Voluntary Drug Poisoning by Psychoactive Molecules: Identify Cognitive Markers

Suicide Clinical Trial

— IMG-COG  

Official title:

Voluntary Drug Poisoning by Psychoactive Molecules: Identify Cognitive Markers Predictive of a Preserved Memory of Care in Psychiatric Emergencies

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03481192
• Other study ID #: RC31/17/0160
• Secondary ID: 2017-A01581-52
• Status: Active, not recruiting
• Phase: N/A
• First received: March 7, 2018
• Last updated: March 27, 2018
• Start date: January 2, 2018
• Est. completion date: January 2019

Study information

• Verified date: March 2018
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 103
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Drug Poisoning
• Drug-Related Side Effects and Adverse Reactions
• Poisoning
• Suicide

Intervention

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.

Locations

Country	Name	City	State
France	University Hospital Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Sensitivity score of each test for the episodic memory test	Sensitivity score of each test	Just After/24-48h after the psychiatric interview
Secondary	Specificity score of each test for the episodic memory test	Specificity score of each test	Just After/24-48h after the psychiatric interview