Exploring Psychosis in Children and Adolescents

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the spectrum of schizophrenia and related psychotic disorders in children and adolescents across five sites in France. It involves comprehensive assessments including diagnostic interviews, cognitive evaluations, neuroimaging, and genetic analyses to understand the clinical subgroups and their responses to antipsychotic medications. Patients with at least one psychotic episode will be included, and their treatment responses will be monitored over a period of up to five years. The goal is to clarify the relationship between developmental profiles and treatment outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• Pitié Salpétrière
  Paris, France Recruiting
• Fondation Vallée, Gentilly
  Gentilly, France Not yet recruiting
• CHRU de Lille
  Lille, France Not yet recruiting
• CHU de Nice
  Nice, France Not yet recruiting
• CHU de Rouen
  Rouen, France Not yet recruiting
• CHU de Rouvray
  Rouen, France Not yet recruiting

Study contacts

• Study coordinator: Claudine LAURENT-LEVINSON, M.D., Ph.D.
• Email: claudine.laurent@aphp.fr
• Phone: 1 42 16 23 44

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.