NCT04461327

Brief Summary

Joiner's interpersonal theory of suicide postulates that the wish of death comes from feelings of perceived burdensomeness and thwarted belongingness. But, only people who have acquired the capability to kill themselves will attempt suicide. The acquired capability refers to a reduction of fear to death, and a higher pain tolerance. Indeed, to commit suicide involves to endure pain during the act. Thus, higher pain tolerance seems to be a necessary feature for suicidal act. Past studies have shown higher pain threshold and tolerance in suicidal patients, whatever the stimulus was (electric, thermic or mechanical), compared to patients without suicide history. Moreover, Caceda and colleagues demonstrated higher pain threshold in recent suicide attempters (suicidal act within 72h) compared with depressed patients. Five days after the initial evaluation, pain threshold of recent suicide attempters decreased to be similar to depressed patients with suicidal ideation. Therefore, it may exist a specific state during which the pain tolerance is increased. During this "hypoalgesic state" patients with suicidal ideation could attempt suicide to get relief from suffering. However, little is known about the specific mechanisms that are responsible for the higher pain threshold and tolerance in suicide attempters. Pain is a dynamic system that results from excitatory and inhibitory messages. The modification of one of these mechanisms could explain the higher tolerance in recent suicide attempters. Three of them are of particular interest:

  1. 1.The conditioned pain modulation (CPM) is a modulatory pain mechanism. CPM works through descending pathway that reaches the spinal cord and modulates pain processing from the first nociceptive synapse.In recent suicidal patients, an increase of the CPM could explain higher pain tolerance.
  2. 2.The "wind-up" mechanism is defined as the highest excitability of the second order nerve. Even if the stimulus remains stable, pain continuously raises. In recent suicide attempters, a reduction of this mechanism could explain higher pain tolerance.
  3. 3.The threshold of Aδ and C nociceptors. If a nociceptive fiber is less excitable than the other, it would explain higher pain threshold.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P75+ for not_applicable major-depressive-disorder

Timeline
Completed

Started Nov 2020

Typical duration for not_applicable major-depressive-disorder

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 2, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 8, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

November 25, 2020

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2024

Completed
Last Updated

March 25, 2025

Status Verified

March 1, 2025

Enrollment Period

3.2 years

First QC Date

July 2, 2020

Last Update Submit

March 20, 2025

Conditions

Keywords

PainPain modulationSuicideAffective touch

Outcome Measures

Primary Outcomes (1)

  • Effectiveness of the conditioned pain modulation

    The criterion will be the average difference of perceived pain (CoVAS measure) before and after modulation, i.e. before and after the cold pressor task. It's postulated that recent suicidal patients will have a higher efficacity of CPM than past suicidal patients and depressed affective controls.

    During painful stimulations which are assessed 24 hours after the inclusion

Secondary Outcomes (9)

  • Effectiveness of the Wind-up mechanism

    During painful stimulations which are assessed 24 hours after the inclusion

  • Aδ and C fibers thresholds

    During painful stimulations which are assessed 24 hours after the inclusion

  • Pleasantness associated with social touch

    During painful stimulations which are assessed 24 hours after the inclusion

  • Emotional Reactivity Score

    At inclusion

  • Emotional Regulation Score

    At inclusion

  • +4 more secondary outcomes

Study Arms (1)

Major Depressive patients

EXPERIMENTAL

3 groups: * Women having recently attempted suicide (less than 72 hours). * Women having a past suicide attempt (more than 72 hours). * Women without lifetime history of suicidal behaviour.

Behavioral: Painful stimulations of major depressive patientsBiological: Blood sampleDiagnostic Test: Clinical assessmentBehavioral: Social touch

Interventions

All three pain mechanisms will be tested in one session lasting 1h approximately. The mechanisms are tested in the following order: 1. Aδ and C threshold 2. Wind-up 3. CPM (more details in detailed description)

Major Depressive patients
Blood sampleBIOLOGICAL

The blood test is made between 2 and 24 hours before the experimental procedure. The biological collection is made to measure medications' concentration if the patient takes antiepileptics and/or lithium, and to measure complete blood count (CBC).

Major Depressive patients
Clinical assessmentDIAGNOSTIC_TEST

A clinical assessment will be made by a trained researcher. (more details in detailed description)

Major Depressive patients
Social touchBEHAVIORAL

Stroking

Major Depressive patients

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Woman;
  • Being aged between 18 and 65 years;
  • Currently meeting the DSM-5 major depressive episode criteria;
  • Being able to understand the nature, purpose and methodology of the study and agreeing to cooperate during the assessments;
  • Having signed informed consent;
  • Being affiliated with a social security or equivalent.
  • Recent attempters: women having recently attempted suicide (less than 72 hours)
  • Past attempters: women having a past suicide attempt (more than 72 hours)
  • Affective control: women without lifetime history of suicidal behaviour (affective control group).

You may not qualify if:

  • Existence of current psychotic or mixed characteristics;
  • Lifetime history of schizoaffective disorder or schizophrenia;
  • Current substance dependence (within the last 6 months);
  • Existence of mental retardation or serious medical comorbidity interfering with measures (HIV, diabetes, cancer, chronic inflammatory pathology, neurological disorder);
  • Having taken painkillers within the last 24 hours preceding the evaluation;
  • Existence of a usual or current treatment with analgesics or NSAIDs (daily analgesic treatment more than 3 months);
  • Existence of a sensory or cognitive handicap;
  • Pregnant or lactating woman.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital of Montpellier

Montpellier, Occitanie, 34295, France

Location

Clinic La Lironde

Saint-Gély-du-Fesc, Occitanie, 34981, France

Location

MeSH Terms

Conditions

Depressive Disorder, MajorPainSuicide

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSelf-Injurious BehaviorBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Emilie Olie, MD-PhD

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: Painful stimulations (see detailed description)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2020

First Posted

July 8, 2020

Study Start

November 25, 2020

Primary Completion

February 21, 2024

Study Completion

February 21, 2024

Last Updated

March 25, 2025

Record last verified: 2025-03

Locations