Major Depressive EpisodeTOUCH-SNCT05182827
Affective Touch, Hedonia and Suicidal Behavior
A study testing Tactile stimulation in people with Major Depressive Episode and Suicidal and Self-injurious Behavior, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Major Depressive Episode, Suicidal and Self-injurious Behavior
- What is being tested?
- Tactile stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteFrance
- Study dates
- 11 Feb 2022to 9 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the detailed description
This study aims to compare the perceived hedonic nature of affective touch in euthymic subjects with a history of SA and euthymic subjects without a history of SA.
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.
- Being tested
- Tactile stimulation
- Keywords
- Suicide, Depression, Affective touch, Decision making
- Medical subject headings
- Self-Injurious Behavior, Suicide, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tactile stimulationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Tactile stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pleasantness of the touch
Perceived pleasantness of the tactile stimulation, assessed with a numeric scale ranging from -5 (very unpleasant) to +5 (very pleasant)
Measured: at inclusion
Secondary outcomes (5)
Intensity of the touch
Perceived intensity of the tactile stimulation, assessed with a 10 points Likert scale (low intensity to high intensity).
Measured: at inclusion
Decision-making performance (Iowa Gambling Test)
Decision-making performance using the IG index from the Iowa Gambling Test (difference between the number of safe and risky choices)
Measured: at inclusion
Decision-making performance (Ultimatum Game)
Decision-making performance using the UG index from the Ultimatum Game (difference between the number of rejections of unfair and fair offers)
Measured: at inclusion
β-endorphin levels
Plasmatic levels of β-endorphin
Measured: at inclusion
Variation in the expression of opioidergic genes
Variation in mRNA levels of 6 genes coding for opioidergic receptors and peptides (OPRM1 (µ), OPRK1 (κ), OPRD1 (δ) and pro-opio-melanocortin, pro-enkephalin, pro-dynomorphin), before and after tactile stimulation
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study start11 Feb 2022
- Primary completion9 Sep 2024
- Study completion9 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive EpisodeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05182827
- Sponsor's protocol ID
- RECHMPL21_0502
- Acronym
- TOUCH-S
- Status last verified
- Jan 2025
- First submitted
- 22 Dec 2021
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Affective Touch, Hedonia and Suicidal Behavior
- ClinicalTrials.gov ID
- NCT05182827
- Acronym / sponsor ID
- TOUCH-S / RECHMPL21_0502
- Keywords
- Suicide, Depression, Affective touch, Decision making
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 11 Feb 2022 (actual)
- Primary completion
- 9 Sep 2024 (actual)
- Study completion
- 9 Sep 2024 (actual)
- First posted
- 10 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This study aims to compare the perceived hedonic nature of affective touch in euthymic subjects with a history of SA and euthymic subjects without a history of SA.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Euthymic patients with history of suicide attempt (suicide attempters) | Experimental | Other: Tactile stimulationCurrently euthymic patients with at least one lifetime major depressive episode and a history of suicide attempts |
| Euthymic patients without any history of suicide attempt (affective controls) | Experimental | Other: Tactile stimulationCurrently euthymic patients with at least one lifetime major depressive episode and with no history of suicide attempts |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tactile stimulationThe 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. | Other | Euthymic patients with history of suicide attempt (suicide attempters), Euthymic patients without any history of suicide attempt (affective controls) |
Primary outcome
Pleasantness of the touch
Time frame: at inclusion
Perceived pleasantness of the tactile stimulation, assessed with a numeric scale ranging from -5 (very unpleasant) to +5 (very pleasant)
5 secondary outcomes
Intensity of the touch
Time frame: at inclusion
Decision-making performance (Iowa Gambling Test)
Time frame: at inclusion
Decision-making performance (Ultimatum Game)
Time frame: at inclusion
β-endorphin levels
Time frame: at inclusion
Variation in the expression of opioidergic genes
Time frame: at inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tactile stimulation in people with Major Depressive Episode and Suicidal and Self-injurious Behavior, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pleasantness of the touch (time frame: at inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2025.