clinical, neuroimaging and DNA assessments
OtherSelected assessments, including evaluation of treatment response to specific antipsychotic drugs, will be performed at follow-up visits after 1, 3 and 5 years
NCT Number: NCT04370730
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.
Interested in participating?
Request Info7 year–20 year
All sexes
Interventional
Not applicable
Fondation Vallée, Gentilly, Gentilly, France
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for the Patient:
Inclusion criteria
for parents or siblings wishing to participate in the genetic part of the study :
Exclusion criteria
Selected assessments, including evaluation of treatment response to specific antipsychotic drugs, will be performed at follow-up visits after 1, 3 and 5 years
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.
Time frame: at 5 years
score on a 7 point scale ; worse is 7
Time frame: up to 4 months
Statistical differences among the four clinical clusters in the summary measure of cortical gray matter volume
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
Contact information is provided by the study sponsor or research team.
Anne BISSERY
CONTACT
1 42 16 34 32 ext. +33
Claudine LAURENT-LEVINSON, M.D., Ph.D.
CONTACT
1 42 16 23 44 ext. +33
Assistance Publique - Hôpitaux de Paris
Other
Dimensional and Developmental Approach to Psychotic Episodes in Children and Adolescents: Impact on Clinical Management
Acronym: PSYDEV
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View the official ClinicalTrials.gov record (opens in a new tab)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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