Functional Imaging of Psychic Pain

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University Hospital, Montpellier
Sponsor:
Collaborators:
University Hospital, Geneva
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT01493323
First received: November 10, 2011
Last updated: June 17, 2014
Last verified: June 2014
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Neuro Anatomic Basis of Psychic Pain in Depression and Suicidal Behaviour

Resource links provided by NLM:


Further study details as provided by University Hospital, Montpellier:

Primary Outcome Measures:
  • Cerebral regions associated with psychic pain during a major depressive disorder [ Time Frame: One day ] [ Designated as safety issue: No ]
    Magnetic Resonance Imaging to visualize cerebral regions associated with psychic pain during a major depressive disorder

  • Cerebral regions associated with perception of social exclusion [ Time Frame: One day ] [ Designated as safety issue: No ]
    Magnetic Resonance Imaging to visualize the cerebral regions associated with perception of social exclusion


Estimated Enrollment: 150
Study Start Date: May 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Iowa Gambling Task
Procedure: Microcomputer
functional neuroimaging
Other Name: palm
Procedure: blood sample
blood sample
Other Name: 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
Other Name: Iowa Gambling Task
Procedure: Microcomputer
functional neuroimaging
Other Name: palm
Procedure: blood sample
blood sample
Other Name: blood sample

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01493323

Contacts
Contact: Philippe PC Courtet, Professor (MD-PhD) +33467338581 p-courtet@chu-montpellier.fr

Locations
France
MontpellierUniversity Hopital Recruiting
Montpellier, France, 34000
Contact: Philippe PC Courtet, Professor(MD-PhD)    +33467338581    p-courtet@chu-montpellier.fr   
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
  More Information

No publications provided

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT01493323     History of Changes
Other Study ID Numbers: UF 8555
Study First Received: November 10, 2011
Last Updated: June 17, 2014
Health Authority: France: Committee for the Protection of Personnes

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
Suicide, Attempted
Mood Disorders
Self-Injurious Behavior
Behavioral Symptoms
Mental Disorders

ClinicalTrials.gov processed this record on August 26, 2014