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Completed

NCT Number: NCT02739932

Adolescent Mental Health: Canadian Psychiatric Risk and Outcome Study

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.

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Key information

Conditions

Psychotic Disorders Bipolar Disorder Bipolar and Related Disorders Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

12 year–25 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Diagnosis of serious mental illness (SMI)

    Time frame: 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 outcomes

  1. Level of risk on a Clinical Staging Model for Mental Health Disorders based on the Scale of Prodromal Symptoms (SOPS)

    Time frame: 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.

  2. Level of risk on a Clinical Staging Model for Mental Health Disorders based on the Calgary Depression Scale for Schizophrenia (CDSS).

    Time frame: 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.

  3. Level of risk on a Clinical Staging Model for Mental Health Disorders based on the Young Mania Scale

    Time frame: 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.

  4. Clinical symptoms on the Young Mania Scale.

    Time frame: 2 year

    Individuals' clinical symptoms will be measured using scores on the Young Mania Scale.

  5. Clinical symptoms on the SOPS.

    Time frame: 2 year

    Individuals' clinical symptoms will be measured using scores on positive symptoms on the SOPS.

  6. Clinical symptoms on the CDSS.

    Time frame: 2 year

    Individuals' clinical symptoms of depression will be measured using scores on the CDSS.

  7. Functioning

    Time frame: 2 year

    Functioning will be assessed using Global Functioning (Social & Role)

  8. Structural brain changes

    Time frame: 2 year

    MRI images will be examined for changes in structural data using regional grey matter intensity.

  9. Structural Brain changes

    Time frame: 2 year

    MRI images will be examined for changes in structural data using white matter integrity

  10. Functional Brain changes

    Time frame: 2 year

    MRI images will be examined for changes in functional data using resting-state connectivity among brain regions of interest

  11. Changes in cognition

    Time frame: 2 year

    Cognition is assessed using the MATRICS Cognitive Battery

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Collaborators

  • Brain Canada
  • Sunnybrook Health Sciences Centre

Registry information

Acronym: PROCAN

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Apr 15, 2016
Registry last updated
May 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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