Last updated: January 8, 2024
Sponsor: Assistance Publique - Hôpitaux de Paris
Overall Status: Active - Recruiting
Phase
N/A
Condition
Schizophrenia And Schizoaffective Disorders (Pediatric)
Schizotypal Personality Disorder (Spd)
Tourette's Syndrome
Treatment
clinical, neuroimaging and DNA assessments
Clinical Study ID
NCT04370730
K160906J
2018-A01072-53
Ages 7-20 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria for the Patient:
- Children and young adults ages 7-20 years with age of onset of psychotic disorderbetween 7-17 years.
- Hospitalized or seen for out-patient treatment for a psychotic episode, acute orchronic.
- DSM-V diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder,brief psychotic disorder, psychotic disorder not otherwise specified, or majordepressive episode with psychotic features.
- Written informed consent signed by the parents or the individual(s) with legalparental authority, and by the minor patient if his/her condition permits.
- Written informed consent signed by the patient if he/she is a major, after clinicalstabilization (not delusional).
- Has health insurance coverage from Social Security (France) (not AME coverage). Inclusion Criteria for parents or siblings wishing to participate in the genetic part ofthe study :
- Parents : no specific criteria.
- Siblings : siblings are eligible to participate if there are at least two first-degreerelatives with psychotic disorders (including the patient) in the family.
- Written informed consent for the genetic part of the study signed by any participatingparents and siblings.
- Has health insurance coverage from Social Security (France) (not AME coverage).
Exclusion
Exclusion Criteria:
- Moderate or severe intellectual deficiency (IQ < 50).
- Psychoses judged to be secondary to medical illness, medication effects or drugs ofabuse.
- Diagnosis of bipolar disorder.
- Patients who are under legal guardianship.
- For the neuroimaging part of the study only : any contraindications to MagneticResonance Imaging.
Study Design
Total Participants: 200
Treatment Group(s): 1
Primary Treatment: clinical, neuroimaging and DNA assessments
Phase:
Study Start date:
June 02, 2021
Estimated Completion Date:
October 01, 2026
Study Description
Connect with a study center
Fondation Vallée, Gentilly
Gentilly, 94257
FranceSite Not Available
CHRU de Lille
Lille, 59037
FranceSite Not Available
CHU de Nice
Nice, 62000
FranceSite Not Available
Pitié Salpétrière
Paris, 75013
FranceActive - Recruiting
CHU de Rouen
Rouen, 76031
FranceSite Not Available
CHU de Rouvray
Rouen, 76031
FranceSite Not Available
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