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

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.

Study Overview

• Status: Unknown
• Conditions: Suicide; Drug Poisoning
• Intervention / Treatment: Behavioral: Two visits for evaluation

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 Type: Interventional
• Enrollment (Anticipated): 103
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Toulouse, France, 31059
    • University Hospital Toulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Just After/24-48h after the psychiatric interview

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Just After/24-48h after the psychiatric interview
Sensitivity score of each test for the episodic memory test	Sensitivity score of each test	Just After/24-48h after the psychiatric interview
Specificity score of each test for the episodic memory test	Specificity score of each test	Just After/24-48h after the psychiatric interview

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 2, 2018
• Primary Completion (ANTICIPATED): January 1, 2019
• Study Completion (ANTICIPATED): January 1, 2019

Study Registration Dates

• First Submitted: March 7, 2018
• First Submitted That Met QC Criteria: March 27, 2018
• First Posted (ACTUAL): March 29, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 29, 2018
• Last Update Submitted That Met QC Criteria: March 27, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Chemically-Induced Disorders; Self-Injurious Behavior; Poisoning; Suicide; Drug-Related Side Effects and Adverse Reactions
• Other Study ID Numbers: RC31/17/0160; 2017-A01581-52 (OTHER: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No