Adolescent Mental Health: Canadian Psychiatric Risk and Outcome Study

Completed

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

• Registration Number: NCT02739932
• Lead Sponsor: University of Calgary

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2016-03-22
• Study First Submitted QC: 2016-04-14
• Study First Posted: 2016-04-15
• Primary Completion: 2021-08
• Study Completion: 2021-08
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-17
• Last Update Posted: 2022-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 243

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Level of risk on a Clinical Staging Model for Mental Health Disorders based on the Scale of Prodromal Symptoms (SOPS)	2 year	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.
Level of risk on a Clinical Staging Model for Mental Health Disorders based on the Calgary Depression Scale for Schizophrenia (CDSS).	2 year	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.
Level of risk on a Clinical Staging Model for Mental Health Disorders based on the Young Mania Scale	2 year	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.
Clinical symptoms on the Young Mania Scale.	2 year	Individuals' clinical symptoms will be measured using scores on the Young Mania Scale.
Clinical symptoms on the CDSS.	2 year	Individuals' clinical symptoms of depression will be measured using scores on the CDSS.
Functioning	2 year	Functioning will be assessed using Global Functioning (Social \& Role)
Structural brain changes	2 year	MRI images will be examined for changes in structural data using regional grey matter intensity.
Clinical symptoms on the SOPS.	2 year	Individuals' clinical symptoms will be measured using scores on positive symptoms on the SOPS.
Structural Brain changes	2 year	MRI images will be examined for changes in structural data using white matter integrity
Changes in cognition	2 year	Cognition is assessed using the MATRICS Cognitive Battery
Functional Brain changes	2 year	MRI images will be examined for changes in functional data using resting-state connectivity among brain regions of interest

Trial Locations

Locations (2)

Mathison Centre for Research and Education, University of Calgary; 🇨🇦 Calgary, Alberta, Canada

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada