Dimensional and Developmental Profiles of Psychosis in Children and Adolescents (PSYDEV)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Psychotic Disorders; Schizophrenia
• Intervention / Treatment: Other: clinical, neuroimaging and DNA assessments

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 Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Claudine LAURENT-LEVINSON, M.D., Ph.D.; Phone Number: +33 1 42 16 23 44; Email: claudine.laurent@aphp.fr
• Study Contact Backup: Name: Anne BISSERY; Phone Number: +33 1 42 16 34 32; Email: anne.bissery@aphp.fr

Study Locations

• France
  • Gentilly, France, 94257
    • Not yet recruiting
    • Fondation Vallée, Gentilly
    • Contact: BISSERY Anne; Phone Number: 01 42 16 24 32; Email: anne.bissery@aphp.fr
    • Principal Investigator: JOUSSELME Catherine
  • Lille, France, 59037
    • Not yet recruiting
    • CHRU de Lille
    • Contact: BISSERY Anne; Phone Number: 01 42 16 24 32; Email: anne.bissery@aphp.fr
    • Principal Investigator: JARDRI Renaud
  • Nice, France, 62000
    • Not yet recruiting
    • CHU de Nice
    • Contact: BISSERY Anne; Phone Number: 01 42 16 24 32; Email: anne.bissery@aphp.fr
    • Principal Investigator: ASKENAZY Florence
  • Paris, France, 75013
    • Recruiting
    • Pitie Salpetriere
    • Contact: BISSERY Anne; Phone Number: 01 42 16 24 32; Email: anne.bissery@aphp.fr
    • Principal Investigator: LAURENT-LEVINSON Claudine, M.D., Ph.D.
  • Rouen, France, 76031
    • Not yet recruiting
    • CHU de Rouen
    • Contact: BISSERY Anne; Phone Number: 01 42 16 24 32; Email: anne.bissery@aphp.fr
    • Principal Investigator: GERARDIN Priscile
  • Rouen, France, 76031
    • Not yet recruiting
    • CHU de Rouvray
    • Contact: BISSERY Anne; Phone Number: 01 42 16 24 32; Email: anne.bissery@aphp.fr
    • Principal Investigator: GERARDIN Priscile

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 20 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: prospective cohort; prospective monitoring of children and adolescents with schizophrenia and related psychotic disorders	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lifetime Dimensions of Psychosis Scale-Child and Adolescent Version	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.	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical global impressions scale - change version	score on a 7 point scale ; worse is 7	at 5 years
Cortical gray matter volume (Magnetic Resonance Imaging)	Statistical differences among the four clinical clusters in the summary measure of cortical gray matter volume	up to 4 months
Stability of clinical profile on Lifetime Dimensions of Psychosis Scale-Child and Adolescent Version	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	at 5 years

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Study Director: Claudine LAURENT-LEVINSON, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2021
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: March 25, 2020
• First Submitted That Met QC Criteria: April 28, 2020
• First Posted (Actual): May 1, 2020

Study Record Updates

• Last Update Posted (Actual): January 9, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: magnetic resonance imaging; cognition; schizophrenia; psychosis; treatment response; early-onset; schizophrenia spectrum; course of illness
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Psychotic Disorders; Mental Disorders
• Other Study ID Numbers: K160906J; 2018-A01072-53 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No