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Gambling DisorderANTE-UPNCT05686772

Prospective Multicenter Cohort Study Evaluating the Incidence and Risk Factors for Problem Gambling Among Young Adults With First-episode Psychosis

An observational study of Gambling Disorder and Psychotic Disorders, run by Laval University at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 35 years
Conditions the study is for
Gambling Disorder, Psychotic Disorders
What is being tested?
Antipsychotic use, Psychiatric comorbidities and Sociodemographics/socioeconomic status
How many people
520 participants
Where
2 sitesCanada
Study dates
1 Nov 2019to 1 May 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • All sexes
  • No healthy volunteers
  • Adult

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).

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • Montreal University Hospital Center

    Montreal, Quebec, H2X 3E4

  • Quebec Mental Health University Institute

    Québec, Quebec, G1J 2G3

Other trials in Canada

About this study

Official title: A Better Understanding of the Association Between Problem Gambling and Psychotic Disorders in Young Adults: a New Path Towards Recovery

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:

Read more
  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.
Read the 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.

Being tested
Antipsychotic use, Psychiatric comorbidities, Sociodemographics/socioeconomic status, Gambling history, Clinical variables
Keywords
Gambling, Psychotic disorder, Schizophrenia, Cohort, Multicenter, Prospective, Observational, Incidence, Risk factors
Medical subject headings
Gambling, Psychotic Disorders, Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Antipsychotic useDrug

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

  • Psychiatric comorbiditiesOther

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

  • Sociodemographics/socioeconomic statusOther

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

  • Gambling historyOther

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

  • Clinical variablesOther

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

Study groups in NCT05686772
Study groupRoleWhat they receive
First-episode psychosis patientsAll patients aged 18-35 years with a diagnosis of FEP admitted at two FEP programs in the province of Quebec, Canada.
Receives: Drug: Antipsychotic use; Other: Psychiatric comorbidities; Other: Sociodemographics/socioeconomic status; Other: Gambling history; Other: Clinical variables

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Problem gambling

    1. 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

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jan 2023
  2. Study start1 Nov 2019
  3. Primary completion1 May 2023
  4. Study completion1 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
520 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05686772
Sponsor's protocol ID
2020-OJUR-286304
Acronym
ANTE-UP
Status last verified
May 2025
First submitted
29 Dec 2022
Last updated
28 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • 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.

    PubMed 33713298

  • 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.

    PubMed 32134855

  • 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.

    PubMed 31206391

  • 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.

    PubMed 19538900

  • 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.

    PubMed 25684263

  • 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.

    PubMed 29865864

  • 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.

    PubMed 37098506

Questions about this trial

What is this clinical trial studying?

An observational study of Gambling Disorder and Psychotic Disorders, run by Laval University at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Problem gambling (time frame: 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05686772, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.

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