Major Depressive EpisodeDOCSNCT02915679
Pain Perception in Suicidal Behavior Vulnerability
A study testing Blood sample for genetic purpose, psychiatric assessment and pain investigation in people with Major Depressive Episode, run by University Hospital, Montpellier at 1 site in France.
Trial summary
In France, almost 1 death on 50 is a suicide. The suicide occurs in unbearable psychic pain where mental trouble has a major influence. It is classified as preventable mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Episode
- What is being tested?
- Blood sample for genetic purpose, psychiatric assessment and pain investigation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jun 2015to 6 May 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged by 18 years old
- came from West Europe, excepted Basque and Sardinian (because of genetics analysis)
- main diagnosis of major depressive episode (DSM V criteria)
- not having take antalgics in the 24 hours before assessment
- received a minimal psychotrope treatment (clinician evaluation)
- Able to understand nature, aims, methodology of the study
Show all 10Show fewer
- Agree to cooperate in clinical and biological assessment
- Having signed informed consent
- Specific inclusion criteria :
- 81 recent suicide attempters (being hospitalised for suicidal attempts and having realised a suicide attempts 8 days before inclusion) 81 former suicide attempters (having realised in his lifetime a suicide attempt, one month before inclusion)
Who cannot join
- Current diagnosis of manic, hypomanic or alcohol dependance or substance abuse in the last 6 months, or diagnosis of schizophrenia or schizoaffective disorder in his lifetime
- Current algic and chronic neurologic disease
- Current or actual treatment by tricyclic antidepressant and Serotonin and norepinephrine reuptake inhibitors(SNRIs)
- Pregnancy
- Patients on protective measure
Trial locations and contacts
1 site in 1 country.
About this study
In France, almost 1 death on 50 is a suicide. The suicide occurs in unbearable psychic pain where mental trouble has a major influence. It is classified as preventable mortality. According to interpersonal psychological theory of suicide, the repeated exposition to stressful and painful events (as physical abuse) would facilitate suicide attempt through the increased pain tolerance. The social pain (or psychical pain on the broader sense) and physical pain are closely linked.
The investigators hypothesize that the measure of painful perception will be significantly superior on suicidals attempters compared to non-attempters. It will be the case for recent suicide attempters and former suicide attempters, suggesting a suicidal vulnerability trait. Moreover, the investigators expect that social distress induced by a social exclusion paradigm will be significantly superior on suicide attempters compared to non-attempters.
Read more
The aim of the study is to investigate the physical and psychic pain on depressed subjects with or without history of suicide attempts.
After a clinical evaluation (psychiatric symptomatology, personality trait, suicidal dimension), subjects will be submitted to a painful thermic stimulation and will participate at a computer test of social exclusion (named Cyberball).
Read the detailed description
242 depressed patients ( 81 recent suicide attempters, 81 former suicide attempters, 80 non-attempters)
First visit : clinical assessment Second visit : pain evaluation and blood sample (from one day to a week maximum after the first visit).
- Conditions
- Major Depressive Episode
- Being tested
- Blood sample for genetic purpose, psychiatric assessment and pain investigation
- Keywords
- Suicidal behavior, psychological and social pain, physical pain, pain perception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample for genetic purpose, psychiatric assessment and pain investigationOther
All the participant will performed the same evaluation and blood analysis:
- A clinical assessment by psychiatrics assessing psychiatric disorder and suicidal behavior
- Thermal stimulation for pain assessment
- Computer game named Cyberball: test of social exclusion
- Self report questionnaire for the assessment of reject sensitivity, relationship style, impulsivity, childhood trauma.
- Routine blood sampling
| Study group | Role | What they receive |
|---|---|---|
| Study participant | Other | All the participants performed blood sample for genetic purpose, psychiatric assessment and pain investigation:
* 81 depressed patients admitted after a recent suicidal act (<8 days)
* 81 depressed subjects with a past history of suicidal act (>1month)
* 80 depressed subjects without any personal history of suicidal behaviour Receives: Other: Blood sample for genetic purpose, psychiatric assessment and pain investigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain tolerance reported by the patient
temperature measured when the subject will perceive as intolerable the pain following a painful stimulation performed using a thermode
Measured: During thermal stimulation
Secondary outcomes (9)
Pain intensity reported by the patient
comparison between the three groups of the pain intensity (assessed by likert scale) at constant temperature (43 ° C)
Measured: During thermal stimulation
Pain threshold reported by the patient
comparison between the three groups of the pain threshold (temperature perceived as painful)
Measured: During thermal stimulation
Temperature assessed at 4/10 on likert scale
comparison between the three groups of the temperature assessed at 4/10 on a visual analogic painful scale, kinetics of pain intensity by visual analog scale (VAS) scale.
Measured: During thermal stimulation performed at the inclusion
Kinetics of pain intensity
comparison between the three groups of kinetics of pain intensity by visual analog scale (VAS) scale.
Measured: During thermal stimulation performed at the inclusion
Social distress perception assessed by social distress questionnaire
comparison between the three groups of the score of social distress scale after cyberball game
Measured: At V2 (one week maximum after the inclusion)
Social distress perception assessed by the Rejection Sensitivity Questionnaire (RSQ)
comparison between the three groups of the score of social distress scale after cyberball game
Measured: At the inclusion
Social rejection sensitivity assessed by the Rejection Sensitivity Questionnaire (RSQ)
comparison between the three groups of the score of social rejection sensitivity by RSQ
Measured: At the inclusion
Psychological pain intensity
comparison between the three groups of the score of psychological pain intensity assessed by VAS scale.
Measured: At V2 (one week maximum after the inclusion)
Measure of cardiac frequency in response to thermal pain
comparison between the three groups of the cardiac frequency.
Measured: At V2 (one week maximum after the inclusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2016 (estimated)
- Study start17 Jun 2015
- Primary completion6 May 2021
- Study completion6 May 2021
Why it stopped: difficulty in recruiting
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 167 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
- NCT02915679
- Sponsor's protocol ID
- UF 9185
- Other IDs
- 2013-A01029-36
- Acronym
- DOCS
- Status last verified
- Dec 2021
- First submitted
- 1 Aug 2016
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Perception in Suicidal Behavior Vulnerability
- ClinicalTrials.gov ID
- NCT02915679
- Acronym / sponsor ID
- DOCS / UF 9185
- Conditions
- Major Depressive Episode
- Keywords
- Suicidal behavior, psychological and social pain, physical pain, pain perception
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficulty in recruiting
- Enrolment
- 167 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 17 Jun 2015
- Primary completion
- 6 May 2021 (actual)
- Study completion
- 6 May 2021 (actual)
- First posted
- 27 Sep 2016 (estimated)
- 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.
In France, almost 1 death on 50 is a suicide. The suicide occurs in unbearable psychic pain where mental trouble has a major influence. It is classified as preventable mortality. According to interpersonal psychological theory of suicide, the repeated exposition to stressful and painful events (as physical abuse) would facilitate suicide attempt through the increased pain tolerance. The social pain (or psychical pain on the broader sense) and physical pain are closely linked.
The investigators hypothesize that the measure of painful perception will be significantly superior on suicidals attempters compared to non-attempters. It will be the case for recent suicide attempters and former suicide attempters, suggesting a suicidal vulnerability trait. Moreover, the investigators expect that social distress induced by a social exclusion paradigm will be significantly superior on suicide attempters compared to non-attempters.
The aim of the study is to investigate the physical and psychic pain on depressed subjects with or without history of suicide attempts.
After a clinical evaluation (psychiatric symptomatology, personality trait, suicidal dimension), subjects will be submitted to a painful thermic stimulation and will participate at a computer test of social exclusion (named Cyberball).
Detailed description
242 depressed patients ( 81 recent suicide attempters, 81 former suicide attempters, 80 non-attempters)
First visit : clinical assessment Second visit : pain evaluation and blood sample (from one day to a week maximum after the first visit).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study participant | Other | Other: Blood sample for genetic purpose, psychiatric assessment and pain investigationAll the participants performed blood sample for genetic purpose, psychiatric assessment and pain investigation: * 81 depressed patients admitted after a recent suicidal act (<8 days) * 81 depressed subjects with a past history of suicidal act (>1month) * 80 depressed subjects without any personal history of suicidal behaviour |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- aged by 18 years old
- came from West Europe, excepted Basque and Sardinian (because of genetics analysis)
- main diagnosis of major depressive episode (DSM V criteria)
- not having take antalgics in the 24 hours before assessment
- received a minimal psychotrope treatment (clinician evaluation)
Key exclusion criteria (5 listed)
- Current diagnosis of manic, hypomanic or alcohol dependance or substance abuse in the last 6 months, or diagnosis of schizophrenia or schizoaffective disorder in his lifetime
- Current algic and chronic neurologic disease
- Current or actual treatment by tricyclic antidepressant and Serotonin and norepinephrine reuptake inhibitors(SNRIs)
- Pregnancy
- Patients on protective measure
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 |
|---|---|---|
| Blood sample for genetic purpose, psychiatric assessment and pain investigationAll the participant will performed the same evaluation and blood analysis: * A clinical assessment by psychiatrics assessing psychiatric disorder and suicidal behavior * Thermal stimulation for pain assessment * Computer game named Cyberball: test of social exclusion * Self report questionnaire for the assessment of reject sensitivity, relationship style, impulsivity, childhood trauma. * Routine blood sampling | Other | Study participant |
Primary outcome
Pain tolerance reported by the patient
Time frame: During thermal stimulation
temperature measured when the subject will perceive as intolerable the pain following a painful stimulation performed using a thermode
9 secondary outcomes
Pain intensity reported by the patient
Time frame: During thermal stimulation
Pain threshold reported by the patient
Time frame: During thermal stimulation
Temperature assessed at 4/10 on likert scale
Time frame: During thermal stimulation performed at the inclusion
Kinetics of pain intensity
Time frame: During thermal stimulation performed at the inclusion
Social distress perception assessed by social distress questionnaire
Time frame: At V2 (one week maximum after the inclusion)
Social distress perception assessed by the Rejection Sensitivity Questionnaire (RSQ)
Time frame: At the inclusion
Social rejection sensitivity assessed by the Rejection Sensitivity Questionnaire (RSQ)
Time frame: At the inclusion
Psychological pain intensity
Time frame: At V2 (one week maximum after the inclusion)
Measure of cardiac frequency in response to thermal pain
Time frame: At V2 (one week maximum after the inclusion)
Results and safety
The study was stopped early (reason given: difficulty in recruiting). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Individual participant dataSharing planned: No
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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 Blood sample for genetic purpose, psychiatric assessment and pain investigation in people with Major Depressive Episode, 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 5 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: stopped early, as of the sponsor's last update on 11 Jan 2022. 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 was stopped early (reason given: difficulty in recruiting). Results are not available in the source record.
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?
Pain tolerance reported by the patient (time frame: During thermal stimulation). 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 11 Jan 2022.