Suicide, AttemptedISANCT03230448
Study of the Links Between Suicidal Intentionality and Acute Alcoholism
An observational study of Suicide, Attempted, run by University Hospital, Toulouse at 1 site in France.
Trial summary
There is a strong link between the alcohol consumption and the suicidal risk. Indeed there is an increase of the risk of suicide in case of chronic or acute alcohol consumption. However why the alcohol consumption increase the suicidal risk is unknown. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicide, Attempted
- What is being tested?
- questionnaire
- How many people
- 110 participants
- Where
- 1 siteFrance
- Study dates
- 29 May 2017to 31 Jul 2017
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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
Study population: people hospitalized in the emergency department after a suicide attempt by voluntary drug intoxication
Who may be able to join
- patient hospitalized in emergency department for a suicide attempt by voluntary drug intoxication
- speaking and understanding french
Who cannot join
- Patient who has used other psychoactive substances (attested by toxicological analyzes and / or interrogation)
- Known neurodegenerative pathology
Trial locations and contacts
1 site in 1 country.
About this study
There is a strong link between the alcohol consumption and the suicidal risk. Indeed there is an increase of the risk of suicide in case of chronic or acute alcohol consumption. However why the alcohol consumption increase the suicidal risk is unknown.
The hypothesis of this study is that the alcohol consumption induced disinhibition and facilitates the suicide attempt without premeditation
Read the detailed description
People hospitalized after a suicide attempt will answer to two questionnaires about the suicide intentionality and the acute alcohol consumption.
There is 2 arms:
people doing suicide attempt and with positive level of alcohol (up to 0.1g.L) people doing suicide attempt and with negative level of alcohol
110 patients will be included in this study so 55 in each arm.
- Conditions
- Suicide, Attempted
- Being tested
- questionnaire
- Keywords
- Acute alcoholism
- Medical subject headings
- Suicide, Attempted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireOther
after the inclusion patient will answer to a questionnaire about the suicidal intentionality and a second about the alcool consumption
| Study group | Role | What they receive |
|---|---|---|
| positive alcoholism | positive acute alcoholism had questionnaire about suicidal intentionality Receives: Other: questionnaire | |
| negative alcoholism | negative acute alcoholism had questionnaire about suicidal intentionality Receives: Other: questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
compare the score of suicidal intentionality in patient presenting a positive or a negative alcohol level and doing suicide attempt
patient will complete the PIERCE questionnaire about the suicidal intentionality
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2017
- Study start29 May 2017
- Primary completion31 Jul 2017
- Study completion31 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicide, AttemptedStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juliette SALLES, MD, Principal investigator, University Hospital of Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03230448
- Sponsor's protocol ID
- RC31/17-0074
- Other IDs
- 2017-A00641-52
- Acronym
- ISA
- Status last verified
- Aug 2017
- First submitted
- 24 Jul 2017
- Last updated
- 31 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Links Between Suicidal Intentionality and Acute Alcoholism
- ClinicalTrials.gov ID
- NCT03230448
- Acronym / sponsor ID
- ISA / RC31/17-0074
- Conditions
- Suicide, Attempted
- Keywords
- Acute alcoholism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 29 May 2017 (actual)
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 26 Jul 2017 (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.
There is a strong link between the alcohol consumption and the suicidal risk. Indeed there is an increase of the risk of suicide in case of chronic or acute alcohol consumption. However why the alcohol consumption increase the suicidal risk is unknown.
The hypothesis of this study is that the alcohol consumption induced disinhibition and facilitates the suicide attempt without premeditation
Detailed description
People hospitalized after a suicide attempt will answer to two questionnaires about the suicide intentionality and the acute alcohol consumption.
There is 2 arms:
people doing suicide attempt and with positive level of alcohol (up to 0.1g.L) people doing suicide attempt and with negative level of alcohol
110 patients will be included in this study so 55 in each arm.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| positive alcoholism | – | Other: questionnairepositive acute alcoholism had questionnaire about suicidal intentionality |
| negative alcoholism | – | Other: questionnairenegative acute alcoholism had questionnaire about suicidal intentionality |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- people hospitalized in the emergency department after a suicide attempt by voluntary drug intoxication
Key inclusion criteria (2 listed)
- patient hospitalized in emergency department for a suicide attempt by voluntary drug intoxication
- speaking and understanding french
Key exclusion criteria (2 listed)
- Patient who has used other psychoactive substances (attested by toxicological analyzes and / or interrogation)
- Known neurodegenerative pathology
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 |
|---|---|---|
| questionnaireafter the inclusion patient will answer to a questionnaire about the suicidal intentionality and a second about the alcool consumption | Other | negative alcoholism, positive alcoholism |
Primary outcome
compare the score of suicidal intentionality in patient presenting a positive or a negative alcohol level and doing suicide attempt
Time frame: 15 minutes
patient will complete the PIERCE questionnaire about the suicidal intentionality
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 31 Aug 2017.
- Individual participant dataSharing planned: No
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Suicide
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.
Juliette SALLES, MD principal investigator
University Hospital of Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Suicide, Attempted, run by University Hospital, Toulouse 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 2 inclusion and 2 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 31 Aug 2017. 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?
compare the score of suicidal intentionality in patient presenting a positive or a negative alcohol level and doing suicide attempt (time frame: 15 minutes). 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 31 Aug 2017.