## Protocol Section
### Identification Module
**NCT ID:** NCT02915679

**Acronym:** DOCS

**Brief Title:** Pain Perception in Suicidal Behavior Vulnerability

**Official Title:** Pain Perception in Suicidal Behavior Vulnerability

#### Organization Study ID Info
**ID:** UF 9185
#### Organization
**Class:** OTHER
**Full Name:** University Hospital, Montpellier
#### Secondary ID Infos
**Domain:** Agence Nationale de Sécurité des Médicaments
**ID:** 2013-A01029-36
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2021-05-06

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-01-11

**Type:** ACTUAL

**Last Update Submit Date:** 2021-12-20

**Overall Status:** TERMINATED

#### Primary Completion Date
**Date:** 2021-05-06

**Type:** ACTUAL

#### Start Date
**Date:** 2015-06-17

**Status Verified Date:** 2021-12

#### Study First Post Date
**Date:** 2016-09-27
**Type:** ESTIMATED
**Study First Submit Date:** 2016-08-01
**Study First Submit QC Date:** 2016-09-23
**Why Stopped:** difficulty in recruiting
### 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:** In France, almost 1 death on 50 is a suicide. The suicide occurs in unbearable psychic pain where mental trouble has a major influence. It is classified as preventable mortality. According to interpersonal psychological theory of suicide, the repeated exposition to stressful and painful events (as physical abuse) would facilitate suicide attempt through the increased pain tolerance. The social pain (or psychical pain on the broader sense) and physical pain are closely linked.

The investigators hypothesize that the measure of painful perception will be significantly superior on suicidals attempters compared to non-attempters. It will be the case for recent suicide attempters and former suicide attempters, suggesting a suicidal vulnerability trait. Moreover, the investigators expect that social distress induced by a social exclusion paradigm will be significantly superior on suicide attempters compared to non-attempters.

The aim of the study is to investigate the physical and psychic pain on depressed subjects with or without history of suicide attempts.

After a clinical evaluation (psychiatric symptomatology, personality trait, suicidal dimension), subjects will be submitted to a painful thermic stimulation and will participate at a computer test of social exclusion (named Cyberball).

**Detailed Description:** 242 depressed patients ( 81 recent suicide attempters, 81 former suicide attempters, 80 non-attempters)

First visit : clinical assessment Second visit : pain evaluation and blood sample (from one day to a week maximum after the first visit).

### Conditions Module

**Conditions:**

- Major Depressive Episode

**Keywords:**

- Suicidal behavior

- psychological and social pain

- physical pain

- pain perception

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 167

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** All the participants performed blood sample for genetic purpose, psychiatric assessment and pain investigation:

* 81 depressed patients admitted after a recent suicidal act (\<8 days)
* 81 depressed subjects with a past history of suicidal act (\>1month)
* 80 depressed subjects without any personal history of suicidal behaviour

**Intervention Names:**

- Other: Blood sample for genetic purpose, psychiatric assessment and pain investigation

**Label:** Study participant

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Study participant

**Description:** All the participant will performed the same evaluation and blood analysis:

* A clinical assessment by psychiatrics assessing psychiatric disorder and suicidal behavior
* Thermal stimulation for pain assessment
* Computer game named Cyberball: test of social exclusion
* Self report questionnaire for the assessment of reject sensitivity, relationship style, impulsivity, childhood trauma.
* Routine blood sampling

**Name:** Blood sample for genetic purpose, psychiatric assessment and pain investigation

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** temperature measured when the subject will perceive as intolerable the pain following a painful stimulation performed using a thermode

**Measure:** Pain tolerance reported by the patient

**Time Frame:** During thermal stimulation

#### Secondary Outcomes

**Description:** comparison between the three groups of the pain intensity (assessed by likert scale) at constant temperature (43 ° C)

**Measure:** Pain intensity reported by the patient

**Time Frame:** During thermal stimulation

**Description:** comparison between the three groups of the pain threshold (temperature perceived as painful)

**Measure:** Pain threshold reported by the patient

**Time Frame:** During thermal stimulation

**Description:** comparison between the three groups of the temperature assessed at 4/10 on a visual analogic painful scale, kinetics of pain intensity by visual analog scale (VAS) scale.

**Measure:** Temperature assessed at 4/10 on likert scale

**Time Frame:** During thermal stimulation performed at the inclusion

**Description:** comparison between the three groups of kinetics of pain intensity by visual analog scale (VAS) scale.

**Measure:** Kinetics of pain intensity

**Time Frame:** During thermal stimulation performed at the inclusion

**Description:** comparison between the three groups of the score of social distress scale after cyberball game

**Measure:** Social distress perception assessed by social distress questionnaire

**Time Frame:** At V2 (one week maximum after the inclusion)

**Description:** comparison between the three groups of the score of social distress scale after cyberball game

**Measure:** Social distress perception assessed by the Rejection Sensitivity Questionnaire (RSQ)

**Time Frame:** At the inclusion

**Description:** comparison between the three groups of the score of social rejection sensitivity by RSQ

**Measure:** Social rejection sensitivity assessed by the Rejection Sensitivity Questionnaire (RSQ)

**Time Frame:** At the inclusion

**Description:** comparison between the three groups of the score of psychological pain intensity assessed by VAS scale.

**Measure:** Psychological pain intensity

**Time Frame:** At V2 (one week maximum after the inclusion)

**Description:** comparison between the three groups of the cardiac frequency.

**Measure:** Measure of cardiac frequency in response to thermal pain

**Time Frame:** At V2 (one week maximum after the inclusion)

### Eligibility Module

**Eligibility Criteria:** Inclusion criteria:

* aged by 18 years old
* came from West Europe, excepted Basque and Sardinian (because of genetics analysis)
* main diagnosis of major depressive episode (DSM V criteria)
* not having take antalgics in the 24 hours before assessment
* received a minimal psychotrope treatment (clinician evaluation)
* Able to understand nature, aims, methodology of the study
* Agree to cooperate in clinical and biological assessment
* Having signed informed consent

Specific inclusion criteria :

81 recent suicide attempters (being hospitalised for suicidal attempts and having realised a suicide attempts 8 days before inclusion) 81 former suicide attempters (having realised in his lifetime a suicide attempt, one month before inclusion)

Exclusion criteria:

* Current diagnosis of manic, hypomanic or alcohol dependance or substance abuse in the last 6 months, or diagnosis of schizophrenia or schizoaffective disorder in his lifetime
* Current algic and chronic neurologic disease
* Current or actual treatment by tricyclic antidepressant and Serotonin and norepinephrine reuptake inhibitors(SNRIs)
* Pregnancy
* Patients on protective measure

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Montpellier

**Country:** France

**Facility:** Montpellier Hospital University

**Zip:** 34295

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
