Clinical trial NCT02007928: Assessment of Adverse Events in a Naive Pediatric Population Treated With an Antipsychotic
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dissociative Disorders
Schizophrenia
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2013-12-11
Enrollment: 200
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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

Eligibility criteria: Inclusion Criteria:

* Male or female patients
* Aged from 6 to 18 years
* In whom antipsychotic treatment is indicated
* Who have never been treated with antipsychotic medication (other than metoclopramide (Primperan®) for pediatric indications) or with a history of antipsychotic over a maximum period of three consecutive months and discontinued for at least 6 months. .

The non-inclusion criteria:

* Any

The exclusion criteria:

* Refusal or withdrawal of consent by the patient or his/her parents.

Primary outcomes:
measure: Clinical assessment and laboratory
timeFrame: 12 months
Secondary outcomes:
measure: Risk Factors
timeFrame: 12 months
measure: Persistence and/or reversibility of adverse events before the end of the study
timeFrame: 12 months
measure: Scores
timeFrame: 12 months
measure: Quality of life
timeFrame: 12 months
Other outcomes:
Locations:
city: Cannes
country: France
facility: CH de Cannes
state: Alpes-maritimes
city: Nice
country: France
facility: Service de psychiatrie de l'enfant et de l'adolescent
state: Alpes-Maritimes
city: Antibes
country: France
facility: CH D'antibes
state: Alpes-Maritime
city: Poitiers
country: France
facility: CH Henri laborit
state: Charente Maritime
city: Gentilly
country: France
facility: Fondation Vallée
state: Paris
city: Bron
country: France
facility: Ch le Vinatier
city: Lille
country: France
facility: CHRU de Lille
city: Limoges
country: France
facility: Centre Hospitalier Spécialisé Esquirol
city: Lyon
country: France
facility: CH St Jean de Dieu
city: Lyon
country: France
facility: HCL
city: Nancy
country: France
facility: CHU de Nancy
city: Nantes
country: France
facility: CHU de Nantes
city: Paris
country: France
facility: AP-HP
city: Toulouse
country: France
facility: CHU de Toulouse
Study officials:
affiliation: CHU de Nice - 52 avenue de la Californie 06 200 Nice
name: MENARD Marie-Line, PH
role: STUDY_CHAIR
References:
citation: Menard ML, Thummler S, Giannitelli M, Olliac B, Bonnot O, Cohen D, Askenazy F; ETAPE Study group. Incidence of adverse events in antipsychotic-naive children and adolescents treated with antipsychotic drugs: a French multicentre naturalistic study protocol (ETAPE). BMJ Open. 2016 Apr 6;6(4):e011020. doi: 10.1136/bmjopen-2015-011020.