MedDataX Logo

Functional Imaging of Psychic Pain

NCT ID: NCT01493323

Last Updated: 2014-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

123 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2014-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Suicide, Attempted Mood Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control

Group Type EXPERIMENTAL

Assessment of personality traits

Intervention Type BEHAVIORAL

suicide behaviour , psychic pain, social exclusion, decision making...

Assessment of suicidal act

Intervention Type BEHAVIORAL

suicide behaviour , psychic pain, social exclusion, decision making...

Assessment of depression

Intervention Type BEHAVIORAL

suicide behaviour , psychic pain, social exclusion, decision making...

Cyber ball game

Intervention Type PROCEDURE

functional neuroimaging

Iowa Gambling Task

Intervention Type PROCEDURE

functional neuroimaging

Microcomputer

Intervention Type PROCEDURE

functional neuroimaging

blood sample

Intervention Type PROCEDURE

blood sample

Depressive attempters

Group Type EXPERIMENTAL

Assessment of personality traits

Intervention Type BEHAVIORAL

suicide behaviour , psychic pain, social exclusion, decision making...

Assessment of suicidal act

Intervention Type BEHAVIORAL

suicide behaviour , psychic pain, social exclusion, decision making...

Assessment of depression

Intervention Type BEHAVIORAL

suicide behaviour , psychic pain, social exclusion, decision making...

Cyber ball game

Intervention Type PROCEDURE

functional neuroimaging

Iowa Gambling Task

Intervention Type PROCEDURE

functional neuroimaging

Microcomputer

Intervention Type PROCEDURE

functional neuroimaging

blood sample

Intervention Type PROCEDURE

blood sample

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Assessment of personality traits

suicide behaviour , psychic pain, social exclusion, decision making...

Intervention Type BEHAVIORAL

Assessment of suicidal act

suicide behaviour , psychic pain, social exclusion, decision making...

Intervention Type BEHAVIORAL

Assessment of depression

suicide behaviour , psychic pain, social exclusion, decision making...

Intervention Type BEHAVIORAL

Cyber ball game

functional neuroimaging

Intervention Type PROCEDURE

Iowa Gambling Task

functional neuroimaging

Intervention Type PROCEDURE

Microcomputer

functional neuroimaging

Intervention Type PROCEDURE

blood sample

blood sample

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

impulsivity anger anxiety emotional lability self-administered questionnaires SIS RRRS BDI HAMD-21 fIRM palm

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Geneva

OTHER

Sponsor Role collaborator

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role collaborator

University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Philippe PC Courtet, Professor(MD-PhD)

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

MontpellierUniversity Hopital

Montpellier, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UF 8555

Identifier Type: -

Identifier Source: org_study_id