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Clinical Trials/NCT04365621
NCT04365621
Unknown
N/A

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

Januel5 sites in 1 country900 target enrollmentOctober 10, 2019
ConditionsPsychosis

Overview

Phase
N/A
Intervention
Not specified
Conditions
Psychosis
Sponsor
Januel
Enrollment
900
Locations
5
Primary Endpoint
Rate of ultra-high risk mental
Last Updated
6 years ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
October 10, 2019
End Date
May 2, 2021
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Januel
Responsible Party
Sponsor Investigator
Principal Investigator

Januel

Psychiatrist, head of the clinical research department

Centre hospitalier de Ville-Evrard, France

Eligibility Criteria

Inclusion Criteria

  • Boys and girls consulting in the structures involved in the study of the Seine-Saint-Denis department.
  • Aged 12 to
  • 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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • 16-Item Version of the Prodromal Questionnaire (PQ-16)(J0)
  • Rosenberg Scale("Month 12")
  • Adolescent Depression Rating Scale (ADRS)(Month 12)
  • Social and Occupational Functionning Assessment Scale (SOFAS)("Month12")
  • Comprehensive Assessment of At Risk Mental State (CAARMS)("Month 12")

Study Sites (5)

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