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Clinical Trials/NCT02739932
NCT02739932
Completed
Not Applicable

Adolescent Mental Health: Canadian Psychiatric Risk and Outcome Study

University of Calgary2 sites in 1 country243 target enrollmentMarch 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Psychotic Disorders
Sponsor
University of Calgary
Enrollment
243
Locations
2
Primary Endpoint
Diagnosis of serious mental illness (SMI)
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2015
End Date
August 2021
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jean Addington, PhD

Professor

University of Calgary

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.

Outcomes

Primary Outcomes

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

  • Level of risk on a Clinical Staging Model for Mental Health Disorders based on the Scale of Prodromal Symptoms (SOPS)(2 year)
  • Level of risk on a Clinical Staging Model for Mental Health Disorders based on the Calgary Depression Scale for Schizophrenia (CDSS).(2 year)
  • Level of risk on a Clinical Staging Model for Mental Health Disorders based on the Young Mania Scale(2 year)
  • Clinical symptoms on the Young Mania Scale.(2 year)
  • Clinical symptoms on the CDSS.(2 year)
  • Functioning(2 year)
  • Structural brain changes(2 year)
  • Clinical symptoms on the SOPS.(2 year)
  • Structural Brain changes(2 year)
  • Changes in cognition(2 year)
  • Functional Brain changes(2 year)

Study Sites (2)

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