NCT02007928

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

April 23, 2013

Completed
8 months until next milestone

First Posted

Study publicly available on registry

December 11, 2013

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

February 5, 2018

Status Verified

February 1, 2018

Enrollment Period

4.1 years

First QC Date

April 23, 2013

Last Update Submit

February 1, 2018

Conditions

Dissociative DisordersSchizophrenia

Outcome Measures

Primary Outcomes (1)

  • Clinical assessment and laboratory

    1. 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), 2. 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 Outcomes (4)

  • Risk Factors

    12 months

  • Persistence and/or reversibility of adverse events before the end of the study

    12 months

  • Scores

    12 months

  • Quality of life

    12 months

Study Arms (1)

rispéridone, aripiprazole, olanzapine...

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.

Other: Rispéridone, aripiprazole, olanzapine

Interventions

Rispéridone, aripiprazole, olanzapineOTHER

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...

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

CH de Cannes

Cannes, Alpes-maritimes, France

Location

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

Nice, Alpes-Maritimes, 06200, France

Location

CH D'antibes

Antibes, Alpes-Maritime, France

Location

CH Henri laborit

Poitiers, Charente Maritime, 86328, France

Location

Fondation Vallée

Gentilly, Paris, France

Location

Ch le Vinatier

Bron, 69678, France

Location

CHRU de Lille

Lille, France

Location

Centre Hospitalier Spécialisé Esquirol

Limoges, France

Location

CH St Jean de Dieu

Lyon, 69355, France

Location

HCL

Lyon, France

Location

CHU de Nancy

Nancy, France

Location

CHU de Nantes

Nantes, France

Location

AP-HP

Paris, France

Location

CHU de Toulouse

Toulouse, France

Location

Related Publications (1)

  • 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.

    PMID: 27053275DERIVED

MeSH Terms

Conditions

Dissociative DisordersSchizophrenia

Interventions

RisperidoneAripiprazoleOlanzapine

Condition Hierarchy (Ancestors)

Mental DisordersSchizophrenia Spectrum and Other Psychotic Disorders

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperazinesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingBenzodiazepinesBenzazepines

Study Officials

  • MENARD Marie-Line, PH

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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2013

First Posted

December 11, 2013

Study Start

April 1, 2013

Primary Completion

May 1, 2017

Study Completion

July 1, 2017

Last Updated

February 5, 2018

Record last verified: 2018-02

Locations

FR(14)