Response to Social Rejection in Suicidal Behavior (NCT02710279) | Clinical Trial Compass
TerminatedNot Applicable
Response to Social Rejection in Suicidal Behavior
Stopped: difficulties in recruitment
France79 participantsStarted 2016-02-19
Plain-language 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).
Who can participate
Age range
18 Years – 65 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Psychological pain response to Trier Social Stress Test (TSST) assessed by visual analogic sale