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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Laval University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 29, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 17, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 28, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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