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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05686772
Other study ID # 2020-OJUR-286304
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 1, 2019
Est. completion date May 1, 2024

Study information

Verified date January 2023
Source Laval University
Contact Olivier Corbeil, PharmD, MSc
Phone 1-418-663-5000
Email olivier.corbeil.1@ulaval.ca
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this observational study is to get a better understanding of the association between problem gambling psychotic disorders among young adults with firs-episode psychosis. The main questions to be answered are: 1. What are the incidence and risk factors for problem gambling in this population? 2. How effective are the current treatments for problem gambling in adults with first-episode psychosis? To do so, comparisons will be made among the study cohort for various factors: - Use of dopamine partial agonists; - Psychiatric comorbidities; - Socioeconomic status; - Sex; - Gender; - Gambling history. The nature of the treatments for problem gambling offered and received by the subjects, as well as their effectiveness, will also be documented.


Recruitment information / eligibility

Status Recruiting
Enrollment 800
Est. completion date May 1, 2024
Est. primary completion date May 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria: - 18 to 35 years old; - Diagnosis of first-episode psychosis (i.e., DSM-5 diagnosis of schizophrenia spectrum and other psychotic disorders, as well as DSM-5 bipolar disorder with psychotic features). Exclusion Criteria: - DSM-5 diagnosis of psychotic disorder due to a medical condition; - Severe intellectual disability.

Study Design


Intervention

Drug:
Dopamine partial agonists
Use of antipsychotics (i.e., dopamine partial agonists vs dopamine antagonists)
Other:
Psychiatric comorbidities
Mainly substance use disorders and personality disorders
Sex
Biological sex at birth
Gender
Current gender identity
Socioeconomic status
Including main source of income, employment status, homelessness
Gambling history
History of gambling (i.e., recreational or problematic) prior to admission in the clinics

Locations

Country Name City State
Canada Montreal University Hospital Center Montreal Quebec
Canada Quebec Mental Health University Institute Quebec

Sponsors (2)

Lead Sponsor Collaborator
Laval University Fonds de recherche du Québec

Country where clinical trial is conducted

Canada, 

References & Publications (6)

Bergamini A, Turrina C, Bettini F, Toccagni A, Valsecchi P, Sacchetti E, Vita A. At-risk gambling in patients with severe mental illness: Prevalence and associated features. J Behav Addict. 2018 Jun 1;7(2):348-354. doi: 10.1556/2006.7.2018.47. Epub 2018 Jun 5. — View Citation

Corbeil O, Corbeil S, Dorval M, Carmichael PH, Giroux I, Jacques C, Demers MF, Roy MA. Problem Gambling Associated with Aripiprazole: A Nested Case-Control Study in a First-Episode Psychosis Program. CNS Drugs. 2021 Apr;35(4):461-468. doi: 10.1007/s40263-021-00801-4. Epub 2021 Mar 13. — View Citation

Corbeil O, Corbeil S, Giroux I, Jacques C, Dorval M, Demers MF, Roy MA. Problem Gambling Associated With Aripiprazole in First-Episode Psychosis Patients: A Series of 6 Case Reports. J Clin Psychopharmacol. 2020 Mar/Apr;40(2):191-194. doi: 10.1097/JCP.0000000000001177. — View Citation

Desai RA, Potenza MN. A cross-sectional study of problem and pathological gambling in patients with schizophrenia/schizoaffective disorder. J Clin Psychiatry. 2009 Sep;70(9):1250-7. doi: 10.4088/JCP.08m04359. Epub 2009 Jun 16. — View Citation

Haydock M, Cowlishaw S, Harvey C, Castle D. Prevalence and correlates of problem gambling in people with psychotic disorders. Compr Psychiatry. 2015 Apr;58:122-9. doi: 10.1016/j.comppsych.2015.01.003. Epub 2015 Jan 15. — View Citation

Lachance A, Corbeil O, Corbeil S, Chalifour G, Breault AS, Roy MA, Demers MF. Case Reports of Aripiprazole and Problematic Gambling in Schizophrenia: A Critical Review of the Evidence. J Clin Psychopharmacol. 2019 Jul/Aug;39(4):393-397. doi: 10.1097/JCP.0000000000001068. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Gambling disorder Diagnosis of gambling disorder according to DSM-5 criteria, established by the treating psychiatrist At baseline (i.e., at admission in the clinic)
Primary Gambling disorder Diagnosis of gambling disorder according to DSM-5 criteria, established by the treating psychiatrist At 6 months
Primary Gambling disorder Diagnosis of gambling disorder according to DSM-5 criteria, established by the treating psychiatrist At 12 months
Primary Gambling disorder Diagnosis of gambling disorder according to DSM-5 criteria, established by the treating psychiatrist At 18 months
Primary Gambling disorder Diagnosis of gambling disorder according to DSM-5 criteria, established by the treating psychiatrist At 24 months
Primary Gambling disorder Diagnosis of gambling disorder according to DSM-5 criteria, established by the treating psychiatrist At 30 months
Primary Gambling disorder Diagnosis of gambling disorder according to DSM-5 criteria, established by the treating psychiatrist At 36 months
Secondary Problem gambling Problem gambing according to a score of 8 and more on the Problem Gambling Severity Index, as questioned by the clinical case manager At baseline (i.e., at admission in the clinic)
Secondary Problem gambling Problem gambing according to a score of 8 and more on the Problem Gambling Severity Index, as questioned by the clinical case manager At 6 months
Secondary Problem gambling Problem gambing according to a score of 8 and more on the Problem Gambling Severity Index, as questioned by the clinical case manager At 12 months
Secondary Problem gambling Problem gambing according to a score of 8 and more on the Problem Gambling Severity Index, as questioned by the clinical case manager At 18 months
Secondary Problem gambling Problem gambing according to a score of 8 and more on the Problem Gambling Severity Index, as questioned by the clinical case manager At 24 months
Secondary Problem gambling Problem gambing according to a score of 8 and more on the Problem Gambling Severity Index, as questioned by the clinical case manager At 30 months
Secondary Problem gambling Problem gambing according to a score of 8 and more on the Problem Gambling Severity Index, as questioned by the clinical case manager At 36 months
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