Clinical trial NCT04370730: Dimensional and Developmental Profiles of Psychosis in Children and Adolescents
Official title: Dimensional and Developmental Approach to Psychotic Episodes in Children and Adolescents: Impact on Clinical Management
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Schizophrenia
Psychotic Disorders
Keywords: schizophrenia
schizophrenia spectrum
psychosis
early-onset
cognition
magnetic resonance imaging
course of illness
treatment response
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-05-01
Enrollment: 200
Sex: ALL
Minimum age (years): 7
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: prospective cohort study
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Lifetime Dimensions of Psychosis Scale-Child and Adolescent Version
timeFrame: 4 months
Secondary outcomes:
measure: Clinical global impressions scale - change version
timeFrame: at 5 years
measure: Cortical gray matter volume (Magnetic Resonance Imaging)
timeFrame: up to 4 months
measure: Stability of clinical profile on Lifetime Dimensions of Psychosis Scale-Child and Adolescent Version
timeFrame: at 5 years
Other outcomes:
Locations:
city: Gentilly
country: France
facility: Fondation Vallée, Gentilly
city: Lille
country: France
facility: CHRU de Lille
city: Nice
country: France
facility: CHU de Nice
city: Paris
country: France
facility: Pitié Salpétrière
city: Rouen
country: France
facility: CHU de Rouen
city: Rouen
country: France
facility: CHU de Rouvray
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Claudine LAURENT-LEVINSON
role: STUDY_DIRECTOR
References: