- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01493323
Functional Imaging of Psychic Pain
December 3, 2014 updated by: University Hospital, Montpellier
Neuro Anatomic Basis of Psychic Pain in Depression and Suicidal Behaviour
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.
Study Overview
Status
Terminated
Conditions
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
Enrollment (Actual)
123
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Montpellier, France, 34000
- MontpellierUniversity Hopital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Control
|
blood sample
suicide behaviour , psychic pain, social exclusion, decision making...
Other Names:
suicide behaviour , psychic pain, social exclusion, decision making...
Other Names:
suicide behaviour , psychic pain, social exclusion, decision making...
Other Names:
functional neuroimaging
Other Names:
functional neuroimaging
functional neuroimaging
Other Names:
|
|
Experimental: Depressive attempters
|
blood sample
suicide behaviour , psychic pain, social exclusion, decision making...
Other Names:
suicide behaviour , psychic pain, social exclusion, decision making...
Other Names:
suicide behaviour , psychic pain, social exclusion, decision making...
Other Names:
functional neuroimaging
Other Names:
functional neuroimaging
functional neuroimaging
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
One day
|
|
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
|
One day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Philippe PC Courtet, Professor(MD-PhD), University Hospital, Montpellier
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2010
Primary Completion (Actual)
August 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
November 10, 2011
First Submitted That Met QC Criteria
December 13, 2011
First Posted (Estimate)
December 15, 2011
Study Record Updates
Last Update Posted (Estimate)
December 4, 2014
Last Update Submitted That Met QC Criteria
December 3, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UF 8555
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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