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Adolescent Mental Health: Canadian Psychiatric Risk and Outcome Study

Adolescent Mental Health: Canadian Psychiatric Risk and Outcome Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02739932
Acronym
PROCAN
Enrollment
243
Registered
2016-04-15
Start date
2015-03-31
Completion date
2021-08-31
Last updated
2022-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder, Depressive Disorder, Major, Psychotic Disorders

Keywords

Attenuated Psychotic Symptoms

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.

Interventions

None listed

Sponsors

Brain Canada
CollaboratorOTHER
Sunnybrook Health Sciences Centre
CollaboratorOTHER
University of Calgary
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
12 Years to 25 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Diagnosis of serious mental illness (SMI)2 yearThe Structured Clinical Interview for DSM-IV Disorders (SCID-1) will be used to determine the presence of any Axis I disorder

Secondary

MeasureTime frameDescription
Level of risk on a Clinical Staging Model for Mental Health Disorders based on the Calgary Depression Scale for Schizophrenia (CDSS).2 yearLevel 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 Scale2 yearLevel 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 yearIndividuals' clinical symptoms will be measured using scores on the Young Mania Scale.
Clinical symptoms on the SOPS.2 yearIndividuals' clinical symptoms will be measured using scores on positive symptoms on the SOPS.
Clinical symptoms on the CDSS.2 yearIndividuals' clinical symptoms of depression will be measured using scores on the CDSS.
Level of risk on a Clinical Staging Model for Mental Health Disorders based on the Scale of Prodromal Symptoms (SOPS)2 yearLevel 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.
Structural brain changes2 yearMRI images will be examined for changes in structural data using regional grey matter intensity.
Structural Brain changes2 yearMRI images will be examined for changes in structural data using white matter integrity
Functional Brain changes2 yearMRI images will be examined for changes in functional data using resting-state connectivity among brain regions of interest
Changes in cognition2 yearCognition is assessed using the MATRICS Cognitive Battery
Functioning2 yearFunctioning will be assessed using Global Functioning (Social & Role)

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026