severe behavioral disorders in mental retardation, autistic syndromes schizophrenia psychosis MedDRA version: 16.0 Level: LLT Classification code 10033877 Term: Paranoid type schizophrenia System Organ Class: 100000004873
Conditions
Interventions
Pharmaceutical Form:
Sponsors
CHU de Nice
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Male or female patients •6 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: none
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main purpose of this study is to evaluate the incidence of adverse events related to antipsychotic drugs in a French pediatric population with no history of taking antipsychotic drugs.;Secondary Objective: 1) To study risk factors associated with the occurrence of adverse events 2) Study risk factors associated with changing the antipsychotic drug used during study: • age at onset of treatment • pubertal status at baseline • age at onset of disorder for which the prescription of antipsychotic drug was indicated • the antipsychotic drug prescribed • other concomitant treatment(s) • the DSM-IV diagnosis 3) Study of the persistence and/or reversibility of adverse events before the end of the study 4) Evaluation of the evolution of the disorder’s severity 5) Evaluation of the evolution of social functioning 6) Evaluation of the evolution of the therapeutic alliance 7) Evaluation of the evolution of quality of life 8) Evaluation of the evolution of the eating behaviors 9) Evaluation of the evolution of the physical activity;Primary end point(s): A- Clinical Assessment 1-General assessment of adverse events by the Pediatric Adverse Event Rating Scale (PAERS-Clinician) (March et al, 2007). The PAERS provides a convenient and simple way to ascertain adverse events in children and adolescents treated with atypical antipsychotic drugs. 2-Somatic parameters to be monitored: weight, size, body mass index (BMI), abdominal perimeter, blood pressure, temperature. -Hypertension is defined as follows (Simonetti et al, 2010): Systolic blood pressure: from 1 to 17 years: > 100 + (age x 2) mm / Hg Diastolic blood pressure: from 1 to 10 years: > 60 + (age x 2) mm / Hg, from 11 to 17 years: > 70 + age mm / Hg Adolescents over 17 years: a systolic blood pressure > 160 mm / Hg or diastolic blood pressure > 90 mm / Hg. 3-Electrocardiographic assessment of QT interval: The heart rate (in beats per minute), measured using the duration of the RR segment, and the unco | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Risk factors Tanner score of puberty at inclusion: population will be divided into three groups: prepubertal (stage = 1); currently in puberty (stages 2 to 4) and puberty adult (stage 5). Drug history: age at initiation of treatment, the first-line atypical antipsychotic drug, other treatment(s), age of onset of disorder for which the prescription of an atypical antipsychotic drug was indicated. The diagnosis is made using the Schedule for Affective Disorders and Schizophrenia for School Age Children (Kiddie-SADS) (Kaufman and al, 1997), a semi-structured interview for patients aged 6 to 18 years. It was translated into French by Mouren-Simeoni in 2002. It establishes a categorical diagnosis based on criteria from the DSM-IV-R. It contains the CGAS. Persistence and/or reversibility of adverse events before the end of the study There is no official pharmacovigilance guidance on the persistence and reversibility of adverse events. We propose the following definitions for this study, based on published data and our preliminary study: • A persistent adverse event is an event that is still present 3 months after treatment cessation • A reversible adverse event is an event that has fully resolved 3 months after treatment cessation This group will be monitored using the same criteria as the group still receiving treatment, except for the laboratory and ECG assessments, which will be performed only on the last visit M12. The reason for treatment cessation will be noted in the visit subsequent to the decision to cease treatment. Evaluation of the evolution of disorder severity at baseline, M3, M6, M9 and M12 The clinical severity of the disorder will be assessed using the Clinical Global Impressions Scales (CGI). The CGI was developed to provide a global measure of the severity of a patient’s clinical condition and improvement or deterioration during clinical studies. The clinician uses his or her clinical experience of this patient | — |
Countries
France
Contacts
Public ContactCaillon
CHU de Nice
Outcome results
None listed