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Adolescent Mental Health: Canadian Psychiatric Risk and Outcome Study (PROCAN)

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ClinicalTrials.gov Identifier: NCT02739932
Recruitment Status : Recruiting
First Posted : April 15, 2016
Last Update Posted : November 1, 2016
Sponsor:
Collaborators:
Information provided by (Responsible Party):

March 22, 2016
April 15, 2016
November 1, 2016
March 2015
June 2017   (Final data collection date for primary outcome measure)
Diagnosis of serious mental illness (SMI) [ Time Frame: 1 year ]
The Structured Clinical Interview for DSM-IV Disorders (SCID-1) will be used to determine the presence of any Axis I disorder
Same as current
Complete list of historical versions of study NCT02739932 on ClinicalTrials.gov Archive Site
  • Level of risk on a Clinical Staging Model for Mental Health Disorders based on the Scale of Prodromal Symptoms (SOPS) [ Time Frame: 1 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). [ Time Frame: 1 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 [ Time Frame: 1 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. [ Time Frame: 1 year ]
    Individuals' clinical symptoms will be measured using scores on the Young Mania Scale.
  • Clinical symptoms on the SOPS. [ Time Frame: 1 year ]
    Individuals' clinical symptoms will be measured using scores on positive symptoms on the SOPS.
  • Clinical symptoms on the CDSS. [ Time Frame: 1 year ]
    Individuals' clinical symptoms of depression will be measured using scores on the CDSS.
  • Functioning [ Time Frame: 1 year ]
    Functioning will be assessed using Global Functioning (Social & Role)
  • Structural brain changes [ Time Frame: 1 year ]
    MRI images will be examined for changes in structural data using regional grey matter intensity.
  • Structural Brain changes [ Time Frame: 1 year ]
    MRI images will be examined for changes in structural data using white matter integrity
  • Functional Brain changes [ Time Frame: 1 year ]
    MRI images will be examined for changes in functional data using resting-state connectivity among brain regions of interest
  • Changes in cognition [ Time Frame: 1 year ]
    Cognition is assessed using the MATRICS Cognitive Battery
Same as current
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Adolescent Mental Health: Canadian Psychiatric Risk and Outcome Study
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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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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).
  • Psychotic Disorders
  • Depressive Disorder, Major
  • Bipolar Disorder
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
240
June 2018
June 2017   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
12 Years to 25 Years   (Child, Adult)
Yes
Contact: Catherine Marshall 403.210.7335 cemarsha@ucalgary.ca
Contact: Aaron Peterson 403.210.8740 ajpeters@ucalgary.ca
Canada
 
 
NCT02739932
MIRI-14-3377
No
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Jean Addington, PhD, University of Calgary
University of Calgary
  • Brain Canada
  • Sunnybrook Health Sciences Centre
Principal Investigator: Jean Addington University of Calgary
University of Calgary
October 2016