NCT05182827

Brief Summary

Several elements suggest that suicidal vulnerability may be associated with an alteration in the perception of affective touch. On the one hand, anhedonia, characterized by a decrease in the pleasure felt, is strongly associated with suicidal ideation, independently of depression. However, the ability to feel pleasure is essential in the perception of affective touch. On the other hand, suicidal behaviors are associated with interpersonal difficulties, of which communication is an integral part, and communication is partly through touch. The investigators therefore wish to explore the perception of affective touch in suicidal behavior by using an affective tactile stimulation in 72 subjects with and without a history of suicide attempts (SA).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

December 22, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 10, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

February 11, 2022

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 9, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 9, 2024

Completed
Last Updated

January 10, 2025

Status Verified

January 1, 2025

Enrollment Period

2.6 years

First QC Date

December 22, 2021

Last Update Submit

January 8, 2025

Conditions

Keywords

SuicideDepressionAffective touchDecision making

Outcome Measures

Primary Outcomes (1)

  • Pleasantness of the touch

    Perceived pleasantness of the tactile stimulation, assessed with a numeric scale ranging from -5 (very unpleasant) to +5 (very pleasant)

    at inclusion

Secondary Outcomes (5)

  • Intensity of the touch

    at inclusion

  • Decision-making performance (Iowa Gambling Test)

    at inclusion

  • Decision-making performance (Ultimatum Game)

    at inclusion

  • β-endorphin levels

    at inclusion

  • Variation in the expression of opioidergic genes

    at inclusion

Study Arms (2)

Euthymic patients with history of suicide attempt (suicide attempters)

EXPERIMENTAL

Currently euthymic patients with at least one lifetime major depressive episode and a history of suicide attempts

Other: Tactile stimulation

Euthymic patients without any history of suicide attempt (affective controls)

EXPERIMENTAL

Currently euthymic patients with at least one lifetime major depressive episode and with no history of suicide attempts

Other: Tactile stimulation

Interventions

The experimental task aims to evaluate the hedonic nature of an affective touch by tactile stimulation. It consists in stimulating two adjacent regions of the left forearm, delimited and marked, of 9 cm x 4 cm each. In order to limit habituation, the stimulation areas will be alternated. To stimulate these areas, the investigator (previously trained) strokes the participant with a brush at an optimal speed to stimulate the C-fibers (3 cm/s; slow speed) or not (18 cm/s; fast speed). Touch will consist of 30 seconds blocks of stimulation, performed on one of the two identified areas, from the elbow to the wrist. In total, 6 stimulation blocks will be done (3 slow and 3 fast), the order and location of which will be random in order to limit habituation. This stimulation is completely painless. After each block, the participant will evaluate the intensity of the stimulation and its pleasantness.

Euthymic patients with history of suicide attempt (suicide attempters)Euthymic patients without any history of suicide attempt (affective controls)

Eligibility Criteria

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

You may qualify if:

  • Being a woman
  • Aged between 18 and 65
  • Past major depressive episode according to the DSM-5 criteria
  • Currently euthymic (Montgomery-Asberg Depression rating Scale (MADRS) \< 12 and Young Mania Rating Scale (YMRS) \< 6)
  • Minimal psychotropic medication (as determined by the clinician)
  • Able to understand experimental procedures
  • Able to speak, read and understand French
  • Having given written informed consent
  • For suicide attempters only: Lifetime history of suicide attempt
  • For affective controls only: No lifetime history of suicide attempt

You may not qualify if:

  • Lifetime diagnosis of schizoaffective disorder, schizophrenia or autism spectrum disorder
  • Severe alcohol or substance use disorder in the past 6 months
  • Current anorexia nervosa
  • Diagnosis of mental retardation or severe medical comorbidity that is unstable or could interfere with measures (HIV, diabetes, cancer, chronic inflammatory disease, neurological disorder, sensory or cognitive disability)
  • Injury, scar, irritation/dermatological lesion or tattoo on the left forearm
  • Pregnancy or breastfeeding
  • Not being affiliated to the French National Social Security System
  • Being deprived of freedom (by judicial or administrative decision)
  • Being protected by law (guardianship or curatorship)
  • Having reached 4500€ annual compensation for participating to clinical trials

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montpellier University Hospital, France (CHU)

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Self-Injurious BehaviorSuicideDepression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2021

First Posted

January 10, 2022

Study Start

February 11, 2022

Primary Completion

September 9, 2024

Study Completion

September 9, 2024

Last Updated

January 10, 2025

Record last verified: 2025-01

Locations