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BANCO Study: Behavioral Addictions and Related NeuroCOgnitive Aspects: A Monocentric, Prospective, Controlled, Open-label Study of a Sample of Patients With Gambling Disorder (BANCO)

Primary Purpose

Gambling Disorder

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Cognitive and clinical assessment

About this trial

This is an interventional other trial for Gambling Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

CHU de NantesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Gambling disorder

Controls

Arm Description

patients suffering from gambling disorder

healthy controls

Outcomes

Primary Outcome Measures

Mean difference of the scores obtained at the various neurocognitive tests between the group of disordered gamblers and the group of healthy controls

Secondary Outcome Measures

Full Information

NCT ID

NCT03202290

First Posted

June 27, 2017

Last Updated

September 11, 2018

Sponsor

Nantes University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03202290

Brief Title

BANCO Study: Behavioral Addictions and Related NeuroCOgnitive Aspects: A Monocentric, Prospective, Controlled, Open-label Study of a Sample of Patients With Gambling Disorder

Acronym

BANCO

Official Title

BANCO Study: Behavioral Addictions and Related NeuroCOgnitive Aspects: A Monocentric, Prospective, Controlled, Open-label Study of a Sample of Patients With Gambling Disorder

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Unknown status

Study Start Date

August 24, 2018 (Actual)

Primary Completion Date

August 2020 (Anticipated)

Study Completion Date

August 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Nantes University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

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

Gambling Disorder

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Gambling disorder

Arm Type

Other

Arm Description

patients suffering from gambling disorder

Arm Title

Controls

Arm Type

Other

Arm Description

healthy controls

Intervention Type

Behavioral

Intervention Name(s)

Cognitive and clinical assessment

Intervention Description

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)

Primary Outcome Measure Information:

Title

Mean difference of the scores obtained at the various neurocognitive tests between the group of disordered gamblers and the group of healthy controls

Time Frame

2.5 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Marie GRALL BRONNEC, Pr

Phone

+33240847620

marie.bronnec@chu-nantes.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marie GRALL BRONNEC, Pr

Organizational Affiliation

Nantes University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU de Nantes

City

Nantes

ZIP/Postal Code

44093

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marie GRALL BRONNEC, Pr

marie.bronnec@chu-nantes.fr

First Name & Middle Initial & Last Name & Degree

Marie GRALL BRONNEC, Pr

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

34321880

Citation

Hurel E, Grall-Bronnec M, Thiabaud E, Saillard A, Hardouin JB, Challet-Bouju G. A Case-Control Study on Behavioral Addictions and Neurocognition: Description of the BANCO and BANCO2 Protocols. Neuropsychiatr Dis Treat. 2021 Jul 20;17:2369-2386. doi: 10.2147/NDT.S292490. eCollection 2021.

Results Reference

derived

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BANCO Study: Behavioral Addictions and Related NeuroCOgnitive Aspects: A Monocentric, Prospective, Controlled, Open-label Study of a Sample of Patients With Gambling Disorder

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