Adolescent Mental Health: Canadian Psychiatric Risk and Outcome Study (PROCAN)

The primary study aims are to determine the clinical, behavioural and social predictors of SMI development in youth, and to investigate whether neuroimaging can distinguish youth who will develop SMI from those who will not.

The study's secondary aims are to examine the proportions of the cohort that make transitions between the different clinical stages of risk, and to determine the proportions that have poor outcomes, defined as ongoing or increased symptoms, secondary substance misuse, poor social or role functioning, i.e., non-participation in education, or employment, and new self-harm.

Investigators will study a cohort of 240 youth (aged 14-25, male and female) that includes youth with early mood symptoms or sub-threshold psychotic symptoms (symptomatic group; n=160), youth at risk due to a family history of a SMI (family high risk (FHR); n=40), and healthy controls (HC; n=40). From this cohort, clinical, social and cognitive data, as well as imaging data will be gathered to create a multi-layered "snapshot" of these individuals and provide full-level characterization. Investigators will use the full range of clinical and imaging data generated from this cohort to develop novel prediction algorithms incorporating key variables that predict the development of SMI.

Study Overview

• Status: Completed
• Conditions: Psychotic Disorders; Bipolar Disorder; Depressive Disorder, Major

• Study Type: Observational
• Enrollment (Actual): 243

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N4Z6
      • Mathison Centre for Research and Education, University of Calgary
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Young people aged 12-25 who report 1 of the following:

1. early mood symptoms or sub-threshold psychotic symptoms (n=160);
2. a family history of a SMI (n=80); or
3. are healthy with no mental health concerns (n=40).

Description

Inclusion Criteria:

• Participants will understand and sign an informed consent (or assent for minors) document in English.

Exclusion Criteria:

• meet criteria for current or lifetime Axis I bipolar or psychotic disorder (other Axis I disorders will not be exclusionary as they may be precursors to mood or psychotic disorders);
• IQ < 70;
• past or current history of a significant central nervous system disorder or serious medical disorder; and
• current pharmacological treatment that would be considered as an adequate trial of treatment for a SMI.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnosis of serious mental illness (SMI)	The Structured Clinical Interview for DSM-IV Disorders (SCID-1) will be used to determine the presence of any Axis I disorder	2 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of risk on a Clinical Staging Model for Mental Health Disorders based on the Scale of Prodromal Symptoms (SOPS)	Level of risk will be defined based on a Clinical Staging Model for Mental Health Disorders (Hickie IB, Scott EM, Hermens DF et al. Applying clinical staging to young people who present for mental health care. Early Interv Psychiatry 2012.) Individuals will be assigned a stage based on their scores on the SOPS.	2 year
Level of risk on a Clinical Staging Model for Mental Health Disorders based on the Calgary Depression Scale for Schizophrenia (CDSS).	Level of risk will be defined based on a Clinical Staging Model for Mental Health Disorders (Hickie IB, Scott EM, Hermens DF et al. Applying clinical staging to young people who present for mental health care. Early Interv Psychiatry 2012.) Individuals will be assigned a stage based on scores on the CDSS.	2 year
Level of risk on a Clinical Staging Model for Mental Health Disorders based on the Young Mania Scale	Level of risk will be defined based on a Clinical Staging Model for Mental Health Disorders (Hickie IB, Scott EM, Hermens DF et al. Applying clinical staging to young people who present for mental health care. Early Interv Psychiatry 2012.) Individuals will be assigned a stage based on their scores on the Young Mania Scale.	2 year
Clinical symptoms on the Young Mania Scale.	Individuals' clinical symptoms will be measured using scores on the Young Mania Scale.	2 year
Clinical symptoms on the SOPS.	Individuals' clinical symptoms will be measured using scores on positive symptoms on the SOPS.	2 year
Clinical symptoms on the CDSS.	Individuals' clinical symptoms of depression will be measured using scores on the CDSS.	2 year
Functioning	Functioning will be assessed using Global Functioning (Social & Role)	2 year
Structural brain changes	MRI images will be examined for changes in structural data using regional grey matter intensity.	2 year
Structural Brain changes	MRI images will be examined for changes in structural data using white matter integrity	2 year
Functional Brain changes	MRI images will be examined for changes in functional data using resting-state connectivity among brain regions of interest	2 year
Changes in cognition	Cognition is assessed using the MATRICS Cognitive Battery	2 year

Collaborators and Investigators

• Sponsor: University of Calgary
• Collaborators: Sunnybrook Health Sciences Centre; Brain Canada
• Investigators: Principal Investigator: Jean Addington, University of Calgary

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): August 1, 2021
• Study Completion (Actual): August 1, 2021

Study Registration Dates

• First Submitted: March 22, 2016
• First Submitted That Met QC Criteria: April 14, 2016
• First Posted (Estimate): April 15, 2016

Study Record Updates

• Last Update Posted (Actual): May 24, 2022
• Last Update Submitted That Met QC Criteria: May 17, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Attenuated Psychotic Symptoms
• Additional Relevant MeSH Terms: Pathologic Processes; Mood Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Bipolar and Related Disorders; Depressive Disorder; Disease; Psychotic Disorders; Mental Disorders; Bipolar Disorder; Depressive Disorder, Major
• Other Study ID Numbers: MIRI-14-3377