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临床试验/NCT04461327
NCT04461327终止不适用

Psychophysiological Study of Pain Perception in Depressed Patients With Suicidal Risk

University Hospital, Montpellier2 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2020年11月25日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
终止
入组人数
144
试验地点
2
主要终点
Effectiveness of the conditioned pain modulation

研究概览

简要总结

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. 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. 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.

详细描述

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 there's 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 32°C to 52°C. For the conditioning stimulus (cold pressor task), participants will insert their arm (up to the elbow) in circulating cold water (8°C). 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).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

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.

干预措施: Painful stimulations of major depressive patients (Behavioral)

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.

干预措施: Blood sample (Biological)

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.

干预措施: Clinical assessment (Diagnostic Test)

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.

干预措施: Social touch (Behavioral)

结局指标

主要结局

Effectiveness of the conditioned pain modulation

时间窗: During painful stimulations which are assessed 24 hours after the inclusion

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.

次要结局

  • Aδ and C fibers thresholds(During painful stimulations which are assessed 24 hours after the inclusion)
  • Dissociative experiences score(At inclusion)
  • Effectiveness of the Wind-up mechanism(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 Regulation Score(At inclusion)
  • Body investment score(At inclusion)
  • Emotional Reactivity Score(At inclusion)
  • Functional connectivity in saliency's network (ID-RCB :2023-A00213-42)(During an IRM which is assessed 8 days after visite 1 or after inclusion until 24 months.)
  • Acquired Capability of Suicide Scale(At inclusion)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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