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Functional Imaging of Psychic Pain

Primary Purpose

Suicide, Attempted, Mood Disorder

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Assessment of personality traits
Assessment of suicidal act
Assessment of depression
Cyber ball game
Iowa Gambling Task
Microcomputer
blood sample
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Suicide, Attempted focused on measuring Psychic pain, Social exclusion, Mood disorders, Suicide, attempted, Magnetic Resonance Imaging, Functional, Genetic, Physic pain

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • MontpellierUniversity Hopital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Control

Depressive attempters

Arm Description

Outcomes

Primary Outcome Measures

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
Cerebral regions associated with perception of social exclusion
Magnetic Resonance Imaging to visualize the cerebral regions associated with perception of social exclusion

Secondary Outcome Measures

Full Information

First Posted
November 10, 2011
Last Updated
December 3, 2014
Sponsor
University Hospital, Montpellier
Collaborators
University Hospital, Geneva, Institut National de la Santé Et de la Recherche Médicale, France
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1. Study Identification

Unique Protocol Identification Number
NCT01493323
Brief Title
Functional Imaging of Psychic Pain
Official Title
Neuro Anatomic Basis of Psychic Pain in Depression and Suicidal Behaviour
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Terminated
Why Stopped
difficult to patient inclusion
Study Start Date
May 2010 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
Collaborators
University Hospital, Geneva, Institut National de la Santé Et de la Recherche Médicale, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide, Attempted, Mood Disorder
Keywords
Psychic pain, Social exclusion, Mood disorders, Suicide, attempted, Magnetic Resonance Imaging, Functional, Genetic, Physic pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
123 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Experimental
Arm Title
Depressive attempters
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Assessment of personality traits
Other Intervention Name(s)
impulsivity, anger, anxiety, emotional lability, self-administered questionnaires
Intervention Description
suicide behaviour , psychic pain, social exclusion, decision making...
Intervention Type
Behavioral
Intervention Name(s)
Assessment of suicidal act
Other Intervention Name(s)
SIS, RRRS
Intervention Description
suicide behaviour , psychic pain, social exclusion, decision making...
Intervention Type
Behavioral
Intervention Name(s)
Assessment of depression
Other Intervention Name(s)
BDI, HAMD-21
Intervention Description
suicide behaviour , psychic pain, social exclusion, decision making...
Intervention Type
Procedure
Intervention Name(s)
Cyber ball game
Other Intervention Name(s)
fIRM
Intervention Description
functional neuroimaging
Intervention Type
Procedure
Intervention Name(s)
Iowa Gambling Task
Intervention Description
functional neuroimaging
Intervention Type
Procedure
Intervention Name(s)
Microcomputer
Other Intervention Name(s)
palm
Intervention Description
functional neuroimaging
Intervention Type
Procedure
Intervention Name(s)
blood sample
Intervention Description
blood sample
Primary Outcome Measure Information:
Title
Cerebral regions associated with psychic pain during a major depressive disorder
Description
Magnetic Resonance Imaging to visualize cerebral regions associated with psychic pain during a major depressive disorder
Time Frame
One day
Title
Cerebral regions associated with perception of social exclusion
Description
Magnetic Resonance Imaging to visualize the cerebral regions associated with perception of social exclusion
Time Frame
One day

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe PC Courtet, Professor(MD-PhD)
Organizational Affiliation
University Hospital, Montpellier
Official's Role
Principal Investigator
Facility Information:
Facility Name
MontpellierUniversity Hopital
City
Montpellier
ZIP/Postal Code
34000
Country
France

12. IPD Sharing Statement

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Functional Imaging of Psychic Pain

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