NCT01512641

Brief Summary

Schizophrenia beginning before 18 years is a clinical entity not well known because of its low incidence and difficulties in the clinical diagnosis. However, in the investigators clinical practice, due to the specialization of the investigators service, the investigators are led to hospital to receive important feel active of patients meeting the Diagnostic and Statistical Manual of Mental Disorders IV text revision (DSM IV-TR) precose schizophrenia. The work of us team on the theme of the relationship between Pervasive Developmental Disorders and precose Schizophrenia led us to hypothesize that a number of children in care in the medical and educational institutes, hospitals and day shelters therapeutic part-time symptoms of schizophrenia or a line real early diagnosis of schizophrenia undervalued or not diagnosed. The main goal is to estimate the prevalence of dissociative disorders in a population of children in care institutions and medical education in child psychiatry in hospitals and others structures.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
301

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2011

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

December 13, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 19, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

February 3, 2014

Status Verified

January 1, 2014

Enrollment Period

1.4 years

First QC Date

December 13, 2011

Last Update Submit

January 31, 2014

Conditions

Keywords

children dissociative disorders schizophrenia

Outcome Measures

Primary Outcomes (1)

  • Rate of children diagnosed with dissociative disorders

    Rate of children diagnosed with dissociative disorders: children positive for the test Kiddie-Schedule for Affective Disorders and Schizophrenia (Kiddie-SADS).

    between 2 and 4 hours depending children

Secondary Outcomes (5)

  • Percentage of children positive for test: Autism Diagnostic Interview-Revise (ADI-R).

    1 day on average

  • Scores of three dimensions of schizophrenia in the Positive And Negative Syndrome Scale (PANSS)

    4 hours

  • Score at the Test Lillois de Communication (TLC)

    30 minutes

  • Score on the Wechsler Intelligence Scale for Children-Fourth Edition (WISC IV)subtests and overall intelligence quotient (IQ).

    4 hours

  • Response time to test verbal fluency, scores on the Trail Making Test A (TMT) and TMT B.

    30 minutes

Study Arms (1)

Children with Dissociative Disorders

EXPERIMENTAL

Children will take first the primary stage. If one child is positive, he will pass the secondary stage.

Other: Primary stageOther: Secondary stage

Interventions

Kiddie-Schedule for Affective Disorders and Schizophrenia

Children with Dissociative Disorders

children who are positive to the kiddie-SADS (primary stage), will take the tests: PANSS, Scale for the Assessment of Negative Symptoms (SANS), ADI-R, scale TLC and WISC IV

Children with Dissociative Disorders

Eligibility Criteria

Age7 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • to 18 years
  • Supported in the partner institutions of the study
  • IQ\>35 on the certificate of orientation of the Maison Départementale des Personnes Handicapées (MDPH)
  • Obtaining the agreement of parents and children

You may not qualify if:

  • QI\<35 on the certificate file Guidance MDPH
  • Children not speaking french

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Psychiatrie infanto-juvénile - Centre Hospitalier d'Antibes

Antibes, 06600, France

Location

Psychiatrie infanto-juvénile-Pôle femme-mère -enfant

Fréjus, 83608, France

Location

Service de psychiatrie de l'enfant et de l'adolescent

Marseille, 13009, France

Location

Service de psychiatrie de l'enfant et de l'adolescent

Nice, 06000, France

Location

Related Publications (1)

  • Dor-Nedonsel E, Menard ML, Fernandez A, Sakarovitch C, Fontas E, Salle-Collemiche X, Poinso F, Tosello AL, Maria F, Manera V, Askenazy F, Thummler S. Early-Onset Schizophrenia in a paediatric population of French psychiatric and medico-social care centres: A cross sectional study. PLoS One. 2020 Jul 27;15(7):e0236241. doi: 10.1371/journal.pone.0236241. eCollection 2020.

MeSH Terms

Conditions

Dissociative DisordersSchizophrenia

Condition Hierarchy (Ancestors)

Mental DisordersSchizophrenia Spectrum and Other Psychotic Disorders

Study Officials

  • Florence ASKENAZY, PU-PH

    University hospital of Nice

    STUDY DIRECTOR
  • Emmanuelle DOR, PH

    University hospital of Nice

    PRINCIPAL INVESTIGATOR
  • François POINSO, PU-PH

    AP-HM

    PRINCIPAL INVESTIGATOR
  • Michèle BATTISTA, PH

    Frejus's hospital

    PRINCIPAL INVESTIGATOR
  • Michel BOUBLIL, PH

    Antibes's hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2011

First Posted

January 19, 2012

Study Start

December 1, 2011

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

February 3, 2014

Record last verified: 2014-01

Locations