Dimensional and Developmental Profiles of Psychosis in Children and Adolescents

Not Applicable

Recruiting

• Conditions: Psychotic Disorders; Schizophrenia
• Interventions: Other: clinical, neuroimaging and DNA assessments

• Registration Number: NCT04370730
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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 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.

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 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.

Study Timeline

• Study First Submitted: 2020-03-25
• Study First Submitted QC: 2020-04-28
• Study First Posted: 2020-05-01
• Study Start: 2021-06-02
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-08
• Last Update Posted: 2024-01-09
• Primary Completion: 2026-10-01
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
prospective cohort	clinical, neuroimaging and DNA assessments	prospective monitoring of children and adolescents with schizophrenia and related psychotic disorders

Primary Outcome Measures

Name	Time	Method
Lifetime Dimensions of Psychosis Scale-Child and Adolescent Version	4 months	Symptoms are rated for lifetime duration and for severity during the worst two-week period.; Number of participants assigned to each of four clinical clusters derived by cluster analysis from clinical and developmental ratings on this scale as previously described.

Secondary Outcome Measures

Name	Time	Method
Clinical global impressions scale - change version	at 5 years	score on a 7 point scale ; worse is 7
Cortical gray matter volume (Magnetic Resonance Imaging)	up to 4 months	Statistical differences among the four clinical clusters in the summary measure of cortical gray matter volume
Stability of clinical profile on Lifetime Dimensions of Psychosis Scale-Child and Adolescent Version	at 5 years	differences among the four clinical clusters over time, comparing the cluster assignment at the time of stabilization to the assignment at the last study visit

Trial Locations

Locations (6)

CHU de Rouvray; 🇫🇷 Rouen, France

CHRU de Lille; 🇫🇷 Lille, France

CHU de Nice; 🇫🇷 Nice, France

CHU de Rouen; 🇫🇷 Rouen, France

Fondation Vallée, Gentilly; 🇫🇷 Gentilly, France

Pitié Salpétrière; 🇫🇷 Paris, France