Psychotic DisordersPROCANNCT02739932
Adolescent Mental Health: Canadian Psychiatric Risk and Outcome Study
An observational study of Psychotic Disorders and Depressive Disorder, Major, run by University of Calgary at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychotic Disorders, Depressive Disorder, Major, Bipolar Disorder
- How many people
- 243 participants
- Where
- 2 sitesCanada
- Study dates
- Mar 2015to Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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).
Who may be able to join
- Participants will understand and sign an informed consent (or assent for minors) document in English.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Mathison Centre for Research and Education, University of Calgary
Calgary, Alberta, T2N4Z6
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
About this 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.
- Keywords
- Attenuated Psychotic Symptoms
- Medical subject headings
- Psychotic Disorders, Depressive Disorder, Major, Bipolar Disorder
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
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.
Measured: 2 year
Level of risk on a Clinical Staging Model for Mental Health Disorders based on the Calgary Depression Scale for Schizophrenia (CDSS).
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.
Measured: 2 year
Level of risk on a Clinical Staging Model for Mental Health Disorders based on the Young Mania Scale
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.
Measured: 2 year
Clinical symptoms on the Young Mania Scale.
Individuals' clinical symptoms will be measured using scores on the Young Mania Scale.
Measured: 2 year
Clinical symptoms on the SOPS.
Individuals' clinical symptoms will be measured using scores on positive symptoms on the SOPS.
Measured: 2 year
Clinical symptoms on the CDSS.
Individuals' clinical symptoms of depression will be measured using scores on the CDSS.
Measured: 2 year
Functioning
Functioning will be assessed using Global Functioning (Social \& Role)
Measured: 2 year
Structural brain changes
MRI images will be examined for changes in structural data using regional grey matter intensity.
Measured: 2 year
Structural Brain changes
MRI images will be examined for changes in structural data using white matter integrity
Measured: 2 year
Functional Brain changes
MRI images will be examined for changes in functional data using resting-state connectivity among brain regions of interest
Measured: 2 year
Changes in cognition
Cognition is assessed using the MATRICS Cognitive Battery
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study startMar 2015
- Primary completionAug 2021
- Study completionAug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychotic DisordersStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 243 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Brain Canada, Sunnybrook Health Sciences Centre
- Responsible party
- Principal investigator, Jean Addington, PhD, University of Calgary
- Investigators
- Jean Addington, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02739932
- Sponsor's protocol ID
- MIRI-14-3377
- Acronym
- PROCAN
- Status last verified
- May 2022
- First submitted
- 22 Mar 2016
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adolescent Mental Health: Canadian Psychiatric Risk and Outcome Study
- ClinicalTrials.gov ID
- NCT02739932
- Acronym / sponsor ID
- PROCAN / MIRI-14-3377
- Keywords
- Attenuated Psychotic Symptoms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 243 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Brain Canada, Sunnybrook Health Sciences Centre
- Study start
- Mar 2015
- Primary completion
- Aug 2021 (actual)
- Study completion
- Aug 2021 (actual)
- First posted
- 15 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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).
Key inclusion criteria (1 listed)
- Participants will understand and sign an informed consent (or assent for minors) document in English.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
11 secondary outcomes
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 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 on a Clinical Staging Model for Mental Health Disorders based on the Young Mania Scale
Time frame: 2 year
Clinical symptoms on the Young Mania Scale.
Time frame: 2 year
Clinical symptoms on the SOPS.
Time frame: 2 year
Clinical symptoms on the CDSS.
Time frame: 2 year
Functioning
Time frame: 2 year
Structural brain changes
Time frame: 2 year
Structural Brain changes
Time frame: 2 year
Functional Brain changes
Time frame: 2 year
Changes in cognition
Time frame: 2 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Addington principal investigator
University of Calgary
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychotic Disorders and Depressive Disorder, Major, run by University of Calgary at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of serious mental illness (SMI) (time frame: 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2022.