The Clinical and Socio-demographic Characteristics of Young People Aged 12 to 25 Consulting on Ambulatory Structures in the Seine Saint-Denis

Psychosis Clinical Trial

— EPS-12-25  

Official title:

The Clinical and Socio-demographic Characteristics of Young People Aged 12 to 25 Consulting on Ambulatory Structures in the Seine Saint-Denis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04365621
• Other study ID #: 10477M-EPS-12-25-2020
• Status: Recruiting
• Phase: N/A
• Start date: October 10, 2019
• Est. completion date: May 2, 2021

Study information

• Verified date: April 2020
• Source: Centre hospitalier de Ville-Evrard, France
• Contact: Rusheenthira THAVASEELAN, Msc
• Phone: 0143093232
• Email: r.thavaseelan[@]epsve.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: May 2, 2021
• Est. primary completion date: May 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 25 Years

Eligibility

Inclusion Criteria:

• 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).

Exclusion Criteria:

• Subject with known neurological pathology

• Subject with insufficient knowledge of French

Related Conditions & MeSH terms

• Mental Disorders
• Psychosis
• Psychotic Disorders

Intervention

Other:
• we enrolled ultra-high risk of psychosis (UHR) patient to describe
there is no intervention because we study only the prevalence of patients meeting UHR criteria

Locations

Country	Name	City	State
France	Relais Collégiens-Lycéens	La Courneuve
France	URC Ville Evrard	Neuilly-sur-Marne
France	CASADO	Saint-Denis
France	CMP Adulte Saint-Denis	Saint-Denis
France	CMP Adulte Saint-Ouen	Saint-Ouen

Sponsors (1)

Lead Sponsor	Collaborator
Januel

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	"Month 1"
Primary	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.	"Month12"
Secondary	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	J0
Secondary	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.	"Month 1"
Secondary	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.	"Month 6"
Secondary	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.	"Month 12"
Secondary	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	Day 0
Secondary	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	Month 6
Secondary	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	Month 12
Secondary	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."	"Day 0"
Secondary	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."	"Month 6"
Secondary	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."	"Month12"
Secondary	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	"Month1"
Secondary	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	"Month 12"