Depression - Major Depressive DisorderBLOOMNCT06978452
Behavioural Development, Long-term Outcomes and Opportunities to Optimize Youth Mental Health Trajectories
An observational study of Depression - Major Depressive Disorder and Bipolar, run by Douglas Mental Health University Institute at 1 site in Canada.
Trial summary
Behavioural Development, Long-term Outcomes and Opportunities to Optimize Youth Mental Health (BLOOM) is a project that aims to overcome age and diagnostic boundaries to generate person-specific longitudinal profiles of mental health in youth aged 9 to 25. Read more about this study
- Who is it for?
- Ages 9 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression - Major Depressive Disorder, Bipolar, Psychosis
- How many people
- 560 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jul 2024to 1 Jul 2029
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 9 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Help-seeking group: Primary care mental health service providers within the CIUSSS-ODIM catchment area will be the major referral source for this group. Youth and families referred to or self-referring for mental health needs to CLSCs at Dorval-Lachine-LaSalle, CLSC Pierrefonds/Lac-Saint-Louis, Social Paediatrics Clinics and Aire-Ouverte centres throughout the CIUSSS-West Island catchment will be approached by a member of these programmes to assess interest. A screening contact (on site or via telephone) by a member of the research team (who will work on site with clinical teams) will follow to review eligibility criteria. To increase uptake and reduce clinician burden, information leaflets and posters will be made available at the waiting rooms, webpages and social media sites of these youth programmes (See the leaflet: Portraying Your Mental Health). Non help-seeking group: Parents referral pathway: For this group, youth will be recruited through their parents, who are current
Who may be able to join
- Youth between 9 to 25 years of age at inclusion, who are able to read and understand either French or English, with at least one parent or legal guardian available to consent for those under 18 years of age.
- Specific eligibility criteria:
- Help-seeking group: At least one help-seeking contact made with a primary care clinical service provider or agency (e.g, paediatric/family physician clinic, CLSC or Aire Ouverte) for a mental health concern (i.e., clinical needs).
- Non help-seeking group:
- At least one of the birth parents or siblings have received psychiatric care for a diagnosis of DMDs (i.e., family needs) OR Being in contact with community agencies that provide youth-centred social services for food, housing, social discrimination (e.g., racialized youth, LGBTQ2SIA+) (i.e., social needs) OR Having a diagnosed chronic physical illness that is expected to require treatment for >12 months (e.g., diabetes, asthma to name a few) (i.e., physical health needs)
Who cannot join
- Due to the requirements of assessment procedures, youth who cannot communicate verbally due to known neurological conditions or intellectual disabilities will not be included. Youth who are already diagnosed with one of the DMDs by a physician and currently prescribed a treatment targeting the diagnosed condition (pharmacological or psychotherapeutic interventions), will not be eligible for inclusion.
- Importantly, no one will be excluded based on sex, gender, health insurance status, ethnicity, income status, ability to travel or living arrangements. If a participant initially approached through the referral pathways for non help-seeking individuals turns out to have had at least one help-seeking contact for a mental health concern (i.e., clinical needs), the participant will still be included but classified as part of the help-seeking group. We anticipate non help-seeking referrals to satisfy more than one criteria. Their occurrence and distribution will be recorded in detail as part of our assessment procedure.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Centre intégré universitaire de santé et de services sociaux (CIUSSS) de l'Ouest-de-l'Île-de-Montréal
Montreal, Quebec, H4H 1R3
Céline Villemus Project Manager, Msc, 514-761-6131 ext. 2125, celine.villemus.comtl@ssss.gouv.qc.ca
About this study
Behavioural Development, Long-term Outcomes and Opportunities to Optimize Youth Mental Health (BLOOM) is a project that aims to overcome age and diagnostic boundaries to generate person-specific longitudinal profiles of mental health in youth aged 9 to 25. The overarching objective is to lay the informational foundation to accurately predict both clinical outcomes and opportunities to optimize health trajectories. This project will recruit youth in need without any mental health diagnosis and follow them annually for 5 years. The present study includes assessment of antecedents, opportunities and outcomes that will establish eligibility for preventive interventions
Read the detailed description
We propose an accelerated longitudinal study design that allows covering a long developmental period (9 to 25 years) in a short study time (5 years follow-up). Youth and family caregivers will be recruited from various sources and followed-up annually for the first five years. Beyond this 5-year period, further follow-ups will depend on continued study funding and may be either annual or less frequent (e.g. every 3-4 years), and either interview-based or restricted to administrative data. The present study includes assessment of antecedents, opportunities and outcomes that will establish eligibility for preventive interventions; any randomised intervention studies based on this cohort will be based on the outcome for specific REB submissions in the future.
Predicting the onset of DMDs using a set of readily accessible antecedents
We hypothesise that youth who develop DMDs will have higher severity and frequency of antecedents compared to those who do not develop this outcome. We anticipate that a clinically meaningful prediction (i.e., with accuracy 80% or more said to be good or excellent, while less than 60% is deemed not meaningful; many existing predictors perform at 60-80% range9) of DMDs can be made with the set of readily measurable antecedents. We will estimate the strength of antecedent-outcome relationship separately in the two (help-seeking or non help-seeking) subgroups. While we expect variations in the rates of outcomes (help-seeking > non-help seeking), we hypothesise that the relationship between antecedents and DMDs will be similar across the groups with no major drop in the ability to predict outcome in any subgroup (i.e. >60% accuracy in each, below which prediction is unlikely to be of any clinical benefit59).
Relationship between predictive antecedents, resilience and biobehavioural markers
In the consenting subsample, we will assess if the polygenic risk of individual disorders/pathways and summary measures of brain health (age-appropriate structure, chemisty, function) differ between those who develop DMDs and those who do not. We will subsequently test if measures with highest effect size differences, if any, will improve the accuracy (discrimination index) for outcome prediction by at least 10% to assess their suitability for routine clinical implementation.
Of note, we propose this study as a part of a longer program whose first phase will be for 5 years duration. We anticipate following up this cohort for a longer period in phase 2, and embedding clinical trials in the cohort in future (not described here).
- Conditions
- Depression - Major Depressive Disorder, Bipolar, Psychosis, Eating Disorder NOS, ADHD, Substance Use Disorder (SUD)
- Keywords
- antecedents, mental health prevention, resilience, access to care, help-seeking, youth in needs, biomarker, speech, language, cognition
- Medical subject headings
- Psychotic Disorders, Feeding and Eating Disorders, Attention Deficit Disorder with Hyperactivity, Substance-Related Disorders, Speech, Language
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Help seeking group | Primary care mental health service providers within the CIUSSS-ODIM catchment area will be the major referral source for this group. Youth and families referred to or self-referring for mental health needs to CLSCs at Dorval-Lachine-LaSalle, CLSC Pierrefonds/Lac-Saint-Louis, Social Paediatrics Clinics and Aire-Ouverte centres throughout the CIUSSS-West Island catchment will be approached by a member of these programmes to assess interest. A screening contact (on site or via telephone) by a member of the research team (who will work on site with clinical teams) will follow to review eligibility criteria. To increase uptake and reduce clinician burden, information leaflets and posters will be made available at the waiting rooms, webpages and social media sites of these youth programmes. | |
| Non help seeking group | Parents referral pathway: Youth will be recruited through their parents, patients of psychiatric clinics at the CIUSSS-ODIM. Parents will be approached by health professionals. A screening contact by a member of the research team will follow to review eligibility criteria. Other form of recruitment is non-profit organisations serving people living with mental illness, such as the Schizophrenia Society of Quebec as well as primary care practitioners caring for parents satisfying the eligibility criteria. Information leaflets and posters will be made available at the waiting rooms of these clinics and shared with the partner agencies. Social agencies referral pathway: Youth who have contacts with community agencies that provide various forms of social assistance will be recruited through printed and digital advertising. Direct contacts as well as referrals from agency workers and volunteers will be screened by a member of the research team. Physical health based referral pathway: Adv |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of new onsets of one of the seven mental illnesses as per DSM-5 criteria
By applying a detailed diagnostic screen we will be able to capture all emerging mental illnesses as per the existing schedule of classification if present. But our primary outcome of interest (DMDs) is defined as a new onset of illnesses known to involve substantial functional impairment over multiple domains. These are moderate/severe major depressive disorder, bipolar disorder type I or type 2, schizoaffective disorder, schizophrenia, or schizophreniform disorder, anorexia and bulimia nervosa, OCD, moderate/severe ADHD, moderate or severe substance use disorder (SUD) all according to DSM-5 (as per DSM-5 Text Revision, updated September 2023). Notably, while epidemiological data indicates that features of some of these disorders (e.g. ADHD, OCD) begin at ages younger than 9, the mean age of diagnosis continues to be much later in practice.
Measured: From screening to 5 years of follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start1 Jul 2024
- Primary completion1 Jul 2029 (estimated)
- Study completion1 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression - Major Depressive DisorderStudies of the same condition, open and under way.
- 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
- 560 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Douglas Mental Health University Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lena Palaniyappan, Douglas Mental Health University Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06978452
- Sponsor's protocol ID
- 2024-960
- Acronym
- BLOOM
- Status last verified
- Nov 2024
- First submitted
- 11 May 2025
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioural Development, Long-term Outcomes and Opportunities to Optimize Youth Mental Health Trajectories
- ClinicalTrials.gov ID
- NCT06978452
- Acronym / sponsor ID
- BLOOM / 2024-960
- Conditions
- Depression - Major Depressive Disorder, Bipolar, Psychosis, Eating Disorder NOS, ADHD, Substance Use Disorder (SUD)
- Keywords
- antecedents, mental health prevention, resilience, access to care, help-seeking, youth in needs, biomarker, speech
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 560 participants (estimated)
- Lead sponsor
- Douglas Mental Health University InstituteUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Jul 2029 (estimated)
- Study completion
- 1 Jul 2029 (estimated)
- First posted
- 18 May 2025 (actual)
- 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.
Behavioural Development, Long-term Outcomes and Opportunities to Optimize Youth Mental Health (BLOOM) is a project that aims to overcome age and diagnostic boundaries to generate person-specific longitudinal profiles of mental health in youth aged 9 to 25. The overarching objective is to lay the informational foundation to accurately predict both clinical outcomes and opportunities to optimize health trajectories. This project will recruit youth in need without any mental health diagnosis and follow them annually for 5 years. The present study includes assessment of antecedents, opportunities and outcomes that will establish eligibility for preventive interventions
Detailed description
We propose an accelerated longitudinal study design that allows covering a long developmental period (9 to 25 years) in a short study time (5 years follow-up). Youth and family caregivers will be recruited from various sources and followed-up annually for the first five years. Beyond this 5-year period, further follow-ups will depend on continued study funding and may be either annual or less frequent (e.g. every 3-4 years), and either interview-based or restricted to administrative data. The present study includes assessment of antecedents, opportunities and outcomes that will establish eligibility for preventive interventions; any randomised intervention studies based on this cohort will be based on the outcome for specific REB submissions in the future.
Predicting the onset of DMDs using a set of readily accessible antecedents
We hypothesise that youth who develop DMDs will have higher severity and frequency of antecedents compared to those who do not develop this outcome. We anticipate that a clinically meaningful prediction (i.e., with accuracy 80% or more said to be good or excellent, while less than 60% is deemed not meaningful; many existing predictors perform at 60-80% range9) of DMDs can be made with the set of readily measurable antecedents. We will estimate the strength of antecedent-outcome relationship separately in the two (help-seeking or non help-seeking) subgroups. While we expect variations in the rates of outcomes (help-seeking > non-help seeking), we hypothesise that the relationship between antecedents and DMDs will be similar across the groups with no major drop in the ability to predict outcome in any subgroup (i.e. >60% accuracy in each, below which prediction is unlikely to be of any clinical benefit59).
Relationship between predictive antecedents, resilience and biobehavioural markers
In the consenting subsample, we will assess if the polygenic risk of individual disorders/pathways and summary measures of brain health (age-appropriate structure, chemisty, function) differ between those who develop DMDs and those who do not. We will subsequently test if measures with highest effect size differences, if any, will improve the accuracy (discrimination index) for outcome prediction by at least 10% to assess their suitability for routine clinical implementation.
Of note, we propose this study as a part of a longer program whose first phase will be for 5 years duration. We anticipate following up this cohort for a longer period in phase 2, and embedding clinical trials in the cohort in future (not described here).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Help seeking group | – | –Primary care mental health service providers within the CIUSSS-ODIM catchment area will be the major referral source for this group. Youth and families referred to or self-referring for mental health needs to CLSCs at Dorval-Lachine-LaSalle, CLSC Pierrefonds/Lac-Saint-Louis, Social Paediatrics Clinics and Aire-Ouverte centres throughout the CIUSSS-West Island catchment will be approached by a member of these programmes to assess interest. A screening contact (on site or via telephone) by a member of the research team (who will work on site with clinical teams) will follow to review eligibility criteria. To increase uptake and reduce clinician burden, information leaflets and posters will be made available at the waiting rooms, webpages and social media sites of these youth programmes. |
| Non help seeking group | – | –Parents referral pathway: Youth will be recruited through their parents, patients of psychiatric clinics at the CIUSSS-ODIM. Parents will be approached by health professionals. A screening contact by a member of the research team will follow to review eligibility criteria. Other form of recruitment is non-profit organisations serving people living with mental illness, such as the Schizophrenia Society of Quebec as well as primary care practitioners caring for parents satisfying the eligibility criteria. Information leaflets and posters will be made available at the waiting rooms of these clinics and shared with the partner agencies. Social agencies referral pathway: Youth who have contacts with community agencies that provide various forms of social assistance will be recruited through printed and digital advertising. Direct contacts as well as referrals from agency workers and volunteers will be screened by a member of the research team. Physical health based referral pathway: Adv |
Who may qualify
- Ages
- 9 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Help-seeking group: Primary care mental health service providers within the CIUSSS-ODIM catchment area will be the major referral source for this group. Youth and families referred to or self-referring for mental health needs to CLSCs at Dorval-Lachine-LaSalle, CLSC Pierrefonds/Lac-Saint-Louis, Social Paediatrics Clinics and Aire-Ouverte centres throughout the CIUSSS-West Island catchment will be approached by a member of these programmes to assess interest. A screening contact (on site or via telephone) by a member of the research team (who will work on site with clinical teams) will follow to review eligibility criteria. To increase uptake and reduce clinician burden, information leaflets and posters will be made available at the waiting rooms, webpages and social media sites of these youth programmes (See the leaflet: Portraying Your Mental Health). Non help-seeking group: Parents referral pathway: For this group, youth will be recruited through their parents, who are current
Key inclusion criteria (5 listed)
- Youth between 9 to 25 years of age at inclusion, who are able to read and understand either French or English, with at least one parent or legal guardian available to consent for those under 18 years of age.
- Help-seeking group: At least one help-seeking contact made with a primary care clinical service provider or agency (e.g, paediatric/family physician clinic, CLSC or Aire Ouverte) for a mental health concern (i.e., clinical needs).
- At least one of the birth parents or siblings have received psychiatric care for a diagnosis of DMDs (i.e., family needs) OR Being in contact with community agencies that provide youth-centred social services for food, housing, social discrimination (e.g., racialized youth, LGBTQ2SIA+) (i.e., social needs) OR Having a diagnosed chronic physical illness that is expected to require treatment for >12 months (e.g., diabetes, asthma to name a few) (i.e., physical health needs)
Key exclusion criteria (2 listed)
- Due to the requirements of assessment procedures, youth who cannot communicate verbally due to known neurological conditions or intellectual disabilities will not be included. Youth who are already diagnosed with one of the DMDs by a physician and currently prescribed a treatment targeting the diagnosed condition (pharmacological or psychotherapeutic interventions), will not be eligible for inclusion.
- Importantly, no one will be excluded based on sex, gender, health insurance status, ethnicity, income status, ability to travel or living arrangements. If a participant initially approached through the referral pathways for non help-seeking individuals turns out to have had at least one help-seeking contact for a mental health concern (i.e., clinical needs), the participant will still be included but classified as part of the help-seeking group. We anticipate non help-seeking referrals to satisfy more than one criteria. Their occurrence and distribution will be recorded in detail as part of our assessment procedure.
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
Number of new onsets of one of the seven mental illnesses as per DSM-5 criteria
Time frame: From screening to 5 years of follow-up.
By applying a detailed diagnostic screen we will be able to capture all emerging mental illnesses as per the existing schedule of classification if present. But our primary outcome of interest (DMDs) is defined as a new onset of illnesses known to involve substantial functional impairment over multiple domains. These are moderate/severe major depressive disorder, bipolar disorder type I or type 2, schizoaffective disorder, schizophrenia, or schizophreniform disorder, anorexia and bulimia nervosa, OCD, moderate/severe ADHD, moderate or severe substance use disorder (SUD) all according to DSM-5 (as per DSM-5 Text Revision, updated September 2023). Notably, while epidemiological data indicates that features of some of these disorders (e.g. ADHD, OCD) begin at ages younger than 9, the mean age of diagnosis continues to be much later in practice.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
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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.
Centre intégré universitaire de santé et de services sociaux (CIUSSS) de l'Ouest-de-l'Île-de-Montréal
Montreal, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression - Major Depressive Disorder and Bipolar, run by Douglas Mental Health University Institute at 1 site 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 5 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of new onsets of one of the seven mental illnesses as per DSM-5 criteria (time frame: From screening to 5 years of follow-up.). 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 18 May 2025.