Actively Recruiting

Phase Not Applicable
Age: 7Years - 20Years
All Genders
Healthy Volunteers
ID04370730

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

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-01-23

200

Participants Needed

6

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying the wide range of schizophrenia and related psychotic disorders in children and adolescents aged 7 to 20 years. The study aims to identify clinical subgroups within this population and determine if these groups predict how patients respond to specific antipsychotic medications. This research involves collaboration across five sites in France and includes both clinical and biological data collection to better understand these conditions. The study involves comprehensive assessments including diagnostic interviews, developmental histories, cognitive testing, neuroimaging (MRI), and DNA analyses when patients and families agree. Participants will be monitored over time with follow-up visits scheduled at 1, 3, and 5 years to evaluate treatment responses and changes in clinical and cognitive status. These assessments include evaluating the Lifetime Dimensions of Psychosis Scale in children and adolescents. Participants will undergo medical and neuropsychological evaluations, speech and language assessments, and complete questionnaires related to psychosis symptoms. MRI scans and blood samples for genetic testing may be collected if consented. Researchers will track clinical changes, cognitive function, and treatment effects using specific scales during follow-up. The main outcome measured is the Lifetime Dimensions of Psychosis Scale at 4 months, with additional long-term evaluations up to 5 years. The total duration of participation spans several years with periodic assessments.

CONDITIONS

Brief Title

Dimensional and Developmental Profiles of Psychosis in Children and Adolescents

Who Can Participate

Age: 7Years - 20Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Children and young adults aged 7 to 20 years with onset of psychotic disorder between 7 and 17 years
  • Hospitalized or receiving outpatient treatment for an acute or chronic psychotic episode
  • Diagnosed with schizophrenia, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, psychotic disorder not otherwise specified, or major depressive episode with psychotic features according to DSM-V
  • Written informed consent signed by parents or legal guardians and by the minor patient if possible
  • Written informed consent signed by the patient if of legal age after clinical stabilization
  • Health insurance coverage from Social Security (France), not AME coverage
  • For genetic study participation, siblings must have at least two first-degree relatives with psychotic disorders in the family
  • Written informed consent for genetic part signed by participating parents and siblings
  • Health insurance coverage from Social Security (France) for genetic study participants, not AME coverage
Not Eligible

You will not qualify if you...

  • Moderate or severe intellectual disability (IQ less than 50)
  • Psychoses caused by medical illness, medication effects, or substance abuse
  • Diagnosis of bipolar disorder
  • Patients under legal guardianship
  • For neuroimaging only: any contraindications to MRI scanning

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Baseline Assessments

Duration - Up to 4 months

Participants undergo comprehensive medical, neuropsychological, and speech/language evaluations. A child psychiatrist completes the Lifetime Dimensions of Psychosis Scale - Child and Adolescent version. When agreed, MRI scans and blood samples for DNA analysis are collected.

1 baseline visit with possible MRI and blood draw

Long-term Monitoring

Duration - 5 years

Participants are monitored through follow-up visits to assess clinical response and treatment effects, including evaluation of treatment response to specific antipsychotic drugs.

Follow-up visits at 1, 3, and 5 years

Trial Site Locations

Total: 6 locations

1

Fondation Vallée, Gentilly

Gentilly, France, 94257

Not Yet Recruiting

2

CHRU de Lille

Lille, France, 59037

Not Yet Recruiting

3

CHU de Nice

Nice, France, 62000

Not Yet Recruiting

4

Pitié Salpétrière

Paris, France, 75013

Actively Recruiting

5

CHU de Rouen

Rouen, France, 76031

Not Yet Recruiting

6

CHU de Rouvray

Rouen, France, 76031

Not Yet Recruiting

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Research Team

C

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

A

Anne BISSERY

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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