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

January 21, 2026 updated by: Assistance Publique - Hôpitaux de Paris

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Gentilly, France, 94257
        • Not yet recruiting
        • Fondation Vallée, Gentilly
        • Contact:
        • Principal Investigator:
          • JOUSSELME Catherine
      • Lille, France, 59037
        • Not yet recruiting
        • CHRU de Lille
        • Contact:
        • Principal Investigator:
          • JARDRI Renaud
      • Nice, France, 62000
        • Not yet recruiting
        • Chu De Nice
        • Contact:
        • Principal Investigator:
          • ASKENAZY Florence
      • Paris, France, 75013
        • Recruiting
        • Pitié Salpêtrière
        • Contact:
        • Principal Investigator:
          • LAURENT-LEVINSON Claudine, M.D., Ph.D.
      • Rouen, France, 76031
        • Not yet recruiting
        • CHU de Rouen
        • Contact:
        • Principal Investigator:
          • GERARDIN Priscile
      • Rouen, France, 76031
        • Not yet recruiting
        • CHU de Rouvray
        • Contact:
        • Principal Investigator:
          • GERARDIN Priscile

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Lifetime Dimensions of Psychosis Scale-Child and Adolescent Version
Time Frame: 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.
4 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clinical global impressions scale - change version
Time Frame: at 5 years
score on a 7 point scale ; worse is 7
at 5 years
Cortical gray matter volume (Magnetic Resonance Imaging)
Time Frame: up to 4 months
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
Time Frame: 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
at 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assistance Publique - Hôpitaux de Paris

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Claudine LAURENT-LEVINSON, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 2, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 25, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 1, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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