NCT02007928

Assessment of Adverse Events in a Naive Pediatric Population Treated With an Antipsychotic

Assessment of Incidence of Adverse Events in a Naive Pediatric Population Treated With an (Typical and Atypical) Antipsychotic Drug Over 12 Months Follow-up

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Centre Hospitalier Universitaire de Nice · Academic / Other
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

Conditions

• Dissociative Disorders
• Schizophrenia

Interventions

Type	Name	Description
OTHER	Rispéridone, aripiprazole, olanzapine	Study: We propose a prospective, interventional multicenter study. Method: Both in and out patients may be included in the study Patients will be recruited over a period of 24 months. They will be followed up for 12 months. Each patient will receive one year of therapeutic monitoring after the introduction of the antipsychotic drug. The therapeutic monitoring will include clinical, electrocardiographical, and laboratory assessments. These assessments are performed at baseline (before prescribing treatment) and at 1 month (M1), at 3 months (M3), 6 months (M6), 9 months (M9), and at 12 months (M12) after the first prescription of the antipsychotic drug.

Timeline

• Start date: 2013-04-01
• Primary completion: 2017-05-01
• Completion: 2017-07-01
• First posted: 2013-12-11
• Last updated: 2018-02-05

Locations

14 sites across 1 country: France