Overview

This trial is active, not recruiting.

Conditions dissociative disorders, schizophrenia
Treatment rispéridone, aripiprazole, olanzapine
Phase phase 4
Sponsor Centre Hospitalier Universitaire de Nice
Start date April 2013
End date May 2016
Trial size 200 participants
Trial identifier NCT02007928, 12-PP-12

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Arm
(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.
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.

Primary Outcomes

Measure
Clinical assessment and laboratory
time frame: 12 months

Secondary Outcomes

Measure
Risk Factors
time frame: 12 months
Persistence and/or reversibility of adverse events before the end of the study
time frame: 12 months
Scores
time frame: 12 months
Quality of life
time frame: 12 months

Eligibility Criteria

Male or female participants from 6 years up to 17 years old.

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.

Additional Information

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
Description a prospective multicenter study, whose originality lies in the inclusion of the naive child and adolescent population
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Centre Hospitalier Universitaire de Nice.