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Clinical Trial Summary

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.


Clinical Trial Description

a prospective multicenter study, whose originality lies in the inclusion of the naive child and adolescent population ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02007928
Study type Interventional
Source Centre Hospitalier Universitaire de Nice
Contact
Status Completed
Phase N/A
Start date April 2013
Completion date July 2017

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