Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
72 participants
INTERVENTIONAL
2022-02-11
2024-09-09
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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).
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Psychophysiological Study of Pain Perception in Depressed Patients With Suicidal Risk
NCT04461327
Predictors of Suicidal Behavior in Depression
NCT02904005
Neuroinflammation, Serotonin, Impulsivity and Suicide
NCT02824081
Cognition, Sleep, Neurophysiology of Suicidal Depressed Patients
NCT04813835
Loneliness and Occurrence of Suicide Attempts and Suicidal Ideas
NCT02829671
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The investigators also aim to :
* compare the perceived hedonic nature of non-affective touch in this population;
* compare the perceived intensity of affective touch;
* compare the perceived intensity of non-affective touch;
* study the association between decision making performance and perceived pleasantness of affective vs. non-affective touch;
* study the association between plasma beta-endorphin levels and the perceived pleasantness of affective vs. non-affective touch;
* study the effect of the tactile stimulation on the expression of opioidergic genes, by comparing the mRNA levels of 6 genes coding for opioidergic receptors and peptides before and after tactile stimulation;
* investigate the association between tactile stimulation-related opioidergic gene expression variation and the perception of the pleasantness of affective versus non-affective touch.
To do so, 72 euthymic women will be included and divided in two groups: 1) Euthymic patients with a lifetime history of major depressive episode and a history of suicidal behavior; 2) Euthymic patients with a lifetime history of a major depressive episode and no history of suicidal behavior.
Participants will be subjected to tactile stimulation (affective and non-affective), following a clinical and neurospychological assessment. During the experimental touch, participants will be asked to evaluate the pleasantness of the touch and its intensity. In addition, blood samples will be taken before and after the stimulation.
Participation will be done in one day or in two visits, up to 72 hours apart.
The investigators expect: 1) subjects with a history of TS to have a decreased perceived pleasantness of affective touch compared to subjects without a history of TS; 2) the difference between the perceived pleasantness of affective versus non-affective touch to be smaller in patients with a history of TS; 3) decision making to be related to the hedonic nature of affective touch; 4) a change in the expression of opioidergic genes.
This study will contribute to a better knowledge of the vulnerability to suicidal behaviors and to a better understanding of psychopathology in order to offer specific and more adapted prevention and management strategies.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Euthymic patients with history of suicide attempt (suicide attempters)
Currently euthymic patients with at least one lifetime major depressive episode and a history of suicide attempts
Tactile stimulation
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 without any history of suicide attempt (affective controls)
Currently euthymic patients with at least one lifetime major depressive episode and with no history of suicide attempts
Tactile stimulation
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Tactile stimulation
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
* Being in exclusion period for another study
* 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
18 Years
65 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital, Montpellier
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Montpellier University Hospital, France (CHU)
Montpellier, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RECHMPL21_0502
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.