Schizophrenia Clinical Trial
Official title:
Assessment of Incidence of Adverse Events in a Naive Pediatric Population Treated With an (Typical and Atypical) Antipsychotic Drug Over 12 Months Follow-up
We propose a prospective multicenter study, whose originality lies in the inclusion of the
naive child and adolescent population. Its purpose is to evaluate the incidence of adverse
events related to the use of l antipsychotic drugs in children and adolescents with no
history of taking such drugs.
The inclusion criteria will be: (1) male or female inpatients, (2) aged from 6 to 18 years,
(3) requiring antipsychotic treatment, (4) receiving antipsychotic drug for less than 28 days
without taking antipsychotic before or with a history of antipsychotic over a maximum period
of three consecutive months and discontinued for at least 6 months.
Therapeutic monitoring during the 12 month study period will include clinical assessments and
laboratory testing. These assessments will be performed before treatment (at inclusion), and
at 1, 3, 6, 9, 12 months after the introduction of the antipsychotic drug.
a prospective multicenter study, whose originality lies in the inclusion of the naive child and adolescent population ;
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