## Protocol Section
### Identification Module
**NCT ID:** NCT02710279

**Acronym:** SADS-CS

**Brief Title:** Response to Social Rejection in Suicidal Behavior

**Official Title:** Response to Social Rejection in Suicidal Behavior

#### Organization Study ID Info
**ID:** 9615
#### Organization
**Class:** OTHER
**Full Name:** University Hospital, Montpellier
#### Secondary ID Infos
**Domain:** Agence Nationale de Sécurité des Médicaments
**ID:** 2015-A01308-41
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2018-02-15

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-08-03

**Type:** ACTUAL

**Last Update Submit Date:** 2022-08-02

**Overall Status:** TERMINATED

#### Primary Completion Date
**Date:** 2018-02-15

**Type:** ACTUAL

#### Start Date
**Date:** 2016-02-19

**Type:** ACTUAL

**Status Verified Date:** 2021-12

#### Study First Post Date
**Date:** 2016-03-16
**Type:** ESTIMATED
**Study First Submit Date:** 2016-03-11
**Study First Submit QC Date:** 2016-03-15
**Why Stopped:** difficulties in recruitment
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University Hospital, Montpellier

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Unipolar Depression

**Keywords:**

- Psychiatry

- Depressive disorder

- Suicide

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 79

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Depressive patients with or without story of suicidal behavior will pass the TSST and will have a psychological assessment to complete with a questionnaire on their smartphone

**Intervention Names:**

- Behavioral: Trier Social Stress Test (TSST)

- Device: smartphone

**Label:** Depressive patients

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Depressive patients

**Description:** 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.

**Name:** Trier Social Stress Test (TSST)

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Depressive patients

**Name:** smartphone

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** comparaison of psychological pain response between group with personal history of suicid attempt and group without personal history of suicid attempt

**Measure:** Psychological pain response to Trier Social Stress Test (TSST) assessed by visual analogic sale

**Time Frame:** up to one week

#### Secondary Outcomes

**Description:** comparaison of blood markers of inflammation between groups

**Measure:** Inflammatory response to TTST

**Time Frame:** up to one week

**Description:** comparaison of sacles scores (ESUL : loneliness scale and CTQ : childhood abuse scale) between groups on inflammatory markers

**Measure:** Impact of loneliness and childhood abuse on inflammatory markers

**Time Frame:** up to one week

**Description:** comparaison of neuropsychological tests between groups on psychological pain assessed by visual analogic scale

**Measure:** impact of neuropschychological function on psychological pain

**Time Frame:** up to one week

**Description:** 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

**Measure:** Social rejection assessed by likert scale in real life condition with a smartphone

**Time Frame:** 7 days after the TSST

### Eligibility Module

**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)

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Montpellier

**Country:** France

**Facility:** University Hospital of Montpellier

**Zip:** 34295

#### Overall Officials

**Official 1:**

**Affiliation:** University Hospital, Montpellier

**Name:** Philippe Courtet, MD PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000019964

- Term: Mood Disorders

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M7058

- Name: Depression

- Relevance: LOW

- As Found: Unknown

- ID: M7061

- Name: Depressive Disorder

- Relevance: HIGH

- As Found: Unipolar Depression

- ID: M16191

- Name: Suicide

- Relevance: LOW

- As Found: Unknown

- ID: M21835

- Name: Mood Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003866

- Term: Depressive Disorder

### Misc Info Module

- Version Holder: 2024-05-24
