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NCT Number: NCT02007928

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

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.

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Key information

Conditions

Dissociative Disorders Mental Disorders Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CH D'antibes, Antibes, Alpes-Maritime, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Clinical assessment and laboratory

    Time frame: 12 months

    • 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 outcomes

  1. Risk Factors

    Time frame: 12 months

    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).

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

    Time frame: 12 months

    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

  3. Scores

    Time frame: 12 months

    • 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).
    • 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).
    • Evaluation of the evolution of therapeutic alliance at M1, at M3, M6, M9 and at M12

  4. Quality of life

    Time frame: 12 months

    • 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)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Dec 11, 2013
Registry last updated
Feb 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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