Dimensional and Developmental Profiles of Psychosis in Children and Adolescents

NCT04370730 | Recruiting

• 2 other identifiers: K160906J2018-A01072-53
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 6

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.

Conditions

Schizophrenia; Psychotic Disorders

Keywords

schizophrenia; schizophrenia spectrum; psychosis; early-onset; cognition; magnetic resonance imaging; course of illness; treatment response

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Clinical global impressions scale - change version

  at 5 years

• Cortical gray matter volume (Magnetic Resonance Imaging)

  up to 4 months

• Stability of clinical profile on Lifetime Dimensions of Psychosis Scale-Child and Adolescent Version

  at 5 years

Study Arms (1)

prospective cohort

OTHER

prospective monitoring of children and adolescents with schizophrenia and related psychotic disorders

Other: clinical, neuroimaging and DNA assessments

Interventions

clinical, neuroimaging and DNA assessments OTHER

Selected assessments, including evaluation of treatment response to specific antipsychotic drugs, will be performed at follow-up visits after 1, 3 and 5 years

prospective cohort

Eligibility Criteria

• Age: 7 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children and young adults ages 7-20 years with age of onset of psychotic disorder between 7-17 years.
• Hospitalized or seen for out-patient treatment for a psychotic episode, acute or chronic.
• DSM-V diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, psychotic disorder not otherwise specified, or major depressive episode with psychotic features.
• 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.
• Written informed consent signed by the patient if he/she is a major, after clinical stabilization (not delusional).
• Has health insurance coverage from Social Security (France) (not AME coverage).
• Parents : no specific criteria.
• Siblings : siblings are eligible to participate if there are at least two first-degree relatives with psychotic disorders (including the patient) in the family.
• Written informed consent for the genetic part of the study signed by any participating parents and siblings.
• Has health insurance coverage from Social Security (France) (not AME coverage).

You may not qualify if:

• Moderate or severe intellectual deficiency (IQ \< 50).
• Psychoses judged to be secondary to medical illness, medication effects or drugs of abuse.
• Diagnosis of bipolar disorder.
• Patients who are under legal guardianship.
• For the neuroimaging part of the study only : any contraindications to Magnetic Resonance Imaging.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (6)

Fondation Vallée, Gentilly

Gentilly, 94257, France

NOT YET RECRUITING

CHRU de Lille

Lille, 59037, France

NOT YET RECRUITING

CHU de Nice

Nice, 62000, France

NOT YET RECRUITING

Pitié Salpétrière

Paris, 75013, France

RECRUITING

CHU de Rouen

Rouen, 76031, France

NOT YET RECRUITING

CHU de Rouvray

Rouen, 76031, France

NOT YET RECRUITING

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Disease Progression

Interventions

Neuroimaging

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Neurological; Investigative Techniques

Study Officials

• Claudine LAURENT-LEVINSON

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Central Study Contacts

Claudine LAURENT-LEVINSON, M.D., Ph.D.

CONTACT

1 42 16 23 44; claudine.laurent@aphp.fr

Anne BISSERY

CONTACT

1 42 16 34 32; anne.bissery@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective cohort study

Study Record Dates

• First Submitted: March 25, 2020
• First Posted: May 1, 2020
• Study Start: June 2, 2021
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: January 23, 2026

Record last verified: 2025-01

Locations

FR (6)