NCT04370730

Dimensional and Developmental Profiles of Psychosis in Children and Adolescents

Dimensional and Developmental Approach to Psychotic Episodes in Children and Adolescents: Impact on Clinical Management

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 7 Years – 20 Years
• Healthy volunteers: Accepted

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.

Conditions

• Schizophrenia
• Psychotic Disorders

Interventions

Type	Name	Description
OTHER	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

Timeline

• Start date: 2021-06-02
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2020-05-01
• Last updated: 2026-01-23

Locations

6 sites across 1 country: France