Unipolar DepressionSADS-CSNCT02710279
Response to Social Rejection in Suicidal Behavior
A study testing Trier Social Stress Test (TSST) and smartphone in people with Unipolar Depression, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Suicide is a major health problem that causes annually a million death worldwild. In the stress-vulnerability model, suicidal behavior (SB) results from the interaction between an individual's predisposition and stressful condition. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Unipolar Depression
- What is being tested?
- Trier Social Stress Test (TSST) and smartphone
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteFrance
- Study dates
- 19 Feb 2016to 15 Feb 2018
- 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
- Non specifics
- Female
- Between 18 and 65 years
- Main diagnosis of unipolar major depressive episode (DSM-IV criteria)
- Having signed informed consent
- Able to understand nature, aims, and methodology oh the study
Show all 9Show fewer
- Specifics :
- Having a personal history of suicidal behavior (group : depressed patient with history of SB) OR
- Not Having personal history of suicidal behavior (group : depressed patient without history of SB)
Who cannot join
- Inflammatory or intercurrent pathology
- Lifetime history of schizophrenia, or schizoaffective or bipolar disorder, according to DSM-IV criteria;
- Current diagnosis of substance abuse or dependence in the last year (excluding tobacco)
- Current organic mental disorder or mental retardation, or severe comorbid medical condition
- Participation in another clinical trial
- Pregnancy
- Not able to speak, read and understand French
- Patient on protective measures (guardianship or trusteeship)
Trial locations and contacts
1 site in 1 country.
About this study
Suicide is a major health problem that causes annually a million death worldwild. In the stress-vulnerability model, suicidal behavior (SB) results from the interaction between an individual's predisposition and stressful condition. We hypothesized that the sensitivity to social exclusion may represent a core component of the suicidal vulnerability Recent evidence also suggest that inflammatory mediators plays a critical role in SB. Furthermore, social stressors are particulary strong and specific triggers of inflammatory response.
To sum up, patients carrying a suicidal vulnerability are expected to present greater responses to social rejection in terms of inflammatory activity and psychological pain.
Read more
The aim of the study is to evaluate the psychological and inflammatory responses to a social stressor validated, the Trier Social Stress Test (TSST) . We will also investigate the moderating effect of childhood abuse, attachment, trait rejection sensitivity and social isolation.
In the second part of the study, we will also investigate the prospective association between inflammatory responses induces by laboratory paradigms of social rejection and the occurrence of social distress, suicidal ideation and psychological pain in response to social exclusion events in real life (using ecological momentary assessment).
Read the detailed description
Over one year, we will recruit 140 female outpatients suffering from a major depressive episode with (n=70) and without any history of suicide attempt (n=70) from a specialized clinic for mood disorders and SB.
First visit: clinical, biological and neuropsychological assessment Second visit: The TSST is a standardized laboratory psychosocial stress protocol that involves public speaking, role play, and mental arithmetic tasks in front of a panel of confederate judges. Blood samples will be obtained before the introduction to the TSST and immediately after and at + 30, + 60, + 90, and + 120 min. Self-ratings of emotional states, anxiety, anger and psychological pain will be completed at the same times.
Third visit: Participants will be instructed to carry a smartphone with them for one week, and to record at each alarm signal daily life events, negative emotions, psychological pain, suicidal ideas, and specific attributions to these events. Participants will be signalled five times a day during the period. Subjects will be contacted by telephone halfway through the assessment period to monitor and encourage compliance.
- Conditions
- Unipolar Depression
- Being tested
- Trier Social Stress Test (TSST), smartphone
- Keywords
- Psychiatry, Depressive disorder, Suicide
- Medical subject headings
- Depressive Disorder, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trier Social Stress Test (TSST)Behavioural
For the TSST the participants are instructed to imagine having applied for their "dream job" and that they are now invited to a job interview. Three successive phases: (1) A preparation period (3 min), (2) a free speech: explain why you are the best candidate for the job (5 min), (3) a mental arithmetic complex task (5 min). The two tasks (task 2 and 3) are performed in front of a selection committee, three persons dressed in white lab coats, acting in a reserved manner and providing no facial or verbal feedback. Additionally, participants are told that they are video-taped and told that their performance will be evaluated. (in fact, there is no video-tape, just a false camera). After the TSST, patients have to answer to a questionnaire on their smartphone, 5 times a day during 7 days.
smartphoneDevice
| Study group | Role | What they receive |
|---|---|---|
| Depressive patients | Other | Depressive patients with or without story of suicidal behavior will pass the TSST and will have a psychological assessment to complete with a questionnaire on their smartphone Receives: Behavioral: Trier Social Stress Test (TSST); Device: smartphone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological pain response to Trier Social Stress Test (TSST) assessed by visual analogic sale
comparaison of psychological pain response between group with personal history of suicid attempt and group without personal history of suicid attempt
Measured: up to one week
Secondary outcomes (4)
Inflammatory response to TTST
comparaison of blood markers of inflammation between groups
Measured: up to one week
Impact of loneliness and childhood abuse on inflammatory markers
comparaison of sacles scores (ESUL : loneliness scale and CTQ : childhood abuse scale) between groups on inflammatory markers
Measured: up to one week
impact of neuropschychological function on psychological pain
comparaison of neuropsychological tests between groups on psychological pain assessed by visual analogic scale
Measured: up to one week
Social rejection assessed by likert scale in real life condition with a smartphone
comparaison between groups whether inflammatory / psychological pain reactivity to a single experimental episode of social rejection in the laboratory relates to real-world social experience. It consists on self-assessments (with a smartphone) by Likert scales (feelings of social disconnection or rejection during their most recent social interaction, mood, negative affects, suicidal ideation, psychological pain), 5 times per day during 7 days
Measured: 7 days after the TSST
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2016 (estimated)
- Study start19 Feb 2016
- Primary completion15 Feb 2018
- Study completion15 Feb 2018
Why it stopped: difficulties in recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unipolar DepressionStudies 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
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Courtet, MD PhD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02710279
- Sponsor's protocol ID
- 9615
- Other IDs
- 2015-A01308-41
- Acronym
- SADS-CS
- Status last verified
- Dec 2021
- First submitted
- 11 Mar 2016
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Response to Social Rejection in Suicidal Behavior
- ClinicalTrials.gov ID
- NCT02710279
- Acronym / sponsor ID
- SADS-CS / 9615
- Conditions
- Unipolar Depression
- Keywords
- Psychiatry, Depressive disorder, Suicide
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficulties in recruitment
- Enrolment
- 79 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 19 Feb 2016 (actual)
- Primary completion
- 15 Feb 2018 (actual)
- Study completion
- 15 Feb 2018 (actual)
- First posted
- 16 Mar 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.
Suicide is a major health problem that causes annually a million death worldwild. In the stress-vulnerability model, suicidal behavior (SB) results from the interaction between an individual's predisposition and stressful condition. We hypothesized that the sensitivity to social exclusion may represent a core component of the suicidal vulnerability Recent evidence also suggest that inflammatory mediators plays a critical role in SB. Furthermore, social stressors are particulary strong and specific triggers of inflammatory response.
To sum up, patients carrying a suicidal vulnerability are expected to present greater responses to social rejection in terms of inflammatory activity and psychological pain.
The aim of the study is to evaluate the psychological and inflammatory responses to a social stressor validated, the Trier Social Stress Test (TSST) . We will also investigate the moderating effect of childhood abuse, attachment, trait rejection sensitivity and social isolation.
In the second part of the study, we will also investigate the prospective association between inflammatory responses induces by laboratory paradigms of social rejection and the occurrence of social distress, suicidal ideation and psychological pain in response to social exclusion events in real life (using ecological momentary assessment).
Detailed description
Over one year, we will recruit 140 female outpatients suffering from a major depressive episode with (n=70) and without any history of suicide attempt (n=70) from a specialized clinic for mood disorders and SB.
First visit: clinical, biological and neuropsychological assessment Second visit: The TSST is a standardized laboratory psychosocial stress protocol that involves public speaking, role play, and mental arithmetic tasks in front of a panel of confederate judges. Blood samples will be obtained before the introduction to the TSST and immediately after and at + 30, + 60, + 90, and + 120 min. Self-ratings of emotional states, anxiety, anger and psychological pain will be completed at the same times.
Third visit: Participants will be instructed to carry a smartphone with them for one week, and to record at each alarm signal daily life events, negative emotions, psychological pain, suicidal ideas, and specific attributions to these events. Participants will be signalled five times a day during the period. Subjects will be contacted by telephone halfway through the assessment period to monitor and encourage compliance.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Depressive patients | Other | Behavioral: Trier Social Stress Test (TSST), Device: smartphoneDepressive patients with or without story of suicidal behavior will pass the TSST and will have a psychological assessment to complete with a questionnaire on their smartphone |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Non specifics
- Female
- Between 18 and 65 years
- Main diagnosis of unipolar major depressive episode (DSM-IV criteria)
- Having signed informed consent
Key exclusion criteria (8 listed)
- Inflammatory or intercurrent pathology
- Lifetime history of schizophrenia, or schizoaffective or bipolar disorder, according to DSM-IV criteria;
- Current diagnosis of substance abuse or dependence in the last year (excluding tobacco)
- Current organic mental disorder or mental retardation, or severe comorbid medical condition
- Participation in another clinical trial
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 |
|---|---|---|
| Trier Social Stress Test (TSST)For the TSST the participants are instructed to imagine having applied for their "dream job" and that they are now invited to a job interview. Three successive phases: (1) A preparation period (3 min), (2) a free speech: explain why you are the best candidate for the job (5 min), (3) a mental arithmetic complex task (5 min). The two tasks (task 2 and 3) are performed in front of a selection committee, three persons dressed in white lab coats, acting in a reserved manner and providing no facial or verbal feedback. Additionally, participants are told that they are video-taped and told that their performance will be evaluated. (in fact, there is no video-tape, just a false camera). After the TSST, patients have to answer to a questionnaire on their smartphone, 5 times a day during 7 days. | Behavioural | Depressive patients |
| smartphone | Device | Depressive patients |
Primary outcome
Psychological pain response to Trier Social Stress Test (TSST) assessed by visual analogic sale
Time frame: up to one week
comparaison of psychological pain response between group with personal history of suicid attempt and group without personal history of suicid attempt
4 secondary outcomes
Inflammatory response to TTST
Time frame: up to one week
Impact of loneliness and childhood abuse on inflammatory markers
Time frame: up to one week
impact of neuropschychological function on psychological pain
Time frame: up to one week
Social rejection assessed by likert scale in real life condition with a smartphone
Time frame: 7 days after the TSST
Results and safety
The study was stopped early (reason given: difficulties in recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
- Individual participant dataSharing planned: Undecided
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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.
Philippe Courtet, MD PhD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trier Social Stress Test (TSST) and smartphone in people with Unipolar Depression, 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 9 inclusion and 8 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 3 Aug 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: difficulties in recruitment). 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?
Psychological pain response to Trier Social Stress Test (TSST) assessed by visual analogic sale (time frame: up to one week). 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 3 Aug 2022; AzTrials last refreshed its copy on 29 Oct 2026.