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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01512641
Other study ID # 11-API-01
Secondary ID
Status Completed
Phase N/A
First received December 13, 2011
Last updated January 31, 2014
Start date December 2011
Est. completion date May 2013

Study information

Verified date January 2014
Source Centre Hospitalier Universitaire de Nice
Contact n/a
Is FDA regulated No
Health authority France: Committee for the Protection of PersonnesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 301
Est. completion date May 2013
Est. primary completion date May 2013
Accepts healthy volunteers No
Gender Both
Age group 7 Years to 18 Years
Eligibility Inclusion Criteria:

- 7 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

Exclusion Criteria:

- QI<35 on the certificate file Guidance MDPH

- Children not speaking french

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Other:
Primary stage
Kiddie-Schedule for Affective Disorders and Schizophrenia
Secondary stage
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

Locations

Country Name City State
France Psychiatrie infanto-juvénile - Centre Hospitalier d'Antibes Antibes
France Psychiatrie infanto-juvénile-Pôle femme-mère -enfant Fréjus
France Service de psychiatrie de l'enfant et de l'adolescent Marseille
France Service de psychiatrie de l'enfant et de l'adolescent Nice

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Percentage of children positive for test: Autism Diagnostic Interview-Revise (ADI-R). 1 day on average No
Secondary Scores of three dimensions of schizophrenia in the Positive And Negative Syndrome Scale (PANSS) 3 dimensions: positive symptoms, negative symptoms and general psychopathology, based on these scores the diagnostic subtype of schizophrenia is established. 4 hours No
Secondary Score at the Test Lillois de Communication (TLC) 30 minutes No
Secondary Score on the Wechsler Intelligence Scale for Children-Fourth Edition (WISC IV)subtests and overall intelligence quotient (IQ). 4 hours No
Secondary Response time to test verbal fluency, scores on the Trail Making Test A (TMT) and TMT B. 30 minutes No
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