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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03202290
Other study ID # RC17_0165
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 24, 2018
Est. completion date August 2020

Study information

Verified date September 2018
Source Nantes University Hospital
Contact Marie GRALL BRONNEC, Pr
Phone +33240847620
Email marie.bronnec@chu-nantes.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The prevalence of people suffering from gambling disorder is relatively high, and the impact on this disorder the individual and those around him is considerable. The etiopathogenic model of gambling disorder is multifactorial, involving various risk and vulnerability factors, involved in the initiation and maintenance of the disorder. Among these factors, neurocognitive alterations associated with the disorder has recently aroused interest among researchers. In this study, the investigators propose to explore the neurocognitive impairments of patients suffering from gambling disorder compared to a control group, in order to identify alterations that could be the target of cognitive remediation programs. Gambling disorder provides a unique opportunity to study the specific neurocognitive impairments of the addictive process because it is not biased by the neurotoxic effect of substances as it is the case in substance use disorders.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date August 2020
Est. primary completion date August 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- For the patients :

Aged of more than 18, Suffering from gambling disorder(diagnosis according to DSM-5), Patient starting care in the Addictology and Psychiatry department of the Nantes University Hospital, Mastering the French language, Social Security Affiliates, Having given consent

- For the volunteers:

Aged of more than 18, Subject not suffering from gambling disorder, Mastering the French language, Social Security Affiliates Having given consent

Exclusion Criteria:

- For patients :

Having psychiatric and addictive disorders (present and not stabilized mood disorders, anxiety disorders and substance-use disorders except nicotine, lifetime psychotic syndrome, diagnosed by the MINI and after consultation with the clinician), Unstable endocrine disruptions or neurological disorders (such as head trauma, neurodegenerative diseases, unbalanced epilepsy, mental retardation, etc.), Taking a non-stabilized psychotropic treatment for at least 2 weeks Consumption of a psychoactive substance - other than nicotine - within the 12 hours preceding the assessment, Presenting a score on the HAD questionnaire = 11, Having benefited from a current or past RC program, Reporting to be pregnant or nursing, Current participation or in the past month in a pharmacological research protocol, Presenting difficulties for the reading or writing of the French language, Being under guardianship, Presenting disorders of higher functions

- For volunteers:

Suffering from past or current pathological gambling (DSM-5 diagnosis), Having psychiatric and addictive disorders (mood disorders, anxiety disorders and disorders linked to the use of non-nicotine substance present and not stabilized, life-long psychotic syndrome, diagnosed by the MINI), endocrine or neurological disorders (Cranial trauma, neurodegenerative diseases, unbalanced epilepsy, mental retardation, etc.), Taking a non-stabilized psychotropic treatment for at least 2 weeks, Declaring to have consumed a psychoactive substance - other than nicotine - within the 12 hours preceding the assessment, Presenting a score on the HAD questionnaire = 11, Having benefited from an assumption in current or past RC program, Reporting to be pregnant or nursing, Currently participating or in the past month to a pharmacological research protocol, Presenting difficulties for the reading or writing of the French language, Being under guardianship, Presenting disorders of cognitive functions

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Cognitive and clinical assessment
The content of the assessment will be the same for all subjects and will consist of a cognitive assessment (neurocognition, social cognition, metacognition, emotional reactivity) and a clinical assessment (impulsivity, personality, psychriatric and addictive comorbidities)

Locations

Country Name City State
France CHU de Nantes Nantes

Sponsors (1)

Lead Sponsor Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean difference of the scores obtained at the various neurocognitive tests between the group of disordered gamblers and the group of healthy controls 2.5 hours
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