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Clinical Trials in France / NCT04370730
Recruiting Not applicable

Dimensional and Developmental Profiles of Psychosis in Children and Adolescents

NCT04370730 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2021-06-02
Last updated
2026-01-23

Condition(s) studied

SchizophreniaPsychotic Disorders

Investigational drug(s) / intervention(s)

clinical, neuroimaging and DNA assessments

clinical, neuroimaging and DNA assessments: Selected assessments, including evaluation of treatment response to specific antipsychotic drugs, will be performed at follow-up visits after 1, 3 and 5 years

Study 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 clinical ratings, comprehensive cognitive assessments, neuroimaging and DNA (copy number variant) analyses (in families and patients who agree), and follow-up of course of illness, cognitive status and treatment response to specific antipsychotic drugs. The goal of the study is to test a prior hypothesis about clinical subgroups in this population and to test whether these subgroups predict antipsychotic medication response.

Eligibility

Sex
ALL
Min age
7 Years
Max age
20 Years
Healthy volunteers
Accepted
Inclusion Criteria for the Patient: 1. Children and young adults ages 7-20 years with age of onset of psychotic disorder between 7-17 years. 2. Hospitalized or seen for out-patient treatment for a psychotic episode, acute or chronic. 3. DSM-V diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, psychotic disorder not otherwise specified, or major depressive episode with psychotic features. 4. 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. 5. Written informed consent signed by the patient if he/she is a major, after clinical stabilization (not delusional). 6. 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 : 1. Parents : no specific criteria. 2. Siblings : siblings are eligible to participate if there are at least two first-degree relatives with psychotic disorders (including the patient) in the family. 3. Written informed consent for the genetic part of the study signed by any participating parents and siblings. 4. Has health insurance coverage from Social Security (France) (not AME coverage). Exclusion Criteria: 1. Moderate or severe intellectual deficiency (IQ \< 50). 2. Psychoses judged to be secondary to medical illness, medication effects or drugs of abuse. 3. Diagnosis of bipolar disorder. 4. Patients who are under legal guardianship. 5. For the neuroimaging part of the study only : any contraindications to Magnetic Resonance Imaging.

Primary outcome measure(s)

Trial sites (6)

FacilityCityRegionStatus
Fondation Vallée, Gentilly Gentilly France Not Yet Recruiting
CHRU de Lille Lille France Not Yet Recruiting
CHU de Nice Nice France Not Yet Recruiting
Pitié Salpétrière Paris France Recruiting
CHU de Rouen Rouen France Not Yet Recruiting
CHU de Rouvray Rouen France Not Yet Recruiting

More Assistance Publique - Hôpitaux de Paris trials in France

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04370730 on ClinicalTrials.gov ↗ ← All trials in France