Adolescent Mental Health: Canadian Psychiatric Risk and Outcome Study

Bipolar Disorder Clinical Trial

— PROCAN  

Official title:

Adolescent Mental Health: Canadian Psychiatric Risk and Outcome Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02739932
• Other study ID #: MIRI-14-3377
• Status: Completed
• Start date: March 2015
• Est. completion date: August 2021

Study information

• Verified date: May 2022
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 243
• Est. completion date: August 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bipolar Disorder
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Mental Disorders
• Psychotic Disorders

Locations

Country	Name	City	State
Canada	Mathison Centre for Research and Education, University of Calgary	Calgary	Alberta
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
University of Calgary	Brain Canada, Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Clinical symptoms on the Young Mania Scale.	Individuals' clinical symptoms will be measured using scores on the Young Mania Scale.	2 year
Secondary	Clinical symptoms on the SOPS.	Individuals' clinical symptoms will be measured using scores on positive symptoms on the SOPS.	2 year
Secondary	Clinical symptoms on the CDSS.	Individuals' clinical symptoms of depression will be measured using scores on the CDSS.	2 year
Secondary	Functioning	Functioning will be assessed using Global Functioning (Social & Role)	2 year
Secondary	Structural brain changes	MRI images will be examined for changes in structural data using regional grey matter intensity.	2 year
Secondary	Structural Brain changes	MRI images will be examined for changes in structural data using white matter integrity	2 year
Secondary	Functional Brain changes	MRI images will be examined for changes in functional data using resting-state connectivity among brain regions of interest	2 year
Secondary	Changes in cognition	Cognition is assessed using the MATRICS Cognitive Battery	2 year