search
Back to results

Voluntary Drug Poisoning by Psychoactive Molecules: Identify Cognitive Markers (IMG-COG)

Primary Purpose

Suicide, Drug Poisoning

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Two visits for evaluation
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Suicide

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

  • 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

Sites / Locations

  • University Hospital Toulouse

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A group using amnesic substances

A control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
March 7, 2018
Last Updated
March 27, 2018
Sponsor
University Hospital, Toulouse
search

1. Study Identification

Unique Protocol Identification Number
NCT03481192
Brief Title
Voluntary Drug Poisoning by Psychoactive Molecules: Identify Cognitive Markers
Acronym
IMG-COG
Official Title
Voluntary Drug Poisoning by Psychoactive Molecules: Identify Cognitive Markers Predictive of a Preserved Memory of Care in Psychiatric Emergencies
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 2, 2018 (Actual)
Primary Completion Date
January 2019 (Anticipated)
Study Completion Date
January 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide, Drug Poisoning

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
103 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A group using amnesic substances
Arm Type
Experimental
Arm Description
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.
Arm Title
A control group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Two visits for evaluation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evaluation of the episodic score recall of the first interview (T1) at T2
Description
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 Outcome Measure Information:
Title
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
Description
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
Title
Sensitivity score of each test for the episodic memory test
Description
Sensitivity score of each test
Time Frame
Just After/24-48h after the psychiatric interview
Title
Specificity score of each test for the episodic memory test
Description
Specificity score of each test
Time Frame
Just After/24-48h after the psychiatric interview

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juliette SALLES, MD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Voluntary Drug Poisoning by Psychoactive Molecules: Identify Cognitive Markers

We'll reach out to this number within 24 hrs