Clinical trial NCT05686772: Prospective Multicenter Cohort Study Evaluating the Incidence and Risk Factors for Problem Gambling Among Young Adults With First-episode Psychosis
Official title: A Better Understanding of the Association Between Problem Gambling and Psychotic Disorders in Young Adults: a New Path Towards Recovery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gambling Disorder
Psychotic Disorders
Keywords: Gambling
Psychotic disorder
Schizophrenia
Cohort
Multicenter
Prospective
Observational
Incidence
Risk factors
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: Fonds de la Recherche en Santé du Québec
First posted: 2023-01-17
Enrollment: 520
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients meeting the inclusion/exclusion criteria admitted to 2 first-episode psychosis programs located in Quebec (Canada) during the study period (i.e., November 1st, 2019 - May 1st, 2023).

Brief summary: The aims of this propsective cohort study are to get a better understanding of the association between problem gambling and psychotic disorders among young adults with first-episode psychosis.

The main questions to be answered are:

1. What is the incidence of problem gambling in this population?
2. What are the predictors of problem gambling in this population?

To do so, putative predictors of problem gambling will be analyzed using Cox regression models:

* Sociodemographics (e.g., age, gender identity, ethnicity, level of education, employment);
* Psychiatric comorbidities (e.g., substance use disorders, cluster B personality disorders);
* Antipsychotic use (first/second-generation, third-generation \[aripiprazole, brexpiprazole, cariprazine\]);
* Prior gambling history.

Detailed description: All Cox regression models will be adjusted for site-effect. Further multivariable models will be constructed to examine the association between antipsychotic use (as continuous exposure) and incident PBG using the directed acyclic graphs approach to adjust for confounders.

Eligibility criteria: 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:

* Active/prior PBG at te time of admission;
* Loss to follow-up within first three months;
* DSM-5 diagnosis of psychotic disorder due to a medical condition;
* Severe intellectual disability.

Primary outcomes:
measure: Problem gambling
timeFrame: Outcome assessed at every 6-month time point, from patients admission until the first occurrence of the primary outcome, loss to follow-up, or May 1, 2023.
Secondary outcomes:
Other outcomes:
measure: Sensitivity analysis restricted to DSM-5 gambling disorder
timeFrame: Outcome assessed at every 6-month time point, from patients admission until the first occurrence of the primary outcome, loss to follow-up, or May 1, 2023.
Locations:
city: Montreal
country: Canada
facility: Montreal University Hospital Center
state: Quebec
city: Quebec
country: Canada
facility: Quebec Mental Health University Institute
Study officials:
References:
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.
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.
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.
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.
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.
citation: 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.