Response to Social Rejection in Suicidal Behavior

Unipolar Depression Clinical Trial

— SADS-CS  

Official title:

Response to Social Rejection in Suicidal Behavior

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02710279
• Other study ID #: 9615
• Secondary ID: 2015-A01308-41
• Status: Terminated
• Phase: N/A
• Start date: February 19, 2016
• Est. completion date: February 15, 2018

Study information

• Verified date: December 2021
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 79
• Est. completion date: February 15, 2018
• Est. primary completion date: February 15, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Depressive Disorder
• Unipolar Depression

Intervention

Behavioral:
• Trier Social Stress Test (TSST)
For the TSST the participants are instructed to imagine having applied for their "dream job" and that they are now invited to a job interview. Three successive phases: (1) A preparation period (3 min), (2) a free speech: explain why you are the best candidate for the job (5 min), (3) a mental arithmetic complex task (5 min). The two tasks (task 2 and 3) are performed in front of a selection committee, three persons dressed in white lab coats, acting in a reserved manner and providing no facial or verbal feedback. Additionally, participants are told that they are video-taped and told that their performance will be evaluated. (in fact, there is no video-tape, just a false camera). After the TSST, patients have to answer to a questionnaire on their smartphone, 5 times a day during 7 days.

Device:
• smartphone

Locations

Country	Name	City	State
France	University Hospital of Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psychological pain response to Trier Social Stress Test (TSST) assessed by visual analogic sale	comparaison of psychological pain response between group with personal history of suicid attempt and group without personal history of suicid attempt	up to one week
Secondary	Inflammatory response to TTST	comparaison of blood markers of inflammation between groups	up to one week
Secondary	Impact of loneliness and childhood abuse on inflammatory markers	comparaison of sacles scores (ESUL : loneliness scale and CTQ : childhood abuse scale) between groups on inflammatory markers	up to one week
Secondary	impact of neuropschychological function on psychological pain	comparaison of neuropsychological tests between groups on psychological pain assessed by visual analogic scale	up to one week
Secondary	Social rejection assessed by likert scale in real life condition with a smartphone	comparaison between groups whether inflammatory / psychological pain reactivity to a single experimental episode of social rejection in the laboratory relates to real-world social experience. It consists on self-assessments (with a smartphone) by Likert scales (feelings of social disconnection or rejection during their most recent social interaction, mood, negative affects, suicidal ideation, psychological pain), 5 times per day during 7 days	7 days after the TSST