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NCT Number: NCT04370730

Dimensional and Developmental Profiles of Psychosis in Children and Adolescents

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.

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Key information

Age range

7 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondation Vallée, Gentilly, Gentilly, France

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for the Patient:

  • 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).

Inclusion criteria

for parents or siblings wishing to participate in the genetic part of the study :

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Clinical global impressions scale - change version

    Time frame: at 5 years

    score on a 7 point scale ; worse is 7

  2. 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

  3. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Anne BISSERY

CONTACT

[email protected]

1 42 16 34 32 ext. +33

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

CONTACT

[email protected]

1 42 16 23 44 ext. +33

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: PSYDEV

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
May 1, 2020
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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