Voluntary Drug Poisoning by Psychoactive Molecules: Identify Cognitive Markers

NCT ID: NCT03481192

Last Updated: 2018-03-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 103 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-02
• Study Completion Date: 2019-01-31

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.

Conditions

Suicide; Drug Poisoning

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Two visits for evaluation

Intervention Type: BEHAVIORAL

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.

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.

Group Type: ACTIVE_COMPARATOR

Two visits for evaluation

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Juliette SALLES, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

University Hospital Toulouse

Toulouse, , France

Countries

France

Other Identifiers

2017-A01581-52

Identifier Type: OTHER

Identifier Source: secondary_id

RC31/17/0160

Identifier Type: -

Identifier Source: org_study_id