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

NACompletedINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

April 30, 2013

Primary Completion Date

May 31, 2017

Study Completion Date

July 31, 2017

Conditions
Dissociative DisordersSchizophrenia
Interventions
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."

Trial Locations (14)

69355

CH St Jean de Dieu, Lyon

69678

Ch le Vinatier, Bron

86328

CH Henri laborit, Poitiers

Unknown

CH de Cannes, Cannes

CH D'antibes, Antibes

Fondation Vallée, Gentilly

CHRU de Lille, Lille

Centre Hospitalier Spécialisé Esquirol, Limoges

HCL, Lyon

CHU de Nancy, Nancy

CHU de Nantes, Nantes

AP-HP, Paris

CHU de Toulouse, Toulouse

06200

Service de psychiatrie de l'enfant et de l'adolescent, Nice

All Listed Sponsors
lead

Centre Hospitalier Universitaire de Nice

OTHER

NCT02007928 - Assessment of Adverse Events in a Naive Pediatric Population Treated With an Antipsychotic | Biotech Hunter | Biotech Hunter