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Dissociative DisordersNCT02007928

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

A study testing Rispéridone, aripiprazole, olanzapine in people with Dissociative Disorders and Schizophrenia, run by Centre Hospitalier Universitaire de Nice at 14 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 6 to 17 years
Conditions the study is for
Dissociative Disorders, Schizophrenia
What is being tested?
Rispéridone, aripiprazole, olanzapine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
14 sitesFrance
Study dates
Apr 2013to Jul 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

None listed.

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

France14 sites

  • CH D'antibes

    Antibes, Alpes-Maritime

  • Ch le Vinatier

    Bron, 69678

  • CH de Cannes

    Cannes, Alpes-maritimes

  • Fondation Vallée

    Gentilly, Paris

  • CHRU de Lille

    Lille

  • Centre Hospitalier Spécialisé Esquirol

    Limoges

  • CH St Jean de Dieu

    Lyon, 69355

  • HCL

    Lyon

  • CHU de Nancy

    Nancy

  • CHU de Nantes

    Nantes

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

    Nice, Alpes-Maritimes, 06200

  • AP-HP

    Paris

  • CH Henri laborit

    Poitiers, Charente Maritime, 86328

  • CHU de Toulouse

    Toulouse

Other trials in France

About this study

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

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.

Read the detailed description

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

Being tested
Rispéridone, aripiprazole, olanzapine
Medical subject headings
Dissociative Disorders, Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT02007928
Study groupRoleWhat they receive
rispéridone, aripiprazole, olanzapine...OtherStudy: 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.
Receives: Other: Rispéridone, aripiprazole, olanzapine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 months

Secondary outcomes (4)

  1. 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).

    Measured: 12 months

  2. 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

    Measured: 12 months

  3. Scores

    1. 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).
    2. 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).
    3. Evaluation of the evolution of therapeutic alliance at M1, at M3, M6, M9 and at M12

    Measured: 12 months

  4. Quality of life

    1. 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)

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2013 (estimated)
  2. Study startApr 2013
  3. Primary completionMay 2017
  4. Study completionJul 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02007928
Sponsor's protocol ID
12-PP-12
Status last verified
Feb 2018
First submitted
23 Apr 2013
Last updated
5 Feb 2018
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 27053275

Questions about this trial

What is this clinical trial studying?

A study testing Rispéridone, aripiprazole, olanzapine in people with Dissociative Disorders and Schizophrenia, run by Centre Hospitalier Universitaire de Nice at 14 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical assessment and laboratory (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02007928, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2018.

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