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

NCT ID: NCT02007928

Last Updated: 2018-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2017-07-31

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

Conditions

Dissociative Disorders; Schizophrenia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Rispéridone, aripiprazole, olanzapine

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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. .

• Any

Exclusion Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MENARD Marie-Line, PH

Role: STUDY_CHAIR

CHU de Nice - 52 avenue de la Californie 06 200 Nice

Locations

CH de Cannes

Cannes, Alpes-maritimes, France

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

Nice, Alpes-Maritimes, France

CH D'antibes

Antibes, Alpes-Maritime, France

CH Henri laborit

Poitiers, Charente Maritime, France

Fondation Vallée

Gentilly, Paris, France

Ch le Vinatier

Bron, , France

CHRU de Lille

Lille, , France

Centre Hospitalier Spécialisé Esquirol

Limoges, , France

CH St Jean de Dieu

Lyon, , France

HCL

Lyon, , France

CHU de Nancy

Nancy, , France

CHU de Nantes

Nantes, , France

AP-HP

Paris, , France

CHU de Toulouse

Toulouse, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 27053275 (View on PubMed)

Other Identifiers

12-PP-12

Identifier Type: -

Identifier Source: org_study_id