Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2026-02-23 @ 1:53 PM
Study NCT ID:
NCT02739932
Status:
COMPLETED
Last Update Posted:
2022-05-24
First Post:
2016-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adolescent Mental Health: Canadian Psychiatric Risk and Outcome Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011618', 'term': 'Psychotic Disorders'}, {'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D001714', 'term': 'Bipolar Disorder'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 243}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2021-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-17', 'studyFirstSubmitDate': '2016-03-22', 'studyFirstSubmitQcDate': '2016-04-14', 'lastUpdatePostDateStruct': {'date': '2022-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnosis of serious mental illness (SMI)', 'timeFrame': '2 year', 'description': 'The Structured Clinical Interview for DSM-IV Disorders (SCID-1) will be used to determine the presence of any Axis I disorder'}], 'secondaryOutcomes': [{'measure': 'Level of risk on a Clinical Staging Model for Mental Health Disorders based on the Scale of Prodromal Symptoms (SOPS)', 'timeFrame': '2 year', 'description': '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.'}, {'measure': 'Level of risk on a Clinical Staging Model for Mental Health Disorders based on the Calgary Depression Scale for Schizophrenia (CDSS).', 'timeFrame': '2 year', 'description': '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.'}, {'measure': 'Level of risk on a Clinical Staging Model for Mental Health Disorders based on the Young Mania Scale', 'timeFrame': '2 year', 'description': '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.'}, {'measure': 'Clinical symptoms on the Young Mania Scale.', 'timeFrame': '2 year', 'description': "Individuals' clinical symptoms will be measured using scores on the Young Mania Scale."}, {'measure': 'Clinical symptoms on the SOPS.', 'timeFrame': '2 year', 'description': "Individuals' clinical symptoms will be measured using scores on positive symptoms on the SOPS."}, {'measure': 'Clinical symptoms on the CDSS.', 'timeFrame': '2 year', 'description': "Individuals' clinical symptoms of depression will be measured using scores on the CDSS."}, {'measure': 'Functioning', 'timeFrame': '2 year', 'description': 'Functioning will be assessed using Global Functioning (Social \\& Role)'}, {'measure': 'Structural brain changes', 'timeFrame': '2 year', 'description': 'MRI images will be examined for changes in structural data using regional grey matter intensity.'}, {'measure': 'Structural Brain changes', 'timeFrame': '2 year', 'description': 'MRI images will be examined for changes in structural data using white matter integrity'}, {'measure': 'Functional Brain changes', 'timeFrame': '2 year', 'description': 'MRI images will be examined for changes in functional data using resting-state connectivity among brain regions of interest'}, {'measure': 'Changes in cognition', 'timeFrame': '2 year', 'description': 'Cognition is assessed using the MATRICS Cognitive Battery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Attenuated Psychotic Symptoms'], 'conditions': ['Psychotic Disorders', 'Depressive Disorder, Major', 'Bipolar Disorder']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.\n\nInvestigators 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Young people aged 12-25 who report 1 of the following:\n\n1. early mood symptoms or sub-threshold psychotic symptoms (n=160);\n2. a family history of a SMI (n=80); or\n3. are healthy with no mental health concerns (n=40).', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants will understand and sign an informed consent (or assent for minors) document in English.\n\nExclusion Criteria:\n\n* 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);\n* IQ \\< 70;\n* past or current history of a significant central nervous system disorder or serious medical disorder; and\n* current pharmacological treatment that would be considered as an adequate trial of treatment for a SMI.'}, 'identificationModule': {'nctId': 'NCT02739932', 'acronym': 'PROCAN', 'briefTitle': 'Adolescent Mental Health: Canadian Psychiatric Risk and Outcome Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Calgary'}, 'officialTitle': 'Adolescent Mental Health: Canadian Psychiatric Risk and Outcome Study', 'orgStudyIdInfo': {'id': 'MIRI-14-3377'}}, 'contactsLocationsModule': {'locations': [{'zip': 'T2N4Z6', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Mathison Centre for Research and Education, University of Calgary', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Sunnybrook Health Sciences Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Jean Addington', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Calgary'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Calgary', 'class': 'OTHER'}, 'collaborators': [{'name': 'Brain Canada', 'class': 'OTHER'}, {'name': 'Sunnybrook Health Sciences Centre', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jean Addington, PhD', 'investigatorAffiliation': 'University of Calgary'}}}}