Clinical trial NCT02739932: Adolescent Mental Health: Canadian Psychiatric Risk and Outcome Study
Official title: Adolescent Mental Health: Canadian Psychiatric Risk and Outcome Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psychotic Disorders
Depressive Disorder, Major
Bipolar Disorder
Keywords: Attenuated Psychotic Symptoms
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Brain Canada
name: Sunnybrook Health Sciences Centre
First posted: 2016-04-15
Enrollment: 243
Sex: ALL
Minimum age (years): 12
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Diagnosis of serious mental illness (SMI)
timeFrame: 2 year
Secondary outcomes:
measure: Level of risk on a Clinical Staging Model for Mental Health Disorders based on the Scale of Prodromal Symptoms (SOPS)
timeFrame: 2 year
measure: Level of risk on a Clinical Staging Model for Mental Health Disorders based on the Calgary Depression Scale for Schizophrenia (CDSS).
timeFrame: 2 year
measure: Level of risk on a Clinical Staging Model for Mental Health Disorders based on the Young Mania Scale
timeFrame: 2 year
measure: Clinical symptoms on the Young Mania Scale.
timeFrame: 2 year
measure: Clinical symptoms on the SOPS.
timeFrame: 2 year
measure: Clinical symptoms on the CDSS.
timeFrame: 2 year
measure: Functioning
timeFrame: 2 year
measure: Structural brain changes
timeFrame: 2 year
measure: Structural Brain changes
timeFrame: 2 year
measure: Functional Brain changes
timeFrame: 2 year
measure: Changes in cognition
timeFrame: 2 year
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Mathison Centre for Research and Education, University of Calgary
state: Alberta
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: University of Calgary
name: Jean Addington
role: PRINCIPAL_INVESTIGATOR
References: