NCT02739932

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
243

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2015

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 22, 2016

Completed
24 days until next milestone

First Posted

Study publicly available on registry

April 15, 2016

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

May 24, 2022

Status Verified

May 1, 2022

Enrollment Period

6.4 years

First QC Date

March 22, 2016

Last Update Submit

May 17, 2022

Conditions

Psychotic DisordersDepressive Disorder, MajorBipolar Disorder

Keywords

Attenuated Psychotic Symptoms

Outcome Measures

Primary Outcomes (1)

  • Diagnosis of serious mental illness (SMI)

    The Structured Clinical Interview for DSM-IV Disorders (SCID-1) will be used to determine the presence of any Axis I disorder

    2 year

Secondary Outcomes (11)

  • 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 SOPS.

    2 year

  • +6 more secondary outcomes

Eligibility Criteria

Age12 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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).

You may qualify if:

  • Participants will understand and sign an informed consent (or assent for minors) document in English.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mathison Centre for Research and Education, University of Calgary

Calgary, Alberta, T2N4Z6, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Psychotic DisordersDepressive Disorder, MajorBipolar Disorder

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersDepressive DisorderMood DisordersBipolar and Related Disorders

Study Officials

  • Jean Addington

    University of Calgary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 22, 2016

First Posted

April 15, 2016

Study Start

March 1, 2015

Primary Completion

August 1, 2021

Study Completion

August 1, 2021

Last Updated

May 24, 2022

Record last verified: 2022-05

Locations

CA(2)