Ignite Creation Date:
2024-05-06 @ 2:55 PM
Last Modification Date:
2024-10-26 @ 1:39 PM
Study NCT ID:
NCT04461327
Status:
RECRUITING
Last Update Posted:
2023-11-28
First Post:
2020-07-02
Brief Title:
Psychophysiological Study of Pain Perception in Depressed Patients With Suicidal Risk
Sponsor:
University Hospital Montpellier
Organization:
University Hospital Montpellier
Study Overview
Official Title:
Psychophysiological Study of Pain Perception in Depressed Patients With Suicidal Risk
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
R2D2
Brief Summary:
Joiners 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 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 synapseIn recent suicidal patients an increase of the CPM could explain higher pain tolerance
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 The threshold of Aδ and C nociceptors If a nociceptive fiber is less excitable than the other it would explain higher pain threshold
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 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 synapseIn recent suicidal patients an increase of the CPM could explain higher pain tolerance
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 The threshold of Aδ and C nociceptors If a nociceptive fiber is less excitable than the other it would explain higher pain threshold
Detailed Description:
Aim The first objective of this project is to test different pain mechanisms that could be involved in the increase of pain thresholds and tolerance in suicidal patients The second objective is to test whether theres a loss of pleasantness during social touch in suicidal patients
The main aim is to compare the efficacity of CPM between three groups of depressed patients recent or former suicide attempters and non-attempters The secondary aims are 1 to compare the wind-up mechanism between groups 2 to compare the difference of excitability of Aδ and C fibers between groups 3 to correlate these physiological results to clinical variables emotional reactivity and emotional regulation dissociation and body perception and 4 to compare the pleasantness associated with social touch between groups
Target population 153 depressed women will be enrolled and divided into three groups I Women having recently attempted suicide less than 72 hours - II women having a past suicide attempt more than 72 hours - III Women without lifetime history of suicidal behaviour affective control group
Materials The heat test stimuli are performed by a thermode TCS II QST Lab which produces ramping heat pulses from 32C to 52C For the conditioning stimulus cold pressor task participants will insert their arm up to the elbow in circulating cold water 8C Pain intensity is rated by a CoVAS computer visual analog scale This scale is similar to a classic visual analog scale VAS ranging from no pain to the most intense pain tolerable The participant has just to move a cursor thanks to the computer mouse The stroking is performed thanks to a Natural hair Blush Brush No 7 The Boots Company
Clinical assessment A clinical assessment will be made by a trained researcher This assessment will evaluate psychiatric diagnosis by the DSM-V Diagnostic and Statistical Manual of Mental Disorders the severity of depression by the IDS-C30 Inventory of Depressive Symptomatology the intensity of suicidal thoughts by the CSSRS Columbia Suicide Severity Rating Scale and the suicidal life history by the RRRS Risk-Rescue Rating Scale and SIS Suicidal Intent Scales It will also gather information about socio-demographic variables the number of depressed episodes the number of psychiatric hospitalizations the hormonal status and the current medications All psychotropics medications taken by the patient will be collected for the last 72 hours as well as the dose and the date of the beginning of the treatment The patients will also have to complete some self-report measures about the severity of their depression BDI-II their level of anxiety STAI their physical and psychological pain EVA current and past their childhood trauma CTQ their emotional state PANAS their difficulty in emotional regulation DERS their emotional reactivity ERS their body perception BIS their dissociative experiences their borderline symptomatology BSL-23 and the kind of non-suicidal self-injuries practiced SHI
Blood tests 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 andor lithium and to measure complete blood count CBC
Experimental design All three pain mechanisms and social touch will be tested in one session lasting 1h approximately
1 To distinguish the threshold of Aδ and C a thermal stimulus will be used to provoke painful and non-painful sensations Thermode QST lab Successive and alternate phases of painful hot and non-painful warm stimulations will be used The warm phase will remain stable at 38C for 5 seconds whereas the hot phase will consist of ascending heat pulses from 39C to 52C for 1 second each At every phase the participant will be asked if she feels pain or not to determine the pain threshold The Aδ fiber threshold will be the first time when the participant will report pain during the hot phase The C fiber threshold will be the first time when the participant will report pain during the warm phase These measures will be repeated five times
2 Wind-up and CPM will be evaluated successively in three steps
1 To measure the activity of the wind-up a constant temperature individually determined will be applied during 2 minutes on the left forearm stimulus test This temperature will correspond to a painful sensation of 40100 on the CoVAS for each patient previously evaluated During the test the participant will report the intensity of pain on the CoVAS in a continuous manner The patient will move the cursor along the continuous line to indicate the pain she feels and every change
2 The CPM activation will be produced by a counter nociceptive stimulation cold pressor task The right forearm of the participant will be placed during 2 minutes in a cold water maintained at 8C conditioning stimulus
3 To measure the efficiency of the CPM the hot constant temperature corresponding to CoVAS 40100 will be re-applied during 2 minutes on the left forearm conditioned stimulus As previously participant will report her pain on the CoVAS
Before and after the painful tests the participant will have to complete two self-report measures The PANAS to evaluate their emotional state and the STAI state to evaluate their anxiety
In a final step the pleasure associated with social touch will be tested The experimenter stroked the participants marked skin areas for 70 seconds with a soft brush in either CT-optimal speed 3 cms slow touch group associated with pleasantness or non-CT-optimal speed 18 cms fast touch group associated with a neutral feeling The pleasure associated with the stroke is then assessed on a 10-point Likert scale from really unpleasant to really pleasant In this within design the reaped measures slow touch vs fast touch will be counterbalanced between participants
Pairing A pairing will be made on age and antidepressant class none selective serotonin reuptake inhibitor SSRI Serotonin-norepinephrine reuptake inhibitor SNRI tricyclic others For each category of antidepressant a 1 will be attributed if the patient takes one medication of this category and a 0 if not In each group the sum of every classes of medication will have to be equal As a reminder class of antidepressant are exclusive between them
Medical load To control medication a medication load index will be calculated as described in Olié and al 2018 Antiepileptics and lithium medications will be dosed in plasma
There is an ancillary study associate with this project ID RCB 2023-A00213-42 His main objective is to evaluate the rested functional connectivity between saliencys network areas associated to pain sensitivity in patient presenting a characterized depressive episode with or without Suicide Attempt on his entire life 50 patients are concerned This study is charaterized by a third visit during which a MRI is done
The main aim is to compare the efficacity of CPM between three groups of depressed patients recent or former suicide attempters and non-attempters The secondary aims are 1 to compare the wind-up mechanism between groups 2 to compare the difference of excitability of Aδ and C fibers between groups 3 to correlate these physiological results to clinical variables emotional reactivity and emotional regulation dissociation and body perception and 4 to compare the pleasantness associated with social touch between groups
Target population 153 depressed women will be enrolled and divided into three groups I Women having recently attempted suicide less than 72 hours - II women having a past suicide attempt more than 72 hours - III Women without lifetime history of suicidal behaviour affective control group
Materials The heat test stimuli are performed by a thermode TCS II QST Lab which produces ramping heat pulses from 32C to 52C For the conditioning stimulus cold pressor task participants will insert their arm up to the elbow in circulating cold water 8C Pain intensity is rated by a CoVAS computer visual analog scale This scale is similar to a classic visual analog scale VAS ranging from no pain to the most intense pain tolerable The participant has just to move a cursor thanks to the computer mouse The stroking is performed thanks to a Natural hair Blush Brush No 7 The Boots Company
Clinical assessment A clinical assessment will be made by a trained researcher This assessment will evaluate psychiatric diagnosis by the DSM-V Diagnostic and Statistical Manual of Mental Disorders the severity of depression by the IDS-C30 Inventory of Depressive Symptomatology the intensity of suicidal thoughts by the CSSRS Columbia Suicide Severity Rating Scale and the suicidal life history by the RRRS Risk-Rescue Rating Scale and SIS Suicidal Intent Scales It will also gather information about socio-demographic variables the number of depressed episodes the number of psychiatric hospitalizations the hormonal status and the current medications All psychotropics medications taken by the patient will be collected for the last 72 hours as well as the dose and the date of the beginning of the treatment The patients will also have to complete some self-report measures about the severity of their depression BDI-II their level of anxiety STAI their physical and psychological pain EVA current and past their childhood trauma CTQ their emotional state PANAS their difficulty in emotional regulation DERS their emotional reactivity ERS their body perception BIS their dissociative experiences their borderline symptomatology BSL-23 and the kind of non-suicidal self-injuries practiced SHI
Blood tests 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 andor lithium and to measure complete blood count CBC
Experimental design All three pain mechanisms and social touch will be tested in one session lasting 1h approximately
1 To distinguish the threshold of Aδ and C a thermal stimulus will be used to provoke painful and non-painful sensations Thermode QST lab Successive and alternate phases of painful hot and non-painful warm stimulations will be used The warm phase will remain stable at 38C for 5 seconds whereas the hot phase will consist of ascending heat pulses from 39C to 52C for 1 second each At every phase the participant will be asked if she feels pain or not to determine the pain threshold The Aδ fiber threshold will be the first time when the participant will report pain during the hot phase The C fiber threshold will be the first time when the participant will report pain during the warm phase These measures will be repeated five times
2 Wind-up and CPM will be evaluated successively in three steps
1 To measure the activity of the wind-up a constant temperature individually determined will be applied during 2 minutes on the left forearm stimulus test This temperature will correspond to a painful sensation of 40100 on the CoVAS for each patient previously evaluated During the test the participant will report the intensity of pain on the CoVAS in a continuous manner The patient will move the cursor along the continuous line to indicate the pain she feels and every change
2 The CPM activation will be produced by a counter nociceptive stimulation cold pressor task The right forearm of the participant will be placed during 2 minutes in a cold water maintained at 8C conditioning stimulus
3 To measure the efficiency of the CPM the hot constant temperature corresponding to CoVAS 40100 will be re-applied during 2 minutes on the left forearm conditioned stimulus As previously participant will report her pain on the CoVAS
Before and after the painful tests the participant will have to complete two self-report measures The PANAS to evaluate their emotional state and the STAI state to evaluate their anxiety
In a final step the pleasure associated with social touch will be tested The experimenter stroked the participants marked skin areas for 70 seconds with a soft brush in either CT-optimal speed 3 cms slow touch group associated with pleasantness or non-CT-optimal speed 18 cms fast touch group associated with a neutral feeling The pleasure associated with the stroke is then assessed on a 10-point Likert scale from really unpleasant to really pleasant In this within design the reaped measures slow touch vs fast touch will be counterbalanced between participants
Pairing A pairing will be made on age and antidepressant class none selective serotonin reuptake inhibitor SSRI Serotonin-norepinephrine reuptake inhibitor SNRI tricyclic others For each category of antidepressant a 1 will be attributed if the patient takes one medication of this category and a 0 if not In each group the sum of every classes of medication will have to be equal As a reminder class of antidepressant are exclusive between them
Medical load To control medication a medication load index will be calculated as described in Olié and al 2018 Antiepileptics and lithium medications will be dosed in plasma
There is an ancillary study associate with this project ID RCB 2023-A00213-42 His main objective is to evaluate the rested functional connectivity between saliencys network areas associated to pain sensitivity in patient presenting a characterized depressive episode with or without Suicide Attempt on his entire life 50 patients are concerned This study is charaterized by a third visit during which a MRI is done
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None