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

Centre Hospitalier Universitaire de Nice

Status: Completed

Conditions: Schizophrenia; Dissociative Disorders

Treatments: Other: Rispéridone, aripiprazole, olanzapine

Study type: Interventional

Funder types: Other

Identifiers

NCT02007928

12-PP-12

Details and patient eligibility

About

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.

Full description

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

Enrollment: 200 patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

rispéridone, aripiprazole, olanzapine...

Other group

Description:

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.

Treatment:

Other: Rispéridone, aripiprazole, olanzapine