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Trial record 42 of 208 for:    Recruiting, Not yet recruiting, Available Studies | "Mental Health"

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:
Brain Canada
Sunnybrook Health Sciences Centre
Information provided by (Responsible Party):
Jean Addington, PhD, University of Calgary

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.


Condition or disease
Psychotic Disorders Depressive Disorder, Major Bipolar Disorder

Study Type : Observational
Estimated Enrollment : 240 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Adolescent Mental Health: Canadian Psychiatric Risk and Outcome Study
Study Start Date : March 2015
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. Clinical symptoms on the Young Mania Scale. [ Time Frame: 1 year ]
    Individuals' clinical symptoms will be measured using scores on the Young Mania Scale.

  5. Clinical symptoms on the SOPS. [ Time Frame: 1 year ]
    Individuals' clinical symptoms will be measured using scores on positive symptoms on the SOPS.

  6. Clinical symptoms on the CDSS. [ Time Frame: 1 year ]
    Individuals' clinical symptoms of depression will be measured using scores on the CDSS.

  7. Functioning [ Time Frame: 1 year ]
    Functioning will be assessed using Global Functioning (Social & Role)

  8. Structural brain changes [ Time Frame: 1 year ]
    MRI images will be examined for changes in structural data using regional grey matter intensity.

  9. Structural Brain changes [ Time Frame: 1 year ]
    MRI images will be examined for changes in structural data using white matter integrity

  10. 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

  11. Changes in cognition [ Time Frame: 1 year ]
    Cognition is assessed using the MATRICS Cognitive Battery



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02739932


Contacts
Contact: Catherine Marshall 403.210.7335 cemarsha@ucalgary.ca
Contact: Aaron Peterson 403.210.8740 ajpeters@ucalgary.ca

Locations
Canada, Alberta
Mathison Centre for Research and Education, University of Calgary Recruiting
Calgary, Alberta, Canada, T2N4Z6
Contact: Catherine Marshall    4032107335    cemarsha@ucalgary.ca   
Sub-Investigator: Glenda MacQueen         
Sub-Investigator: Signe Bray         
Sub-Investigator: JianLi Wang         
Sub-Investigator: Catherine Lebel         
Principal Investigator: Jean Addington         
Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Benjamin Goldstein, M.D    1416.480.6100    benjamin.goldstein@sunnybrook.ca   
Sub-Investigator: Benjamin Goldstein         
Sub-Investigator: Jonathan Downar         
Sub-Investigator: Sidney H Kennedy         
Sponsors and Collaborators
University of Calgary
Brain Canada
Sunnybrook Health Sciences Centre
Investigators
Principal Investigator: Jean Addington University of Calgary

Responsible Party: Jean Addington, PhD, Professor, University of Calgary
ClinicalTrials.gov Identifier: NCT02739932     History of Changes
Other Study ID Numbers: MIRI-14-3377
First Posted: April 15, 2016    Key Record Dates
Last Update Posted: November 1, 2016
Last Verified: October 2016

Keywords provided by Jean Addington, PhD, University of Calgary:
Attenuated Psychotic Symptoms

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Bipolar Disorder
Mental Disorders
Psychotic Disorders
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Behavioral Symptoms
Bipolar and Related Disorders
Schizophrenia Spectrum and Other Psychotic Disorders