion, decision making...
Other Names:
  • BDI
  • HAMD-21

Procedure: Cyber ball game
functional neuroimaging
Other Name: fIRM

Procedure: Iowa Gambling Task
functional neuroimaging

Procedure: Microcomputer
functional neuroimaging
Other Name: palm

Procedure: blood sample
blood sample

Experimental: Depressive attempters Behavioral: Assessment of personality traits
suicide behaviour , psychic pain, social exclusion, decision making...
Other Names:
  • impulsivity
  • anger
  • anxiety
  • emotional lability
  • self-administered questionnaires

Behavioral: Assessment of suicidal act
suicide behaviour , psychic pain, social exclusion, decision making...
Other Names:
  • SIS
  • RRRS

Behavioral: Assessment of depression
suicide behaviour , psychic pain, social exclusion, decision making...
Other Names:
  • BDI
  • HAMD-21

Procedure: Cyber ball game
functional neuroimaging
Other Name: fIRM

Procedure: Iowa Gambling Task
functional neuroimaging

Procedure: Microcomputer
functional neuroimaging
Other Name: palm

Procedure: blood sample
blood sample




Primary Outcome Measures :
  1. Cerebral regions associated with psychic pain during a major depressive disorder [ Time Frame: One day ]
    Magnetic Resonance Imaging to visualize cerebral regions associated with psychic pain during a major depressive disorder

  2. Cerebral regions associated with perception of social exclusion [ Time Frame: One day ]
    Magnetic Resonance Imaging to visualize the cerebral regions associated with perception of social exclusion



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01493323


Locations
France
MontpellierUniversity Hopital
Montpellier, France, 34000
Sponsors and Collaborators
University Hospital, Montpellier
University Hospital, Geneva
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Principal Investigator: Philippe PC Courtet, Professor(MD-PhD) University Hospital, Montpellier

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT01493323     History of Changes
Other Study ID Numbers: UF 8555
First Posted: December 15, 2011    Key Record Dates
Last Update Posted: December 4, 2014
Last Verified: December 2014

Keywords provided by University Hospital, Montpellier:
Psychic pain
Social exclusion
Mood disorders
Suicide, attempted
Magnetic Resonance Imaging, Functional
Genetic
Physic pain

Additional relevant MeSH terms:
Suicide
Mood Disorders
Suicide, Attempted
Self-Injurious Behavior
Behavioral Symptoms
Mental Disorders