SuicideAQUARIUMNCT03674580
Impairment of the Cognitive Flow in the Development of a Depressive Disorder and Suicidal Ideas
An observational study of Suicide, run by Hôpital NOVO at 1 site in France.
Trial summary
The study consists in estimating the mental load (cognitive saturation) and the production of driving cognition to suicidal patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicide
- What is being tested?
- Follow-up of the suicidal patients
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 67 participants
- Where
- 1 siteFrance
- Study dates
- May 2015to Sep 2015
- 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: Suicidal patients followed at the Hospital Rene Dubos
Who may be able to join
- Patients followed within the framework of an ambulatory follow-up post-emergencies(post-urgent matters).
- Knowledge of the French language
- patient who have signed of the form of consent,
- patient presenting one anxio-depressive disorder(confusion) with or without suicidal episode.
Who cannot join
- Not compatible health with the signing of the protocol,
- the not knowledge of the French language,
- patient who have refused the protocol.
Trial locations and contacts
1 site in 1 country.
About this study
The study consists in estimating the mental load (cognitive saturation) and the production of driving cognition to suicidal patients.
Read the detailed description
The study consists in testing two big general hypotheses:
- In the first place, that suicidals presents a mental load (cognitive saturation) and an activity pain behaviour of their space of the thought by extremely painful peripheral cognitive movements (impression that the brain is saturated of thoughts, turbulences, internal movements)
- Secondly, that suicidals produces a surplus of representations of action, such takes out that their vision of the world is saturated of a not integrable kinaesthetic imaging by the subject.
- Conditions
- Suicide
- Being tested
- Follow-up of the suicidal patients
- Keywords
- suicidal patients;psychiatry
- Medical subject headings
- Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow-up of the suicidal patientsBehavioural
No intervention. Follow-up of the suicidal patients
| Study group | Role | What they receive |
|---|---|---|
| Suicidal patients | No intervention. Follow-up of the suicidal patients Receives: Behavioral: Follow-up of the suicidal patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mental load (calm or turbulence of the spirit) - test of the aquarium
To assess the calm or the turbulence of the spirit of the participant, the investigator will make him take the test of the aquarium. The participant will perform an exercise to assess the load and movement of his thoughts. The participant must imagine that the aquarium reflects the content of his mind. The fish are the thoughts and the waves represent the turbulences and movements of all these thoughts. Some subjects, for example, play about with the size of the fish ("it is only a single large fish, but it takes over my entire head"), the shape of the fish ("these fish are pointed because they are bad"), scrawl (the participant scrawled on the aquarium to say that his head was overrun), the projection of feelings ("those fish there are sad") or made digressive but interesting comments ("the wavy lines carry away the fish...").
Measured: 5 days
Secondary outcomes (2)
Moral pain - Analog Visual Scale Battery
In order to evaluate the participant's moral pain, the investigator proposes to answer the questions of a test titled Analog Visual Scale Battery. It is in the form of a horizontal bar with left a peaceful state (mental pain not strong at all...) and conversely, on the right are the opposite feelings corresponding to a moral pain (very strong mental pain). The participant is asked to check on the bar the level that most seems to reflect his feelings or impressions related to his moral pain.
Measured: 5 days
Suicidal thoughts - Analog Visual Scale Battery
In order to evaluate the participant's situation, the investigator proposes to answer the questions of a test titled Analog Visual Scale Battery. It is in the form of a horizontal bar with left a peaceful state (example: calm thoughts, slight suicidal ideation ...) and conversely, on the right are the opposite feelings corresponding to a tormented state (example: many thoughts, suicidal ideation ...). The participant is asked to check on the bar the level that most seems to reflect his feelings or impressions related to his suicidal ideation.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2018
- Study startMay 2015
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SuicideStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital NOVO
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- BAUDOIN Thierry, PH, Principal investigator, Rene Dubos Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03674580
- Sponsor's protocol ID
- CHRD1515
- Acronym
- AQUARIUM
- Status last verified
- Sep 2018
- First submitted
- 13 Sep 2016
- Last updated
- 17 Sep 2018
- 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 17 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impairment of the Cognitive Flow in the Development of a Depressive Disorder and Suicidal Ideas
- ClinicalTrials.gov ID
- NCT03674580
- Acronym / sponsor ID
- AQUARIUM / CHRD1515
- Conditions
- Suicide
- Keywords
- suicidal patients;psychiatry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Hôpital NOVOUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 17 Sep 2018 (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.
The study consists in estimating the mental load (cognitive saturation) and the production of driving cognition to suicidal patients.
Detailed description
The study consists in testing two big general hypotheses:
- In the first place, that suicidals presents a mental load (cognitive saturation) and an activity pain behaviour of their space of the thought by extremely painful peripheral cognitive movements (impression that the brain is saturated of thoughts, turbulences, internal movements)
- Secondly, that suicidals produces a surplus of representations of action, such takes out that their vision of the world is saturated of a not integrable kinaesthetic imaging by the subject.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suicidal patients | – | Behavioral: Follow-up of the suicidal patientsNo intervention. Follow-up of the suicidal patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Suicidal patients followed at the Hospital Rene Dubos
Key inclusion criteria (4 listed)
- Patients followed within the framework of an ambulatory follow-up post-emergencies(post-urgent matters).
- Knowledge of the French language
- patient who have signed of the form of consent,
- patient presenting one anxio-depressive disorder(confusion) with or without suicidal episode.
Key exclusion criteria (3 listed)
- Not compatible health with the signing of the protocol,
- the not knowledge of the French language,
- patient who have refused the protocol.
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 |
|---|---|---|
| Follow-up of the suicidal patientsNo intervention. Follow-up of the suicidal patients | Behavioural | Suicidal patients |
Primary outcome
Mental load (calm or turbulence of the spirit) - test of the aquarium
Time frame: 5 days
To assess the calm or the turbulence of the spirit of the participant, the investigator will make him take the test of the aquarium. The participant will perform an exercise to assess the load and movement of his thoughts. The participant must imagine that the aquarium reflects the content of his mind. The fish are the thoughts and the waves represent the turbulences and movements of all these thoughts. Some subjects, for example, play about with the size of the fish ("it is only a single large fish, but it takes over my entire head"), the shape of the fish ("these fish are pointed because they are bad"), scrawl (the participant scrawled on the aquarium to say that his head was overrun), the projection of feelings ("those fish there are sad") or made digressive but interesting comments ("the wavy lines carry away the fish...").
2 secondary outcomes
Moral pain - Analog Visual Scale Battery
Time frame: 5 days
Suicidal thoughts - Analog Visual Scale Battery
Time frame: 5 days
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 17 Sep 2018.
- 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.
BAUDOIN Thierry, PH principal investigator
Rene Dubos Hospital
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, run by Hôpital NOVO 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 4 inclusion and 3 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 17 Sep 2018. 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?
Mental load (calm or turbulence of the spirit) - test of the aquarium (time frame: 5 days). 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 17 Sep 2018.