NCT05686772

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:

  • 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
520

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2019

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2019

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

December 29, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 17, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

May 28, 2025

Status Verified

May 1, 2025

Enrollment Period

3.5 years

First QC Date

December 29, 2022

Last Update Submit

May 21, 2025

Conditions

Keywords

GamblingPsychotic disorderSchizophreniaCohortMulticenterProspectiveObservationalIncidenceRisk factors

Outcome Measures

Primary Outcomes (1)

  • Problem gambling

    i) Diagnosis of gambling disorder according to DSM-5 criteria, established by the treating psychiatrist, and/or; ii) Problem gambling according to a score of 8 and more on the Problem Gambling Severity Index, as questioned by the clinical case manager and/or treating psychiatrist

    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.

Other Outcomes (1)

  • Sensitivity analysis restricted to DSM-5 gambling disorder

    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.

Study Arms (1)

First-episode psychosis patients

All patients aged 18-35 years with a diagnosis of FEP admitted at two FEP programs in the province of Quebec, Canada.

Drug: Antipsychotic useOther: Psychiatric comorbiditiesOther: Sociodemographics/socioeconomic statusOther: Gambling historyOther: Clinical variables

Interventions

Use of first/second generation antipsychotics, use of third-generation antipsychotics, use of aripiprazole specifically

First-episode psychosis patients

Substance use disorders, cluster B personality disorders, anxiety disorder, major depressive disorder, attention-deficit/hyperactivity disorder, tobacco smoking

First-episode psychosis patients

Age, gender identity, ethnicity, highest educational attainment, employment, at school, homelessness, in a relationship

First-episode psychosis patients

Non-problematic gambling at the time of admission and/or previous 12 months

First-episode psychosis patients

Main psychiatric diagnosis, history of psychiatric hospitalizations, severity of illness (CGI-S), functioning (SOFAS), concomitant psychotropic medications use

First-episode psychosis patients

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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).

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Montreal University Hospital Center

Montreal, Quebec, H2X 3E4, Canada

Location

Quebec Mental Health University Institute

Québec, Quebec, G1J 2G3, Canada

Location

Related Publications (7)

  • 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.

    PMID: 33713298BACKGROUND
  • 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.

    PMID: 32134855BACKGROUND
  • 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.

    PMID: 31206391BACKGROUND
  • 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.

    PMID: 19538900BACKGROUND
  • 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.

    PMID: 25684263BACKGROUND
  • 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.

    PMID: 29865864BACKGROUND
  • Corbeil O, Soulard M, Huot-Lavoie M, Bechard L, Fournier E, Brodeur S, Essiambre AM, Desmeules C, Theriault C, Abdel-Baki A, Jacques C, Giroux I, Dorval M, Roy MA, Demers MF. Problem gambling among people with first-episode psychosis: protocol for a prospective multicenter cohort study. BMC Psychiatry. 2023 Apr 25;23(1):287. doi: 10.1186/s12888-023-04741-9.

MeSH Terms

Conditions

GamblingPsychotic DisordersSchizophrenia

Interventions

Social Class

Condition Hierarchy (Ancestors)

Risk-TakingBehaviorDisruptive, Impulse Control, and Conduct DisordersMental DisordersSchizophrenia Spectrum and Other Psychotic Disorders

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PharmD, MSc, Pharmacist, Principal Investigator

Study Record Dates

First Submitted

December 29, 2022

First Posted

January 17, 2023

Study Start

November 1, 2019

Primary Completion

May 1, 2023

Study Completion

May 1, 2023

Last Updated

May 28, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

The participants of this study did not give written consent for their data to be shared publicly, so due to the sensitive nature of the research supporting data is not available.

Locations