ClinicalTrials.gg
Status unknownNCT03481192IMG-COGUpdated Mar 29, 2018

Voluntary Drug Poisoning by Psychoactive Molecules: Identify Cognitive Markers

An interventional study of Two visits for evaluation in Suicide and Drug Poisoning, sponsored by University Hospital, Toulouse. Status unknown at 1 site in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-03-29.

Primary conditionSuicide(the registry's first term)UnverifiedIs this wrong?Suicide is a broad heading, used only when no more specific condition is named. No better condition is named, so the registry's term is kept.

Sponsored by University Hospital, Toulouse · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Mar 2018), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
103
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Suicide
  • Drug Poisoning

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03

In context

Suicide Unverified

607 studies on the registry are indexed under Suicide; 162 are open to participants now.

This study's planned enrollment of 103 is close to the median of 104 across 490 interventional studies indexed under Suicide.

Browse Suicide studies →

Lead sponsor

University Hospital, Toulouse is the lead sponsor of 807 studies on the registry; 209 are open to participants now.

Compared within Suicide, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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)

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
103 participants (estimated)

Study arms

  • Experimental
    A group using amnesic substances

    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.

    Behavioral: Two visits for evaluation

  • Active comparator
    A control group

    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.

    Behavioral: Two visits for evaluation

Interventions

  • BehavioralTwo visits for evaluation

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Just After/24-48h after the psychiatric interview

Secondary outcomes

  1. 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.

    Time frame: Just After/24-48h after the psychiatric interview

  2. Sensitivity score of each test for the episodic memory test

    Sensitivity score of each test

    Time frame: Just After/24-48h after the psychiatric interview

  3. Specificity score of each test for the episodic memory test

    Specificity score of each test

    Time frame: Just After/24-48h after the psychiatric interview

07

Study locations

1 site
  • University Hospital Toulouse
    Toulouse, 31059, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2018 (actual). Primary completion is estimated for Jan 2019, 12 months after the start.

Of 308 non-industry interventional studies with no phase under Suicide, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 54. This study's planned 12 months is below that.

Counting every sponsor, half of 319 studies reached it within 30 months; a quarter within 15 and three quarters within 53.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 7, 2018
First posted
Mar 29, 2018
StartActual
Jan 2, 2018
Primary completionEst.
Jan 2019
CompletionEst.
Jan 2019
Last update
Mar 29, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 29, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03481192
Responsible party
Sponsor
First posted
Mar 29, 2018
Start date
Jan 2, 2018
Primary completion
Jan 2019 (estimated)
Completion
Jan 2019 (estimated)
Last update
Mar 29, 2018

Study contacts

Juliette SALLES, MD
principal investigator · University Hospital, Toulouse

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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