Dimensional and Developmental Profiles of Psychosis in Children and Adolescents

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

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 Criteria

Inclusion

Inclusion Criteria for the Patient:

  1. Children and young adults ages 7-20 years with age of onset of psychotic disorderbetween 7-17 years.
  2. Hospitalized or seen for out-patient treatment for a psychotic episode, acute orchronic.
  3. DSM-V diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder,brief psychotic disorder, psychotic disorder not otherwise specified, or majordepressive episode with psychotic features.
  4. Written informed consent signed by the parents or the individual(s) with legalparental 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 clinicalstabilization (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 ofthe study :
  7. Parents : no specific criteria.
  8. Siblings : siblings are eligible to participate if there are at least two first-degreerelatives with psychotic disorders (including the patient) in the family.
  9. Written informed consent for the genetic part of the study signed by any participatingparents and siblings.
  10. Has health insurance coverage from Social Security (France) (not AME coverage).

Exclusion

Exclusion Criteria:

  1. Moderate or severe intellectual deficiency (IQ < 50).
  2. Psychoses judged to be secondary to medical illness, medication effects or drugs ofabuse.
  3. Diagnosis of bipolar disorder.
  4. Patients who are under legal guardianship.
  5. 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

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 analyzed to clarify whether there is a different response to antipsychotic treatment based on developmental and clinical expression.To answer the question asked in the research, it is planned to include people with at least one psychotic episode,The target population will be a prospective cohort of patients admitted to a hospital or psychiatric clinic for the treatment of psychotic symptoms.Comprehensive medical evaluation will be carried out according to the clinical features and medical history of each patient, to identify medical causes of psychosis. Comprehensive neuropsychological and speech / language evaluation will be completed. A child psychiatrist-diagnostician will complete the Lifetime Dimensions of Psychosis Scale - Child and Adolescent version at baseline. When the patient and parents agree, structural and functional MRI examinations will also be completed, and blood will be drawn for DNA extraction and analysis. Selected assessments (including evaluation of treatment response to specific antipsychotic drugs) will be performed at follow-up visits after 1, 3 and 5 years.

Connect with a study center

  • Fondation Vallée, Gentilly

    Gentilly, 94257
    France

    Site Not Available

  • CHRU de Lille

    Lille, 59037
    France

    Site Not Available

  • CHU de Nice

    Nice, 62000
    France

    Site Not Available

  • Pitié Salpétrière

    Paris, 75013
    France

    Active - Recruiting

  • CHU de Rouen

    Rouen, 76031
    France

    Site Not Available

  • CHU de Rouvray

    Rouen, 76031
    France

    Site Not Available

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