Clinical trial NCT02710279: Response to Social Rejection in Suicidal Behavior
Official title: Response to Social Rejection in Suicidal Behavior
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Unipolar Depression
Keywords: Psychiatry
Depressive disorder
Suicide
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2016-03-16
Enrollment: 79
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Suicide is a major health problem that causes annually a million death worldwild. In the stress-vulnerability model, suicidal behavior (SB) results from the interaction between an individual's predisposition and stressful condition. We hypothesized that the sensitivity to social exclusion may represent a core component of the suicidal vulnerability Recent evidence also suggest that inflammatory mediators plays a critical role in SB. Furthermore, social stressors are particulary strong and specific triggers of inflammatory response.

To sum up, patients carrying a suicidal vulnerability are expected to present greater responses to social rejection in terms of inflammatory activity and psychological pain.

The aim of the study is to evaluate the psychological and inflammatory responses to a social stressor validated, the Trier Social Stress Test (TSST) . We will also investigate the moderating effect of childhood abuse, attachment, trait rejection sensitivity and social isolation.

In the second part of the study, we will also investigate the prospective association between inflammatory responses induces by laboratory paradigms of social rejection and the occurrence of social distress, suicidal ideation and psychological pain in response to social exclusion events in real life (using ecological momentary assessment).

Detailed description: Over one year, we will recruit 140 female outpatients suffering from a major depressive episode with (n=70) and without any history of suicide attempt (n=70) from a specialized clinic for mood disorders and SB.

First visit: clinical, biological and neuropsychological assessment Second visit: The TSST is a standardized laboratory psychosocial stress protocol that involves public speaking, role play, and mental arithmetic tasks in front of a panel of confederate judges. Blood samples will be obtained before the introduction to the TSST and immediately after and at + 30, + 60, + 90, and + 120 min. Self-ratings of emotional states, anxiety, anger and psychological pain will be completed at the same times.

Third visit: Participants will be instructed to carry a smartphone with them for one week, and to record at each alarm signal daily life events, negative emotions, psychological pain, suicidal ideas, and specific attributions to these events. Participants will be signalled five times a day during the period. Subjects will be contacted by telephone halfway through the assessment period to monitor and encourage compliance.

Eligibility criteria: Inclusion Criteria:

* Non specifics
* Female
* Between 18 and 65 years
* Main diagnosis of unipolar major depressive episode (DSM-IV criteria)
* Having signed informed consent
* Able to understand nature, aims, and methodology oh the study
* Specifics :
* Having a personal history of suicidal behavior (group : depressed patient with history of SB) OR
* Not Having personal history of suicidal behavior (group : depressed patient without history of SB)

Exclusion criteria:

* Inflammatory or intercurrent pathology
* Lifetime history of schizophrenia, or schizoaffective or bipolar disorder, according to DSM-IV criteria;
* Current diagnosis of substance abuse or dependence in the last year (excluding tobacco)
* Current organic mental disorder or mental retardation, or severe comorbid medical condition
* Participation in another clinical trial
* Pregnancy
* Not able to speak, read and understand French
* Patient on protective measures (guardianship or trusteeship)

Primary outcomes:
measure: Psychological pain response to Trier Social Stress Test (TSST) assessed by visual analogic sale
timeFrame: up to one week
Secondary outcomes:
measure: Inflammatory response to TTST
timeFrame: up to one week
measure: Impact of loneliness and childhood abuse on inflammatory markers
timeFrame: up to one week
measure: impact of neuropschychological function on psychological pain
timeFrame: up to one week
measure: Social rejection assessed by likert scale in real life condition with a smartphone
timeFrame: 7 days after the TSST
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University Hospital of Montpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Philippe Courtet, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: