PsychosisEPS-12-25NCT04365621
The Clinical and Socio-demographic Characteristics of Young People Aged 12 to 25 Consulting on Ambulatory Structures in the Seine Saint-Denis
A study testing we enrolled ultra-high risk of psychosis (UHR) patient to describe in people with Psychosis, run by Januel at 5 sites in France.
Trial summary
A prospective study of the clinical and socio-demographic characteristics of young people aged 12 to 25 consulting on ambulatory structures in the Seine Saint-Denis. This research project, intersectoral and inter-institutional, built in a territorial logic, is therefore intended to study longitudinally over a year the… Read more about this study
- Who is it for?
- Ages 12 to 25 years
- Conditions the study is for
- Psychosis
- What is being tested?
- we enrolled ultra-high risk of psychosis (UHR) patient to describe
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 5 sitesFrance
- Study dates
- 10 Oct 2019to 2 May 2021
- Phase
- Interventional
- 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
- No healthy volunteers
- Child, Adult
Who may be able to join
- Boys and girls consulting in the structures involved in the study of the Seine-Saint-Denis department.
- Aged 12 to 25.
- Patients with an ultra high risk of psychosis.
- Affiliated with social security or with State Medical Aid (AME).
Who cannot join
- Subject with known neurological pathology
- Subject with insufficient knowledge of French
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites, 4 recruiting
- Recruiting
Relais Collégiens-Lycéens
La Courneuve, 93120
- Active, not recruiting
URC Ville Evrard
Neuilly-sur-Marne, 93330
- Recruiting
CASADO
Saint-Denis, 93200
- Recruiting
CMP Adulte Saint-Denis
Saint-Denis, 93200
Thibault ERNOUF, MBBS
Laurence STAMATIADIS, MBBS
- Recruiting
CMP Adulte Saint-Ouen
Saint-Ouen, 93400
About this study
A prospective study of the clinical and socio-demographic characteristics of young people aged 12 to 25 consulting on ambulatory structures in the Seine Saint-Denis.
This research project, intersectoral and inter-institutional, built in a territorial logic, is therefore intended to study longitudinally over a year the population of young consultants in the different units participating in it, to highlight their common profiles and differences.
This will be the first clinical research work concerning adolescents and young adults using mental health services in the Seine Saint Denis Ouest.
Read the detailed description
The main objective of the study will be to quantify the rate of subjects seeking help in our units meeting the criteria of subject with an ultra-high risk of psychosis (UHR).
Secondary objectives:
- Observe the transition rate of these high risk patients at one year.
- Study the socio-demographic and general psychopathology profiles of 12 - 25 year olds using the services of CMP, CASADO, mobile team and RCL.
- Monitor the development of school and professional integration, the overall functioning and self-esteem of subjects at six months and one year.
- Conditions
- Psychosis
- Being tested
- we enrolled ultra-high risk of psychosis (UHR) patient to describe
- Keywords
- psychiatry- mental illness-young population- ultra-high risk of psychosis
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
we enrolled ultra-high risk of psychosis (UHR) patient to describeOther
there is no intervention because we study only the prevalence of patients meeting UHR criteria
| Study group | Role | What they receive |
|---|---|---|
| ultra-high risk of psychosis patient | Other | patient with ultra -high risk of psychosis will be enrolled to the study Receives: Other: we enrolled ultra-high risk of psychosis (UHR) patient to describe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of ultra-high risk mental
Rate of subjects meeting the criteria for subjects with an ultra-high risk mental state after passing the CAARMS to M1.
Measured: "Month 1"
Rate of ultra-high risk mental
Rate of subjects meeting the criteria for subjects with an ultra-high risk mental state after passing the CAARMS to M12.
Measured: "Month12"
Secondary outcomes (12)
16-Item Version of the Prodromal Questionnaire (PQ-16)
developed to facilitate screening in subjects consulting in classical clinical practice of the risk of developing psychosis
Measured: J0
Rosenberg Scale
Chosen because brief (10 items),which can be supplemented by subjects from different age groups and backgrounds, without weighing down the clinical interview with the young subject.
Measured: "Month 1"
Rosenberg Scale
Chosen because brief (10 items),which can be supplemented by subjects from different age groups and backgrounds, without weighing down the clinical interview with the young subject.
Measured: "Month 6"
Rosenberg Scale
Chosen because brief (10 items),which can be supplemented by subjects from different age groups and backgrounds, without weighing down the clinical interview with the young subject.
Measured: "Month 12"
Adolescent Depression Rating Scale (ADRS)
10-item hetero questionnaire created specifically to assess depression in adolescence. The ADRS has demonstrated good validity and improved ability to discriminate against depressed and not depressed adolescents
Measured: Day 0
Adolescent Depression Rating Scale (ADRS)
10-item hetero questionnaire created specifically to assess depression in adolescence. The ADRS has demonstrated good validity and improved ability to discriminate against depressed and not depressed adolescents
Measured: Month 6
Adolescent Depression Rating Scale (ADRS)
10-item hetero questionnaire created specifically to assess depression in adolescence. The ADRS has demonstrated good validity and improved ability to discriminate against depressed and not depressed adolescents
Measured: Month 12
Social and Occupational Functionning Assessment Scale (SOFAS)
cited in the DSM-V to assess the V axis and overall functioning, ranging from 0 to 100 on a continuum ranging from "superior functioning in a large number of activities" to "inability to maintain minimal hygiene, inability to operate without significant outside assistance."
Measured: "Day 0"
Social and Occupational Functionning Assessment Scale (SOFAS)
cited in the DSM-V to assess the V axis and overall functioning, ranging from 0 to 100 on a continuum ranging from "superior functioning in a large number of activities" to "inability to maintain minimal hygiene, inability to operate without significant outside assistance."
Measured: "Month 6"
Social and Occupational Functionning Assessment Scale (SOFAS)
cited in the DSM-V to assess the V axis and overall functioning, ranging from 0 to 100 on a continuum ranging from "superior functioning in a large number of activities" to "inability to maintain minimal hygiene, inability to operate without significant outside assistance."
Measured: "Month12"
Comprehensive Assessment of At Risk Mental State (CAARMS)
A tool developed by Mc Gorry in 2005 to identify subjects at high risk of developing psychosis, track the evolution of their symptoms and set a symptomatic threshold for the actual transition to psychosis. It is recommended that its administration be reserved for "help seeking" subjects (Schultze-Lutter et al, 2015) and is accompanied by an overall operating quotation by SOFAS. It is divided into 7 scales, and makes it possible to identify 3 phenotypes of UHR subjects: vulnerable group
Measured: "Month1"
Comprehensive Assessment of At Risk Mental State (CAARMS)
A tool developed by Mc Gorry in 2005 to identify subjects at high risk of developing psychosis, track the evolution of their symptoms and set a symptomatic threshold for the actual transition to psychosis. It is recommended that its administration be reserved for "help seeking" subjects (Schultze-Lutter et al, 2015) and is accompanied by an overall operating quotation by SOFAS. It is divided into 7 scales, and makes it possible to identify 3 phenotypes of UHR subjects: vulnerable group
Measured: "Month 12"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start10 Oct 2019
- Primary completion2 May 2020 (estimated)
- Study completion2 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychosisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- It is a prospective study with a single group assignement.
- Masking
- None (open label)
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Januel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Januel, Centre hospitalier de Ville-Evrard, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04365621
- Sponsor's protocol ID
- 10477M-EPS-12-25-2020
- Acronym
- EPS-12-25
- Status last verified
- Apr 2020
- First submitted
- 16 Apr 2020
- Last updated
- 1 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical and Socio-demographic Characteristics of Young People Aged 12 to 25 Consulting on Ambulatory Structures in the Seine Saint-Denis
- ClinicalTrials.gov ID
- NCT04365621
- Acronym / sponsor ID
- EPS-12-25 / 10477M-EPS-12-25-2020
- Conditions
- Psychosis
- Keywords
- psychiatry- mental illness-young population- ultra-high risk of psychosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- JanuelUniversity, hospital or other
- Study start
- 10 Oct 2019 (actual)
- Primary completion
- 2 May 2020 (estimated)
- Study completion
- 2 May 2021 (estimated)
- First posted
- 28 Apr 2020 (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.
A prospective study of the clinical and socio-demographic characteristics of young people aged 12 to 25 consulting on ambulatory structures in the Seine Saint-Denis.
This research project, intersectoral and inter-institutional, built in a territorial logic, is therefore intended to study longitudinally over a year the population of young consultants in the different units participating in it, to highlight their common profiles and differences.
This will be the first clinical research work concerning adolescents and young adults using mental health services in the Seine Saint Denis Ouest.
Detailed description
The main objective of the study will be to quantify the rate of subjects seeking help in our units meeting the criteria of subject with an ultra-high risk of psychosis (UHR).
Secondary objectives:
- Observe the transition rate of these high risk patients at one year.
- Study the socio-demographic and general psychopathology profiles of 12 - 25 year olds using the services of CMP, CASADO, mobile team and RCL.
- Monitor the development of school and professional integration, the overall functioning and self-esteem of subjects at six months and one year.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- It is a prospective study with a single group assignement.
| Arm | Type | Receives |
|---|---|---|
| ultra-high risk of psychosis patient | Other | Other: we enrolled ultra-high risk of psychosis (UHR) patient to describepatient with ultra -high risk of psychosis will be enrolled to the study |
Who may qualify
- Ages
- 12 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Boys and girls consulting in the structures involved in the study of the Seine-Saint-Denis department.
- Aged 12 to 25.
- Patients with an ultra high risk of psychosis.
- Affiliated with social security or with State Medical Aid (AME).
Key exclusion criteria (2 listed)
- Subject with known neurological pathology
- Subject with insufficient knowledge of French
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| we enrolled ultra-high risk of psychosis (UHR) patient to describethere is no intervention because we study only the prevalence of patients meeting UHR criteria | Other | ultra-high risk of psychosis patient |
Primary outcome
Rate of ultra-high risk mental
Time frame: "Month 1"
Rate of subjects meeting the criteria for subjects with an ultra-high risk mental state after passing the CAARMS to M1.
Rate of ultra-high risk mental
Time frame: "Month12"
Rate of subjects meeting the criteria for subjects with an ultra-high risk mental state after passing the CAARMS to M12.
12 secondary outcomes
16-Item Version of the Prodromal Questionnaire (PQ-16)
Time frame: J0
Rosenberg Scale
Time frame: "Month 1"
Rosenberg Scale
Time frame: "Month 6"
Rosenberg Scale
Time frame: "Month 12"
Adolescent Depression Rating Scale (ADRS)
Time frame: Day 0
Adolescent Depression Rating Scale (ADRS)
Time frame: Month 6
Adolescent Depression Rating Scale (ADRS)
Time frame: Month 12
Social and Occupational Functionning Assessment Scale (SOFAS)
Time frame: "Day 0"
Social and Occupational Functionning Assessment Scale (SOFAS)
Time frame: "Month 6"
Social and Occupational Functionning Assessment Scale (SOFAS)
Time frame: "Month12"
Comprehensive Assessment of At Risk Mental State (CAARMS)
Time frame: "Month1"
Comprehensive Assessment of At Risk Mental State (CAARMS)
Time frame: "Month 12"
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2020.
- Individual participant dataSharing planned: No
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing we enrolled ultra-high risk of psychosis (UHR) patient to describe in people with Psychosis, run by Januel at 5 sites in France.
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 4 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: status not confirmed, as of the sponsor's last update on 1 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rusheenthira THAVASEELAN, Msc (0143093232, r.thavaseelan@epsve.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of ultra-high risk mental (time frame: "Month 1"). The study lists 2 primary outcomes in all. 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 1 May 2020.