SuicideIMG-COGNCT03481192
Voluntary Drug Poisoning by Psychoactive Molecules: Identify Cognitive Markers
A study testing Two visits for evaluation in people with Suicide and Drug Poisoning, run by University Hospital, Toulouse at 1 site in France.
Trial summary
To identify in patients admitted for Voluntary drug poisoning (IMV) by psychoactive substances, T1 predictors of T2 recall of psychiatric interview and care project. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Suicide, Drug Poisoning
- What is being tested?
- Two visits for evaluation
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jan 2018to Jan 2019
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Group amnesic substances :
- Age from 18 to 65 years
- Admitted to emergencies for IMV by benzodiazepines
- Supported at Toulouse University Hospital (hospitalization, outpatient)
- Group control :
- Age from 18 to 65 years
- Admitted to emergencies for IMV by non-depressive substances of the central nervous system
- Supported at Toulouse University Hospital (hospitalization, outpatient)
Who cannot join
- Cognitive Disorder Due to an Organic Disorder Neuro Degenerative Disease, Korsakoff Syndrome) or Mental Retardation Diagnosed
- Patient under guardianship
- Not speaking and / or not reading French
- Neurodegenerative disease diagnosed
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Voluntary Drug Poisoning by Psychoactive Molecules: Identify Cognitive Markers Predictive of a Preserved Memory of Care in Psychiatric Emergencies
To identify in patients admitted for Voluntary drug poisoning (IMV) by psychoactive substances, T1 predictors of T2 recall of psychiatric interview and care project.
Read the detailed description
The methodology will compare the episodic memory results of patients admitted for IMV who have exclusively ingested amnesic substances to a subject control group that has made IMV with non-amnesic substances such as paracetamol. The purpose of this comparison is to ensure that memory problems are not related to the context of the suicidal crisis.
The second step will be able to relate the memory score of the predictor variables. To achieve this, it will perform a multivariate linear regression in each group in order to confirm the results of the pilot study and to be able to regress in the control group which was not possible in the pilot study because of the lack of effective.
Finally, this study will try to establish, using Receiver Operating Characteristic (ROC) curves, thresholds for cognitive scores and begin to develop a tool for clinical practice.
- Conditions
- Suicide, Drug Poisoning
- Being tested
- Two visits for evaluation
- Medical subject headings
- Suicide, Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two visits for evaluationBehavioural
Visit 1:The first evaluation (E1) of cognitive functions will take place directly following the psychiatric interview (T1), in order to better reflect the cognitive abilities at the time of the proposal of the care project.
This will include the Memory Functioning Questionnaire (MFQ), the five words of DUBOIS, the TMT-A and B, the WAIS code test, and the BADDELEY door test. An intercurrent type ringing event of the phone will take place during this evaluation.
Visit 2: At 24h-48h of the psychiatric evaluation (T2), a second evaluation (E2) will take place.
An episodic memory score will be determined by asking the patient to recall,as precisely as possible the evaluation E1. At first the reminder will be free,the data can be completed, if necessary, with an indication, a recognition.
| Study group | Role | What they receive |
|---|---|---|
| A group using amnesic substances | Experimental | A group of patients admitted for IMV exclusively using amnesic substances. Benzodiazepines, benzodiazepines, tricyclic antidepressants, neuroleptics, antihistamines, other atropine substances, anti-epileptics and opiates.
Two visits for evaluation, the first one for the first evaluation of cognitive functions directly following the psychiatric interview, and the second one at 24h-48h of the psychiatric evaluation (T2), a second evaluation (E2) will take place. Receives: Behavioral: Two visits for evaluation |
| A control group | Active comparator | A control group that ingested exclusively non-amnesic substances among them most frequently ingested in this context, ie the following classes: level 1 analgesics, antibiotics, serotonergic and noradrenergic antidepressants, oral antidiabetic, thyroid hormones, anti oral coagulant.
Two visits for evaluation, the first one for the first evaluation of cognitive functions directly following the psychiatric interview, and the second one at 24h-48h of the psychiatric evaluation (T2), a second evaluation (E2) will take place. Receives: Behavioral: Two visits for evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the episodic score recall of the first interview (T1) at T2
This score is based on the episodic scale. The episodic score is a reflection of the patient's memory of the emergency psychiatric assessment. In this study, this score will be used as a variable independent of the multivariate linear regression, the objective of the study being to identify the variables significantly related to this score.
The total episodicity score is calculated by adding the episodic scores of several events. A continuous score is obtained and between 0 and 38.
Measured: Just After/24-48h after the psychiatric interview
Secondary outcomes (3)
Comparison of cognitive scores between the amnesic substances group and the control group using the The Memory Functioning Questionnaire (MFQ) abridged version of tthe Memory Functioning Questionnaire
The control group is a group of subject having made an IMV with non-amnesic substances such as paracetamol.
Measured: Just After/24-48h after the psychiatric interview
Sensitivity score of each test for the episodic memory test
Sensitivity score of each test
Measured: Just After/24-48h after the psychiatric interview
Specificity score of each test for the episodic memory test
Specificity score of each test
Measured: Just After/24-48h after the psychiatric interview
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start2 Jan 2018
- Primary completionJan 2019 (estimated)
- Study completionJan 2019 (estimated)
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- To groups of patients : A group of patients admitted for IMV exclusively using amnesic substances. A control group admitted for IMV and ingested exclusively non-amnesic Two visits, the first one for the first evaluation of cognitive functions directly following the psychiatric interview (E1), and the second one at 24h-48h after the psychiatric evaluation (E2)
- Masking
- None (open label)
- Enrolment
- 103 participants (estimated)
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, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03481192
- Sponsor's protocol ID
- RC31/17/0160
- Other IDs
- 2017-A01581-52
- Acronym
- IMG-COG
- Status last verified
- Mar 2018
- First submitted
- 7 Mar 2018
- Last updated
- 29 Mar 2018
- 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 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Voluntary Drug Poisoning by Psychoactive Molecules: Identify Cognitive Markers Predictive of a Preserved Memory of Care in Psychiatric Emergencies
- ClinicalTrials.gov ID
- NCT03481192
- Acronym / sponsor ID
- IMG-COG / RC31/17/0160
- Conditions
- Suicide, Drug Poisoning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 103 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 2 Jan 2018 (actual)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 29 Mar 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.
To identify in patients admitted for Voluntary drug poisoning (IMV) by psychoactive substances, T1 predictors of T2 recall of psychiatric interview and care project.
Detailed description
The methodology will compare the episodic memory results of patients admitted for IMV who have exclusively ingested amnesic substances to a subject control group that has made IMV with non-amnesic substances such as paracetamol. The purpose of this comparison is to ensure that memory problems are not related to the context of the suicidal crisis.
The second step will be able to relate the memory score of the predictor variables. To achieve this, it will perform a multivariate linear regression in each group in order to confirm the results of the pilot study and to be able to regress in the control group which was not possible in the pilot study because of the lack of effective.
Finally, this study will try to establish, using Receiver Operating Characteristic (ROC) curves, thresholds for cognitive scores and begin to develop a tool for clinical practice.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- To groups of patients : A group of patients admitted for IMV exclusively using amnesic substances. A control group admitted for IMV and ingested exclusively non-amnesic Two visits, the first one for the first evaluation of cognitive functions directly following the psychiatric interview (E1), and the second one at 24h-48h after the psychiatric evaluation (E2)
| Arm | Type | Receives |
|---|---|---|
| A group using amnesic substances | Experimental | Behavioral: Two visits for evaluationA group of patients admitted for IMV exclusively using amnesic substances. Benzodiazepines, benzodiazepines, tricyclic antidepressants, neuroleptics, antihistamines, other atropine substances, anti-epileptics and opiates. Two visits for evaluation, the first one for the first evaluation of cognitive functions directly following the psychiatric interview, and the second one at 24h-48h of the psychiatric evaluation (T2), a second evaluation (E2) will take place. |
| A control group | Active comparator | Behavioral: Two visits for evaluationA control group that ingested exclusively non-amnesic substances among them most frequently ingested in this context, ie the following classes: level 1 analgesics, antibiotics, serotonergic and noradrenergic antidepressants, oral antidiabetic, thyroid hormones, anti oral coagulant. Two visits for evaluation, the first one for the first evaluation of cognitive functions directly following the psychiatric interview, and the second one at 24h-48h of the psychiatric evaluation (T2), a second evaluation (E2) will take place. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age from 18 to 65 years
- Admitted to emergencies for IMV by benzodiazepines
- Supported at Toulouse University Hospital (hospitalization, outpatient)
- Age from 18 to 65 years
- Admitted to emergencies for IMV by non-depressive substances of the central nervous system
Key exclusion criteria (4 listed)
- Cognitive Disorder Due to an Organic Disorder Neuro Degenerative Disease, Korsakoff Syndrome) or Mental Retardation Diagnosed
- Patient under guardianship
- Not speaking and / or not reading French
- Neurodegenerative disease diagnosed
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 |
|---|---|---|
| Two visits for evaluationVisit 1:The first evaluation (E1) of cognitive functions will take place directly following the psychiatric interview (T1), in order to better reflect the cognitive abilities at the time of the proposal of the care project. This will include the Memory Functioning Questionnaire (MFQ), the five words of DUBOIS, the TMT-A and B, the WAIS code test, and the BADDELEY door test. An intercurrent type ringing event of the phone will take place during this evaluation. Visit 2: At 24h-48h of the psychiatric evaluation (T2), a second evaluation (E2) will take place. An episodic memory score will be determined by asking the patient to recall,as precisely as possible the evaluation E1. At first the reminder will be free,the data can be completed, if necessary, with an indication, a recognition. | Behavioural | A control group, A group using amnesic substances |
Primary outcome
Evaluation of the episodic score recall of the first interview (T1) at T2
Time frame: Just After/24-48h after the psychiatric interview
This score is based on the episodic scale. The episodic score is a reflection of the patient's memory of the emergency psychiatric assessment. In this study, this score will be used as a variable independent of the multivariate linear regression, the objective of the study being to identify the variables significantly related to this score. The total episodicity score is calculated by adding the episodic scores of several events. A continuous score is obtained and between 0 and 38.
3 secondary outcomes
Comparison of cognitive scores between the amnesic substances group and the control group using the The Memory Functioning Questionnaire (MFQ) abridged version of tthe Memory Functioning Questionnaire
Time frame: Just After/24-48h after the psychiatric interview
Sensitivity score of each test for the episodic memory test
Time frame: Just After/24-48h after the psychiatric interview
Specificity score of each test for the episodic memory test
Time frame: Just After/24-48h after the psychiatric interview
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 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.
Juliette SALLES, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Two visits for evaluation in people with Suicide and Drug Poisoning, 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 8 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 29 Mar 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?
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?
Evaluation of the episodic score recall of the first interview (T1) at T2 (time frame: Just After/24-48h after the psychiatric interview). 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 29 Mar 2018.