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Completed

NCT Number: NCT05686772

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

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.

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Key information

Conditions

Gambling Disorder Behavior Disruptive, Impulse Control, and Conduct Disorders Gambling Mental Disorders Psychotic Disorders Risk-Taking Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Montreal University Hospital Center, Montreal, Quebec, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Antipsychotic use

Drug

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

Psychiatric comorbidities

Other

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

Sociodemographics/socioeconomic status

Other

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

Gambling history

Other

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

Clinical variables

Other

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

Primary outcomes

  1. 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.

    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

Other outcomes

  1. Sensitivity analysis restricted to DSM-5 gambling disorder

    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.

    DSM-5 diagnosis of gambling disorder by treating psychiatrist

Sponsors and collaborators

Lead sponsor

Laval University

Other

Collaborators

  • Fonds de la Recherche en Santé du Québec

Registry information

Official study title

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

Acronym: ANTE-UP

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jan 17, 2023
Registry last updated
May 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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