Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2018-A01072-53 | Other Identifier | ANSM |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| prospective cohort | Other | prospective monitoring of children and adolescents with schizophrenia and related psychotic disorders |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical global impressions scale - change version | score on a 7 point scale ; worse is 7 | at 5 years |
| Cortical gray matter volume (Magnetic Resonance Imaging) | Statistical differences among the four clinical clusters in the summary measure of cortical gray matter volume |
Not provided
Inclusion Criteria for the Patient:
Inclusion Criteria for parents or siblings wishing to participate in the genetic part of the study :
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Claudine LAURENT-LEVINSON, M.D., Ph.D. | Contact | 1 42 16 23 44 | +33 | claudine.laurent@aphp.fr |
| Anne BISSERY | Contact | 1 42 16 34 32 | +33 | anne.bissery@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Claudine LAURENT-LEVINSON | Assistance Publique - Hôpitaux de Paris | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondation Vallée, Gentilly | Not yet recruiting | Gentilly | 94257 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| D018450 | Disease Progression |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
Not provided
Not provided
| ID | Term |
|---|---|
| D059906 | Neuroimaging |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003943 | Diagnostic Techniques, Neurological |
Not provided
Not provided
prospective cohort study
Not provided
Not provided
Not provided
Not provided
| up to 4 months |
| Stability of clinical profile on Lifetime Dimensions of Psychosis Scale-Child and Adolescent Version | 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 |
| CHRU de Lille | Not yet recruiting | Lille | 59037 | France |
|
| CHU de Nice | Not yet recruiting | Nice | 62000 | France |
|
| Pitié Salpétrière | Recruiting | Paris | 75013 | France |
|
| CHU de Rouen | Not yet recruiting | Rouen | 76031 | France |
|
| CHU de Rouvray | Not yet recruiting | Rouen | 76031 | France |
|
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008919 | Investigative Techniques |