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

Primary Purpose

Dissociative Disorders, Schizophrenia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Rispéridone, aripiprazole, olanzapine
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Dissociative Disorders

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CH de Cannes
  • Service de psychiatrie de l'enfant et de l'adolescent
  • CH D'antibes
  • CH Henri laborit
  • Fondation Vallée
  • Ch le Vinatier
  • CHRU de Lille
  • Centre Hospitalier Spécialisé Esquirol
  • CH St Jean de Dieu
  • HCL
  • CHU de Nancy
  • CHU de Nantes
  • AP-HP
  • CHU de Toulouse

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

rispéridone, aripiprazole, olanzapine...

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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
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
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)

Full Information

First Posted
April 23, 2013
Last Updated
February 1, 2018
Sponsor
Centre Hospitalier Universitaire de Nice
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1. Study Identification

Unique Protocol Identification Number
NCT02007928
Brief Title
Assessment of Adverse Events in a Naive Pediatric Population Treated With an Antipsychotic
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dissociative Disorders, Schizophrenia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
rispéridone, aripiprazole, olanzapine...
Arm Type
Other
Arm 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.
Intervention Type
Other
Intervention Name(s)
Rispéridone, aripiprazole, olanzapine
Intervention 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.
Primary Outcome Measure Information:
Title
Clinical assessment and laboratory
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Risk Factors
Description
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).
Time Frame
12 months
Title
Persistence and/or reversibility of adverse events before the end of the study
Description
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
Time Frame
12 months
Title
Scores
Description
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
Time Frame
12 months
Title
Quality of life
Description
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)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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. . The non-inclusion criteria: Any The exclusion criteria: Refusal or withdrawal of consent by the patient or his/her parents.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MENARD Marie-Line, PH
Organizational Affiliation
CHU de Nice - 52 avenue de la Californie 06 200 Nice
Official's Role
Study Chair
Facility Information:
Facility Name
CH de Cannes
City
Cannes
State/Province
Alpes-maritimes
Country
France
Facility Name
Service de psychiatrie de l'enfant et de l'adolescent
City
Nice
State/Province
Alpes-Maritimes
ZIP/Postal Code
06200
Country
France
Facility Name
CH D'antibes
City
Antibes
State/Province
Alpes-Maritime
Country
France
Facility Name
CH Henri laborit
City
Poitiers
State/Province
Charente Maritime
ZIP/Postal Code
86328
Country
France
Facility Name
Fondation Vallée
City
Gentilly
State/Province
Paris
Country
France
Facility Name
Ch le Vinatier
City
Bron
ZIP/Postal Code
69678
Country
France
Facility Name
CHRU de Lille
City
Lille
Country
France
Facility Name
Centre Hospitalier Spécialisé Esquirol
City
Limoges
Country
France
Facility Name
CH St Jean de Dieu
City
Lyon
ZIP/Postal Code
69355
Country
France
Facility Name
HCL
City
Lyon
Country
France
Facility Name
CHU de Nancy
City
Nancy
Country
France
Facility Name
CHU de Nantes
City
Nantes
Country
France
Facility Name
AP-HP
City
Paris
Country
France
Facility Name
CHU de Toulouse
City
Toulouse
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
27053275
Citation
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.
Results Reference
derived

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

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