Status:
RECRUITING
Dimensional and Developmental Profiles of Psychosis in Children and Adolescents
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Schizophrenia
Psychotic Disorders
Eligibility:
All Genders
7-20 years
Phase:
NA
Brief Summary
Five collaborating sites in France will study the broad spectrum of schizophrenia in children and adolescents. Patients will be studied with diagnostic interviews, developmental histories, dimensional...
Detailed Description
This study relates to the organization of a collection of clinical, biological / genetic and radiological (MRI) data from people with a psychotic episode and from their families. These data will be an...
Eligibility Criteria
Inclusion
- Inclusion Criteria for the Patient:
- Children and young adults ages 7-20 years with age of onset of psychotic disorder between 7-17 years.
- Hospitalized or seen for out-patient treatment for a psychotic episode, acute or chronic.
- DSM-V diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, psychotic disorder not otherwise specified, or major depressive episode with psychotic features.
- Written informed consent signed by the parents or the individual(s) with legal parental 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 clinical stabilization (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 of the study :
- Parents : no specific criteria.
- Siblings : siblings are eligible to participate if there are at least two first-degree relatives with psychotic disorders (including the patient) in the family.
- Written informed consent for the genetic part of the study signed by any participating parents and siblings.
- Has health insurance coverage from Social Security (France) (not AME coverage).
- Exclusion Criteria:
- Moderate or severe intellectual deficiency (IQ \< 50).
- Psychoses judged to be secondary to medical illness, medication effects or drugs of abuse.
- Diagnosis of bipolar disorder.
- Patients who are under legal guardianship.
- For the neuroimaging part of the study only : any contraindications to Magnetic Resonance Imaging.
Exclusion
Key Trial Info
Start Date :
June 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04370730
Start Date
June 2 2021
End Date
October 1 2026
Last Update
January 9 2024
Active Locations (6)
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1
Fondation Vallée, Gentilly
Gentilly, France, 94257
2
CHRU de Lille
Lille, France, 59037
3
CHU de Nice
Nice, France, 62000
4
Pitié Salpétrière
Paris, France, 75013