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

May 21, 2025 updated by: Olivier Corbeil, Laval University

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:

  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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

520

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1J 2G3
        • Quebec Mental Health University Institute
    • Quebec
      • Montreal, Quebec, Canada, H2X 3E4
        • Montreal University Hospital Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

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).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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 use
Use of first/second generation antipsychotics, use of third-generation antipsychotics, use of aripiprazole specifically
Other: Psychiatric comorbidities
Substance use disorders, cluster B personality disorders, anxiety disorder, major depressive disorder, attention-deficit/hyperactivity disorder, tobacco smoking
Other: Sociodemographics/socioeconomic status
Age, gender identity, ethnicity, highest educational attainment, employment, at school, homelessness, in a relationship
Other: Gambling history
Non-problematic gambling at the time of admission and/or previous 12 months
Other: Clinical variables
Main psychiatric diagnosis, history of psychiatric hospitalizations, severity of illness (CGI-S), functioning (SOFAS), concomitant psychotropic medications use

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Problem gambling
Time Frame: At baseline (i.e., at admission in the clinic)
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)
Problem gambling
Time Frame: At 6 months
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
Problem gambling
Time Frame: At 12 months
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
Problem gambling
Time Frame: At 18 months
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
Problem gambling
Time Frame: At 24 months
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
Problem gambling
Time Frame: At 30 months
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
Problem gambling
Time Frame: At 36 months
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laval University

Collaborators

Fonds de la Recherche en Santé du Québec

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2019

Primary Completion (Actual)

May 1, 2023

Study Completion (Actual)

May 1, 2023

Study Registration Dates

First Submitted

December 29, 2022

First Submitted That Met QC Criteria

January 9, 2023

First Posted (Actual)

January 17, 2023

Study Record Updates

Last Update Posted (Actual)

May 28, 2025

Last Update Submitted That Met QC Criteria

May 21, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-OJUR-286304

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Psychotic Disorders

Clinical Trials on Antipsychotic use

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Brazil

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe