Dimensional and Developmental Profiles of Psychosis in Children and Adolescents
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-20
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
clinical, neuroimaging and DNA assessments
Other interventionSelected assessments, including evaluation of treatment response to specific antipsychotic drugs, will be performed at follow-up visits after 1, 3 and 5 years
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: prospective cohortOther 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
4 monthsSecondary outcomes
1
Clinical global impressions scale - change version
score on a 7 point scale ; worse is 7
Time frame
at 5 years2
Cortical gray matter volume (Magnetic Resonance Imaging)
Statistical differences among the four clinical clusters in the summary measure of cortical gray matter volume
Time frame
up to 4 months3
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
Time frame
at 5 yearsSponsors and contacts
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Source ClinicalTrials.gov