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

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02007928
• Other study ID #: 12-PP-12
• Status: Completed
• Phase: N/A
• First received: April 23, 2013
• Last updated: February 1, 2018
• Start date: April 2013
• Est. completion date: July 2017

Study information

• Verified date: February 2018
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Conversion Disorder
• Dissociative Disorders
• Schizophrenia

Intervention

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.

Locations

Country	Name	City	State
France	CH D'antibes	Antibes	Alpes-Maritime
France	Ch le Vinatier	Bron
France	CH de Cannes	Cannes	Alpes-maritimes
France	Fondation Vallée	Gentilly	Paris
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	Service de psychiatrie de l'enfant et de l'adolescent	Nice	Alpes-Maritimes
France	AP-HP	Paris
France	CH Henri laborit	Poitiers	Charente Maritime
France	CHU de Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical assessment and laboratory	Clinical Assessment A: General assessment of adverse events by the Pediatric Adverse Event Rating Scale (PAERS-Clinician) (March et al, 2007). Performed at each visit.; B: Somatic parameters to be monitored: weight, size, body mass index (BMI), abdominal perimeter, blood pressure, temperature. Performed at each visit.; C: Electrocardiographic assessment of QT interval D: Neuromuscular adverse events: Abnormal Involuntary Movement Scale (AIMS) (Guy, 1976a), Barnes Akathisia Rating Scale (BARS) (Barnes, 1989), Simpson Angus Scale (SAS) (Simpson and Angus, 1970), Bush Francis Catatonia Rating Scale (BFCRS) (Bush and al, 1996),; Laboratory assessments. The following laboratory tests will be obtained on each visit: complete blood count, liver enzymes, creatine phosphokinase, glycemia, cholesterol (total, light, and heavy), triglycerides, CRPus, prolactin, insulin, HOMA, HbA1C, vitamin D.	12 months
Secondary	Risk Factors	Tanner score of puberty at inclusion: population will be divided into three groups: prepubertal (stage = 1); currently in puberty (stages 2 to 4) and puberty adult (stage 5).; Drug history: age at initiation of treatment, the first-line atypical antipsychotic drug, other treatment(s), age of onset of disorder for which the prescription of an atypical antipsychotic drug was indicated.; The diagnosis is made using the Schedule for Affective Disorders and Schizophrenia for School Age Children (Kiddie-SADS) (Kaufman and al, 1997).	12 months
Secondary	Persistence and/or reversibility of adverse events before the end of the study	The investigators propose the following definitions for this study, based on published data and our preliminary study: A persistent adverse event is an event that is still present 3 months after treatment cessation; A reversible adverse event is an event that has fully resolved 3 months after treatment cessation	12 months
Secondary	Scores	4) Evaluation of the evolution of disorder severity at baseline, at M1, M3, M6, M9 and M12 The clinical severity of the disorder will be assessed using the Clinical Global Impressions Scales (CGI) (Guy, 1976b).; 5) Evaluation of the evolution of social functioning at baseline, at M6 and at M12 Social functioning will be assessed by the Child Global Assessment Scale (CGAS).; 6) Evaluation of the evolution of therapeutic alliance at M1, at M3, M6, M9 and at M12	12 months
Secondary	Quality of life	7) Evaluation of the evolution of quality of life at baseline, at M1, M3, M6, M9 and at M12 Quality of life will be assessed by the Sheehan Disability Scale 8) The evaluation of the evolution of eating disorder at baseline, at M1, M3, M6, M9 and at M12 will be assessed by the Questionnaire of Eating and Weight Patterns 9) The evaluation of the evolution of physical activity at baseline, at M1, M3, M6, M9 and at M12 will be assessed by Dennison measure 10) Evaluation of the evolution of DSM diagnosis at baseline and at M12 by the Schedule for Affective Disorders and Schizophrenia for School Age Children (Kiddie-SADS)	12 months